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Top drugs and pharmaceutical companies of 2019 by revenues

Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues. Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively. Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention. GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion). US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic. Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)

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29 Apr 2020

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Seven of your facilities are out of compliance, FDA tells Wockhardt; Mylan’s EpiPen sales crash

In Phispers this week, there is news on how alternatives to Mylan’s EpiPen have eaten into its US sales. Warning letters posted by the FDA revealed that it considers seven of Wockhardt’s sites out of compliance and there is more trouble in the works for the former Ranbaxy promoters. And, Novartis faces punitive action in South Korea. Read on. Mylan’s EpiPen sees drastic drop in market share in Jan-Feb 2017 Last year, Mylan was in the news for hiking the price of EpiPen by 500 percent. At that time, there were no generic avatars of the life-saving anti-allergy medicine available in the US market. But now, the scenario has changed. Data from athenahealth network shows that prescriptions for alternatives of Mylan’s EpiPen have “quadrupled since the beginning of 2017”. More than 60,000 prescriptions for epinephrine auto-injectors, written for 50,000 patients by more than 1,400 healthcare providers in the US, were evaluated by researchers at athenahealth between January 2016 and February 2017. The share of alternatives to EpiPen have significantly increased in the last two months, as opposed to the end of 2016. “At the end of 2016, EpiPen alternatives made up only 5.3 percent of prescriptions for epinephrine auto-injectors. By the last full week of February, that figure had grown to 28.9 percent,” athenahealth said. The key reason for this sudden and significant shift is the lower price tags of the EpiPen alternatives. Most of these alternatives are priced at a fraction of the cost of Mylan’s EpiPen. Moreover, insurers could also be affecting the prescription patterns. In January this year, health insurance company Cigna began to cover only generic options to EpiPen. Seven of your facilities are out of compliance, FDA tells Wockhardt This week, US FDA posted the warning letter issued to Wockhardt's US-based Morton Grove facility. The concerns raised by the investigators ranged from Wockhardt's “investigations into out-of-specification (OOS) test results” that were found to be neither thorough, nor timely, nor based on scientific rationales” to the “original results” that were “invalidated without scientific justification under the protocol and only re-test results were reported as part of batch release decisions.” Of serious concern is the fact that in the warning letter the FDA has said: "At this time, seven Wockhardt facilities (including Morton Grove) are considered out of compliance with cGMP. These repeated failures at multiple sites demonstrate your company’s inadequate oversight and control over the manufacture of drugs. In your responses to the various actions listed above, including during multiple meetings with FDA, you have repeatedly discussed and promised corporate-wide corrective actions. Yet, when FDA inspects or returns to other Wockhardt facilities, similar violations are shown to persist.” Second FDA warning letter to Megafine over "calibration records in trash” Megafine Pharma received its second FDA warning letter in less than a year for its facility which manufactures active pharmaceutical ingredient (API) intermediates. The Megafine plant in Vapi (Gujarat) was inspected last September and once again data integrity was the primary cause of concern raised by the FDA. The facility was “issuing analysts with blank controlled document forms that had already been approved and signed”. Moreover, FDA investigators found torn, partially complete Quality Assurance-signed calibration records in the trash and saw QA staff shredding documents without reason. In another observation, "analysts reprocessed data up to 12 times, and only included the final result in the report for review by Quality Assurance. Your Deputy Manager, Quality Control stated that it is common practice to ‘play with parameters’ to get the proper integration." FDA investigators also noticed that the interior surfaces of the drug manufacturing equipment were not as clean as required. Megafine's API plant in Lakhmapur, Nashik, was placed on FDA's Import Alert list in 2015. Ghosts of Ranbaxy continue to haunt Singh brothers Former promoters of Ranbaxy — Malvinder and Shivinder Singh — were directed by the Delhi High Court to seek its permission before selling any of their unencumbered assets. This puts in jeopardy reported plans of the brothers to sell their stakes in companies like Fortis Healthcare and Religare, although the court hasn’t passed an outright injunction against such an exercise. The Singh brothers have also been directed to furnish details of all unencumbered assets in order to ascertain that they have enough funds to cover an arbitration payment of more than US$ 3.74 billion (Rs 250 billion) granted to Daiichi Sankyo by a Singapore tribunal last year. The brothers have been engaged in a legal battle with Daiichi Sankyo, which bought out Ranbaxy in 2008 for US$ 4.1billion. Daiichi had accused the Singh brothers of misrepresenting the problems facing Ranbaxy when it acquired the firm. In 2014, Daiichi sold Ranbaxy to Sun Pharma. Investors demand cut in new GSK CEO’s prospective pay package A number of investors in Britain’s largest drug company — GlaxoSmithKline (GSK) — are reportedly putting pressure on its board to reduce a proposed multi-million pound pay deal for its new CEO, Emma Walmsley. They want Walmsley’s package to be sufficiently lower than the one awarded to her predecessor — Sir Andrew Witty — who is slated to retire later this month. His base salary is US$ 1.34 million (£1.1million) a year, while Walmsley’s proposed base salary is US$ 1.22 million (£1 million) a year, said news reports. Some shareholders don’t think her proposed pay package fits Walmsley’s work experience. She is set to become Big Pharma’s first female CEO. But her resume is heavily tilted towards consumer products. Till recently, she was heading GSK’s consumer health joint venture. And prior to 2010 (a year when she joined GSK), she spent 17 years at cosmetics company — L’Oreal. GSK is in “active consultations with shareholders” and is “acutely aware of the need for a balanced and responsible approach to remuneration,” a spokesperson said. Children with AIDS write to India’s PM about Cipla’s Lopinavir When the Indian government failed to clear its dues, Cipla — the only manufacturer of Lopinavir syrup (a child-friendly HIV drug) — stopped production of the drug. As a result, children living with HIV (CLHIV) have written to Prime Minister Narendra Modi for help. The letter dated March 4 is signed by 637 children ranging from ages three to 19. “The pharmaceutical company Cipla has in various forums cited delay in payments by the national program for the HIV medicines by several years and even non-payment of its dues in many cases. Profits on child doses of HIV medicines are small and delayed payments are having a chilling effect on the ability of the National AIDS Control Organization (NACO) to convince the company to participate in the bids it invited annually,” the letter said. Cipla is the dominant player in the Indian market across the HIV segment. Even though the Indian government has failed to pay Cipla for consignments it had sent back in 2014, the company has not stopped participating in government tenders. The Health Ministry, on the other hand, says it has instructed State AIDS Control Societies (SACS) to purchase the drug from local markets. “An emergency tender has been placed but we have instructed SACS and state governments to purchase from local markets,” Arun Panda, Additional Secretary, Health Ministry, said. Novartis faces drug ban in South Korea over bribe issue Novartis is due to face additional punitive measures from the health ministry of South Korea later this month for allegedly providing illegal bribes to local doctors in exchange for prescribing its drugs. Last week, the Korean Ministry of Health and Welfare said it is reviewing its own administrative actions against Novartis Korea, which could take the form of a fine or a lifting of insurance benefits on drugs sold by the company in South Korea. Novartis is headquartered in Basel, Switzerland. Last week, the Korean Ministry of Food and Drug Safety had slapped Novartis Korea with a fine of US$ 174,937 (200 million won) and a three-month sales ban on 12 drugs, including variations of the company’s flagship dementia drug Exelon. According to the ministry, this 200 million-won fine is equivalent to a three-month ban on 30 drugs, including Novartis’ top-selling diabetes drug — Galvus. Korea’s punitive measures against Novartis Korea have come a year after Seoul prosecutors began a probe into a massive bribery scam that involved the company’s executives and employees. In August last year, six former and current Novartis employees in South Korea were indicted over illegal practices to boost sales of the company's drugs. Samsung Bioepis wins high-stakes case against AbbVie’s Humira There is more news from South Korea. The Seoul-headquartered Samsung Bioepis, a biopharmaceutical company, won a high-stakes court case last week against US drug firm AbbVie for a biosimilar of the world's best-selling drug — Humira. Samsung is keen to sell a version of this arthritis treatment in Europe sometime early next year. The biosimilar version of Humira is pending approval by the European Medicines Agency (EMA). This ruling of the England and Wales High Court Chancery Division of the Patents Court, while determining that the two patents covering AbbVie’s Humira are invalid, also said that AbbVie's indications pertaining to rheumatoid arthritis, psoriasis and psoriatic arthritis were unpatentable. The other claimant in this case is Tokyo-based Fujifilm Kyowa Biologics. In 2015, Humira displaced Pfizer’s anti-cholesterol drug Lipitor by crossing US$ 14 billion in sales.

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09 Mar 2017

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Record fine levied on Pfizer for hiking drug price; US Senate clears biggest drug approval reform

This week, the US Senate cleared the 21st Century Cures bill, touted as the most significant reform in medical treatments. Phispers also brings you news on a court order that reverses a ban on 344 fixed-dose combination drugs in India, a shouting match between head honchos of pharma companies at a healthcare summit, a court order on J&J’s hip implant, and a warning letter to Interquim. US Senate clears Cures Act — the biggest reform on medical treatments On Wednesday, the US Senate passed the landmark 21st Century Cures Act. The bill had passed the House on November 30 and had advanced through the Senate earlier this week. After the vote, President Barack Obama said he would sign the measure “as soon as it reaches my desk.”The 21st Century Cures Act is a labyrinthine bill that would bring about significant changes in the way medical treatments are tested and brought to market over the coming decades. The legislation calls for the use of ‘data summaries’ to support the approval of certain drugs for new indications, rather than full clinical trial data. The Cures Act will also allow drug companies to promote off-label uses to insurance companies, allowing them to expand their markets.It includes ambitious goals to advance biomedical science, and will inject US $ 4.8 billion into a long-stagnating National Institute of Health budget.Critics call this deregulation, and a wolf in sheep’s clothing. They worry that both science and patients are going to suffer. They have argued the legislation is too friendly to Big Pharma, won’t curb high drug prices and may lead to unsafe treatments being put on the market. Tucked away in the 99-page bill are provisions that are likely to weaken the authority of the FDA as the bill includes language to put forward “real-world evidence” to support the approval of a new indication (or use) for an existing drug.Indian court quashes ban on fixed dose combination drugs As the 21st Century Cures Act will take us to an era of ‘inject and see’, the Indian government may want to see if the debate on banning fixed-dose combination (FDC) drugs can be resolved using ‘real-world evidence’. A government order banning 344 FDC drugs was overturned last week when the court was hearing a plea filed by pharmaceutical companies challenging the March 10, 2016 order which banned 344 FDC drugs. The ban included several common cough syrups, analgesics (pain killers) and anti-diabetes combinations.Pharmaceutical companies’ argued that the government’s action had been ad hoc in nature and is not aligned with the procedures mentioned under Section 26A of the Drugs and Cosmetics Act, 1940. They argued that the decision was taken without considering clinical data. And that it was based on an ‘absurd’ claim that there are safer alternatives available in the market today.Pfizer fined US $ 106.5 million in UK for hiking price of epilepsy drug The Competition and Markets Authority in the UK fined Pfizer a record US $ 106.5 million (GBP 84.2 million) for its role in increasing the cost of an epilepsy drug by a whopping 2,600 percent. The CMA also fined Flynn Pharma US $ 6.58 million (GBP 5.2 million) for overcharging for phenytoin sodium capsules.The ruling comes at a time when there is a growing debate both in the US and Europe about the ethics of price hikes for old off-patent medicines that have little competition.Pfizer used to market the (epilepsy) medicine under the brand name Epanutin, but sold the rights to Flynn, a privately owned British company, in September 2012. It was then debranded — i.e. it was no longer subject to price regulation — and the price soared.“The companies deliberately exploited the opportunity offered by debranding to hike up the price for a drug which is relied upon by many thousands of patients,” Philip Marsden, chairman of the CMA’s case decision group, said.“This is the highest fine the CMA has imposed and it sends out a clear message to the sector that we are determined to crack down on such behaviour,” Marsden addedPfizer, Regeneron CEOs get into a shouting match at healthcare summit At the Forbes Healthcare Summit held last week, a panel featuring Gilead CEO John Milligan, Pfizer CEO Ian Read, incoming Eli Lilly CEO David Ricks, Astellas Americas President Jim Robinson, and Regeneron CEO Leonard Schleifer were asked to contemplate on why the pharma industry isn't liked.While the panel discussed middlemen and adding value, Schleifer offered his own take.“I think you've just seen why our industry isn't liked. You've asked a question why we're not liked, we are a room full of people who are biased to like us, and nobody answered the question why we're not liked,” Schleifer said.“We dispelled of some of it last year, because we blamed it on the extremists, the people who come in, dial up a product that's off patent, raising price ten-fold and they're evil-doers, that's why we're not liked,” he continued. “But the real reason we're not liked, in my opinion, is because we as an industry have used price increases to cover up the gaps in innovation. That's just a fact.”Pfizer’s Read countered this with an often cited statistic that drug costs as a percentage of healthcare expenses haven’t changed in two decades, regardless of price increases.Schleifer’s response: “You’re not entitled to a fraction of the GDP.” What followed was a shouting match, until a member of the panel interjected. The pharma industry surely needs a unified message to send out to the world. Spain’s Interquim gets FDA warning letter for using dirty equipmentThe latest company to receive a warning letter from the FDA is Interquim SA of Spain. FDA investigators found the presence of residue in the interior surfaces of non-dedicated drug manufacturing equipment at Interquim that were labeled “clean.” Inadequate removal of residues from manufacturing equipment during cleaning can lead to cross-contamination of API subsequently manufactured, using the same equipment.Investigators also questioned the impact on API quality of the product produced from equipment whose interior surfaces were discolored even after an equipment maintenance contractor had previously noted the damage and repaired it.Interquim is a part of Ferrer, an international group of more than 50 companies with activities in the pharmaceutical, hospital, diagnostics, fine chemicals, feed and food sectors. Headquartered in Spain, its products are sold in more than 70 countries. It is a leading manufacturer of APIs like Celecoxib, Imiquimod, Paliperidone Palmitate, Rivaroxaban, Rivastigmine, etc. Explosion at excipient manufacturer in India claims two livesAn explosion at a manufacturer of pharmaceutical excipients — Nitika Pharmaceutical Specialities — in India claimed two lives and injured 19 others. While initial news reports claimed a boiler explosion, a report submitted by the inspector of boilers stated: “The explosion at M/s Nitika Pharmaceuticals Pvt Ltd is not a case of boiler explosion. There is no registered or exempted or unauthorized boiler in the unit. The heat requirement of the factory was being catered to by two thermic fluid heaters installed in the factory.”The local police arrested the company’s senior manager (operations), the senior manager (maintenance) and its managing director, who were later granted bail by the court. Cannabis cultivation to get boost due to upcoming approvalsGW Pharmaceuticals, a UK-based company focused on developing medicines from marijuana, plans to expand manufacturing in the UK and boost cultivation of the cannabis plants it uses to make a treatment for severe epilepsy.The British biotech firm is gearing up to submit Epidiolex — an experimental drug that has shown to be hugely effective in treating rare and life-threatening forms of childhood epilepsy —with US regulators in the first-half of 2017. Approval could come by early 2018.It was just last week that PharmaCompass covered the news of the medical cannabis sector managing to comply with pharmaceutical standards for inhalation. Israel’s Teva Pharmaceuticals has partnered with Tel Aviv-based Syqe Medical to market medical cannabis in Israel for pain management. Will Apple launch FDA regulated cardiac monitoring products soon?A collection of emails obtained by MobiHealthNews, through a Freedom of Information Act request to the FDA, indicates that since July 2016, Apple has been in discussions with the FDA about two FDA-regulated products in the cardiac monitoring space.In an interview with the Telegraph last year, Apple CEO Tim Cook had also hinted at a regulated medical device from Apple.“We don’t want to put the Watch through the Food and Drug Administration (FDA) process,” he said at the time. “I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it — maybe an app, maybe something else,” Cook had said. J&J to pay over US $1 billion in Pinnacle hip implants caseLast week, a federal jury in Dallas ordered Johnson & Johnson and its unit DePuy Orthopaedics to pay more than US $ 1 billion to six plaintiffs who said they were injured by the Pinnacle hip implants.According to the jurors, the metal-on-metal Pinnacle hip implants were defectively designed. And both companies failed to warn consumers about the risks. J&J and DePuy have been hit with nearly 8,400 lawsuits over the devices.However, verdicts of such size are often lowered by courts. In July, the judge presiding over this case reduced a US $ 500 million verdict in an earlier Pinnacle implant case to US $ 151 million by citing a Texas state law that limits punitive damages awards.

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08 Dec 2016

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The Next Generic Attack: Brilinta® (Ticagrelor), Xarelto® (Rivaroxaban), Tradjenta® (Linagliptin) and…

With almost 30,000 Drug Master Files (DMFs) submitted to the FDA, reviewing the filings of only the first quarter of 2015, provides an indicator on the current areas of focus of generic pharmaceutical companies. A detailed evaluation of the 241 filings for active pharmaceutical ingredients only, made us find some interesting trends worth sharing. European Blockbuster battle! Of the 241 DMFs, 21 APIs had more than one DMF filing and accounted for 25% of the total filings. Interestingly, 20 DMFs were for only three APIs: AstraZeneca’s blood thinner Brilinta® (Ticagrelor), with 2014 sales of $476 million, already had DMF filings from Dr. Reddy’s, Mylan, Polpharma and Zhejiang Hisun at the end of last year. With a maximum of 9 new filings from players like Teva, Alembic, Lek and others, AstraZeneca should brace itself for some serious generic onslaught. While the 9 filings for Ticagrelor were the most for any single compound, not far behind is Bayer’s own blood thinner: Xarelto® (Rivaroxaban). With 7 submissions, the focus of the generic companies is understandable as Rivaroxaban had sales in excess of $3 billion and year-on-year growth in excess of 70%. However, patents currently protect the product till 2020, so patience is needed before generics can access this golden opportunity. Interestingly, 4 filings for Linagliptin (Boehringer’s antidiabetic Tradjenta®) make it yet another European pharma giant lead the list of products being subjected to generic competition, and make us wonder why European blockbusters are preferred over others? Exclusive but not patented There are products, which have no patent protection, but the market is protected by FDA granted exclusivities (learn more on patents and exclusivities from the FDA website). An opportunity for generic companies to gain significant market share of a multi-hundred million dollar market, without any litigation risk or cost is something companies dream about. As the time of exclusivity expiry nears, Clobazam, Tetrabenazine, Hydroxyprogesterone Caproate, Deferiprone and Trypan Blue will all see increased generic activity as their Drug Master Files have been submitted. Fragmented Activity More than 80% of the DMF submissions were made by companies who filed only a single product. While the products varied from simple compounds like Sodium Chloride to biologics like Plasmid DNA, over 140 companies filed DMFs in the first quarter with almost 30 submitting a DMF for the first time. An expanding list of suppliers who support DMFs increases options for sourcing managers. However, a fragmented supplier base limits the industrial scale companies can achieve and raises concerns regarding how many can successfully sustain compliance standards under increased regulatory scrutiny? The Next Generic Wave Blood thinners are an opportunity few generic companies wish to pass on. Boehringer’s (Dabigatran Etexilate), Bristol-Myers Squibb’s (Apixaban) and Bayer’s (Rivaroxaban) are novel compounds in this category which had combined sales in excess of $5 billion last year. While Dagibatran saw a flurry of activity over the last two years with almost 15 DMF filings, there were no additional filings this year. On the other hand, Apixaban, which generated $774 million for Bristol-Myers Squibb in 2014, has only one DMF filing at the moment and that too was done over a year ago. The export data out of India, reviewed on PharmaCompass, for Apixaban, indicates that product development is already complete so it is just a matter of time before the filings begin. Conclusion: Product and supplier selection is a critical component of every generic company’s strategy. The PharmaCompass database is designed to assist professionals in business development, marketing and sourcing to take more informed decisions. If you would like us to share our shortlist of 241 DMFs, we will be happy to send it to you by email (click here). You can also access our compilation of the 2014 annual reports of major pharmaceutical companies to review the various products along with their revenues (click here): Table: Products with more than one DMF filing in Q1 2015 PRODUCT NAME DMF FILINGS TICAGRELOR 9 RIVAROXABAN 7 LINAGLIPTIN 4 APREPITANT 3 CINACALCET HYDROCHLORIDE 3 ATAZANAVIR SULFATE 2 ATORVASTATIN CALCIUM TRIHYDRATE 2 CLOBAZAM 2 CLOFARABINE 2 DEFERASIROX 2 DIMETHYL FUMARATE 2 EZETIMIBE 2 ICATIBANT ACETATE 2 LURASIDONE HYDROCHLORIDE 2 MELPHALAN HYDROCHLORIDE 2 OLANZAPINE 2 OLMESARTAN MEDOXOMIL USP 2 PRASUGREL HYDROCHLORIDE 2 RIVASTIGMINE USP 2 ROSUVASTATIN CALCIUM 2 SOLIFENACINE SUCCINATE 2

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13 May 2015

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Dr. Reddy’s expansion plans for API production

Unrelated to the inspection of the USFDA at the Dr. Reddys Srikakulam facility, Dr. Reddys sought permission from the Ministry of Environment, Forests & Climate Change to expand their drug and intermediate manufacturing at three locations. All three chemical technical operation (CTO) units, CTO-I, CTO-II & CTO-III are located in Medak district and the announced planned capacity increases along with the anticipated capital investment were Existing Capacity Planned Capacity Anticipated Investment CTO I 14.7 TPM 45.5 TPM Rs 30 crores CTO II 21.9 TPM 68.9 TPM Rs 45 crores CTO - III 4.45 TPM 28.1 TPM Rs 12 crores *$1 million is approximately about Rs 6.2 crores & TPM is tons per month In addition, the declaration given by Dr. Reddys also mentions the various products which will be produced at each facility (table below). Needless to say, the plans are ambitious however with the growth witnessed by the Indian pharmaceutical industry over the past decade, one can understand Dr. Reddys commitment to investing further in their business. Table Dr. Reddys production plans at various facilities Product Name Planned Capacity (TPM) Facility Location Alendronate Sodium Trihydrate 6.67 CTO - III Alfuzosin 2.33 CTO - I Altretamine 0.03 CTO - I Amlodipine Besylate 33.33 CTO - II Amlodipine Besylate 133.33 CTO - III Amlodipine Besylate ( Ethyl 4 [2- (pthalamide)ethoxy] aceto acetate (TDM-2) 100 CTO - II Amlodipine Maleate 30 CTO - III Amsacrine 0.07 CTO - I Anastrazole 0.83 CTO - II Aprepitant 3.33 CTO - III Aripiprazole 0.33 CTO - II Atomoxetine 1.67 CTO - III Atorvastatin 375.83 CTO - II Azacitidine 0.67 CTO - I Bicalutamide 0.03 CTO - II Bivalirudin 0.03 CTO - II Bivalirudin Trifluoro Acetate 0.03 CTO - I Bortezomib 0.03 CTO - I Cabazitaxel 0.02 CTO - I Candesartan cilexetil 6.67 CTO - II Cetirizine Hydrochloride 66.67 CTO - I Cetirizine 16.67 CTO - II Ciprofloxacin 176.67 CTO - II Ciprofloxacin HCl 533.33 CTO - II Ciprofloxacin Lactate 33.33 CTO - II Clopidogrel Bisulfate 500 CTO - I Clopidogrel Premix 166.67 CTO - II Diluted Everolimus 5% (Everolimus) 0.33 CTO - II Disodium Pamidronate 0.33 CTO - III Docetaxel 1.9 CTO - I Dutasteride 3.33 CTO - II Esomeprazole magnesium 66.67 CTO - III Ezetimibe 3.33 CTO - II Fexofenadine Hydrochloride 500 CTO - I Finasteride 10 CTO - II Fluoxetine 110 CTO - I Fondaparinux Sodium 0.33 CTO - II Galantamine 0.03 CTO - II Gemcitabine 13.33 CTO - I Glimepiride 13.33 CTO - II Imatinib 0.17 CTO - I Irinotecan 0.33 CTO - I Ketorolac 66.67 CTO - II Lacidipine 5 CTO - III Lamotrigine 33.33 CTO - I Lansoprozole 8.33 CTO - III Letrozole 0.03 CTO - II Levocetrizine Di HCl 10 CTO - III Levofloxacin 200 CTO - II Lomustine 1.33 CTO - I Losartan Postassium 150 CTO - I Meloxicam 0.03 CTO - I Memantine HCl 3.33 CTO - II Mesalamine 0.03 CTO - II Metoprolol Succinate 266.67 CTO - II Moxifloxacin 116.67 CTO - II Norfloxacin 0.03 CTO - I Omeprazole 133.33 CTO - III Omeprazole Magnesium 50 CTO - III Omeprazole Sodium 10 CTO - III Omerprazole Form B 33.33 CTO - III Paclitaxel 0.33 CTO - I Pantoprazole Sodium 100 CTO - III paroxetine HCl 0.03 CTO - II Pemetrexed 0.67 CTO - I Rabeprazole Sodium 83.33 CTO - III Raloxifene 33.33 CTO - II Ramipril 100 CTO - III Repaglinide 6.67 CTO - II Rivastigmine 6.67 CTO - II Risperidone 13.33 CTO - I Rivastigmine 6.667 CTO - I Rizatriptan Benzoate 1.33 CTO - II Rocuronium Bromide 0.03 CTO - II Ropinrole HCl 1.83 CTO - III Rosiglitazone 3.33 CTO - II Sparfloxacin 3.33 CTO - I Tacrolimus 5 CTO - II Tadalafil 3.33 CTO - II Telmisartan 100 CTO - II Temozolamide 0.03 CTO - I Terbinafine HCl 133.33 CTO - III Tizanidine HCl 16.67 CTO - III Topotecan 0.07 CTO - I valganciclovir 0.03 CTO - I Vardenafil 3.33 CTO - II Voriconazole 8.33 CTO - III Ziprasidone Hydrochloride 100 CTO - I Zoledronic acid 0.33 CTO - III Zolmitriptan 0.83 CTO - I Zonisamide 0.03 CTO - II

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03 Apr 2015

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Dr. Reddy’s expansion plans for API production

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