Dabigatran Etexilate

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

95 API Suppliers, 36 USDMF, 20 EU WC, 19 KDMF, 22 NDC API, 75 Listed Suppliers

DEVELOPMENTS

3 Drug(s) in Development

3 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

INTERMEDIATES

97 Suppliers

97 Suppliers

DOSSIERs // Finished Dosage Formulations

126 Dossiers, 34 FDA Orange Book, 29 Europe, 6 Canada, 21 Australia, 5 South Africa, 31 Listed Dossiers

DRUG PRODUCT COMPOSITION

CAPSULE;ORAL - EQ 110MG BASE, CAPSULE;ORAL - EQ 150MG BASE, CAPSULE;ORAL - EQ 75MG BASE

CAPSULE;ORAL - EQ 110MG BASE
CAPSULE;ORAL - EQ 150MG BASE
CAPSULE;ORAL - EQ 75MG BASE

RELATED EXCIPIENT COMPANIES

Suppliers, 12 Kerry, 10 Corel Pharma Chem, 7 Seppic, 6 Lonza Capsugel, 4 Ideal Cures Pvt Ltd, 3 Gangwal Chemicals, 3 Kima Chemical, 3 Roquette, 2 Microlex e.U, 2 Rochem International Inc, 2 Finar, 2 SPI Pharma, 2 The Dow Chemical Company, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 ACG Worldwide, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Sigachi Industries, 1 Aeon Procare, 1 BASF, 1 Nanjing Well Pharmaceutical, 1 Gangwal Healthcare, 1 DKSH

EXCIPIENTS BY APPLICATIONS

41 Coating Systems & Additives, 19 Controlled & Modified Release, 9 Film Formers & Plasticizers, 7 Fillers, Diluents & Binders, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Parenteral, 3 Solubilizers, 3 Direct Compression, 3 Emulsifying Agents, 3 Thickeners and Stabilizers, 2 Lubricants & Glidants, 2 Disintegrants & Superdisintegrants, 2 Granulation, 2 Taste Masking, 2 Coloring Agents, 2 Topical, 1 Chewable & Orodispersible Aids, 1 Co-Processed Excipients, 1 Soft Gelatin, 1 Rheology Modifiers

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 28 Finished Drug Prices

MARKET PLACE

13 APIs, 4 DOSSIERS // FDF

PATENTS

26 US Patents, 18 US Exclusivities

ANALYTICAL SOLUTION(s)

1 Other Ref. Standards

1 Other Ref. Standards

DIGITAL CONTENT

4 Data Compilations & Company Tracker #PharmaFlow, 74 News

Blog

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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)

Impressions: 54757

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#PharmaFlow by PHARMACOMPASS

29 Apr 2020

Chemical entities SHINE in the top 10 fastest-growing drugs of 2016

Global pharmaceutical companies are increasingly focusing on the development of new biologics. In fact, in 2016, nine out of the top 15 pharmaceutical drugs by sales were of biologic origin. This makes us wonder what the future holds for manufacturers specializing in drugs that originate from chemical synthesis. This week, PharmaCompass continued its analysis of the top pharma drugs by sales to evaluate the drugs that registered large sales growth in 2016. Click here to Access All the 2016 Data (Excel version available) for FREE! Please note that these are not the top-selling drugs, but are the top 10 drugs that registered the maximum growth in global sales over 2015. Interestingly, things didn’t appear that bad for drugs originating from chemical synthesis — while the top two drugs on the list were biologics, the remaining originated from chemical synthesis. Here’s a list of drugs that witnessed the largest sales growth in 2016: 1. Opdivo (nivolumab) – Bristol-Myers Squibb 2016 sales: US$ 3,774 million 2015 sales: US$ 942 million Sales growth: US$ 2,832 million First approved in 2014, Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda — also known as checkpoint inhibitors — continued to stay on track to be among the top 20 best-selling drugs in the world by 2020. They represent the hot new field of immunotherapy and are known to have given 90-year old Jimmy Carter (former President of the United States) hope in his fight against cancer. With a sales growth of US$ 2.832 billion, Opdivo registered the highest sales growth of any single drug in 2016. However, Bristol-Myers Squibb received a nasty surprise last year when Opdivo did not demonstrate the desired slowdown in the progress of advanced lung cancer in a trial, as compared to conventional chemotherapy. While Bristol-Myers’ stock price plunged on this news, Merck announced that not only did Keytruda succeed in a clinical trial as an initial treatment for advanced non-small cell lung cancer, but patients actually lived longer. Although Keytruda did not make it to our list of top 10 drugs by sales growth in 2016, it did register a sales increase of US$ 836 million, as its sales grew from US$ 566 million to US$ 1,402 million. Click here to Access All the 2016 Data (Excel version available) for FREE! 2. Humira (adalimumab) – AbbVie 2016 sales: US$ 16,078 million 2015 sales: US$ 14,012 million Sales growth: US$ 2,066 million Abbvie’s Humira (adalimumab) juggernaut continued as it not only remained the best-selling drug in the world, but also added another US$ 2 billion to its 2015 sales by generating record sales of US $16.078 billion in 2016. Last year, the US Food and Drug Administration (FDA) approved Amgen’s Amjevita™ (adalimumab – atto) — a biosimilar of Humira®. Therefore, it remains to be seen if Humira will be able to sustain the momentum. Amjevita was approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis. 3. Epclusa (sofosbuvir and velpatasvir) – Gilead 2016 sales: US$ 1,752 million (new launch) Gilead’s third sofosbuvir-based regimen — Epclusa (sofosbuvir and velpatasvir) was approved by the US FDA in June 2016. It is the first and only all-oral, pan-genotypic single tablet regimen for chronic Hepatitis C virus infection. While Epclusa registered an impressive start, Gilead's other two sofosbuvir-based treatments — Sovaldi (sofosbuvir) and Harvoni (sofosbuvir and lepidasvir) — saw their combined sales decline by almost US$ 6 billion. Click here to Access All the 2016 Data (Excel version available) for FREE! 4. Imbruvica (ibrutinib) — Johnson & Johnson / AbbVie 2016 sales: US$ 3,083 million 2015 sales: US$ 1,443 million Sales growth: US$ 1,640 million Abbvie’s 2015 US$ 21 billion buy of Pharmacyclics seems to be paying off. The Pharmacyclics buy was a way to get access to Imbruvica (ibrutinib), a cancer drug which is co-marketed with Johnson & Johnson. It generated sales of US$ 3.083 billion in 2016. Imbruvica works by blocking a specific protein called Bruton’s tyrosine kinase (BTK). In December 2011, Johnson & Johnson said it would pay Pharmacyclics as much as US$ 975 million to fund getting the drug to market in exchange for half the profits generated globally. 5. Eliquis (apixaban) - Bristol-Myers Squibb / Pfizer 2016 sales: US$ 3,342 million 2015 sales: US$ 1,860 million Sales growth: US$ 1,483 million Although apixaban was the third-to-market novel oral anticoagulant (NOAC), which is co-promoted by Pfizer and Bristol-Myers Squibb as Eliquis, it continues to unseat Johnson & Johnson’s Xarelto (rivaroxaban) as the leader in its class based on total prescriptions. Rivaroxaban's total 2016 sales were US$ 5.392 billion. While Pfizer’s reports its sales as part of Alliance revenues, and exact sales are not known, Bristol-Myers Squibb results alone put Eliquis in the top 10 list. Generics are hot on their tail as, last month, Pfizer and Bristol-Myers’ filed suits against 16 generic makers to uphold their patents for apixaban. 6. Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) — Gilead 2016 sales: US$ 1,484 million 2015 sales: US$ 45 million Sales growth: US$ 1,439 million Genvoya has been the most successful HIV treatment launch since the introduction of Atripla (the first single-tablet regimen launched a decade ago). Gilead is the dominant HIV player in the US market and has the top three most-prescribed HIV regimens in the US. Genvoya adds Tenofovir Alafenamide (TAF) to already known treatments. TAF based drugs have demonstrated a better safety profile. They would also allow Gilead to maintain its dominance in the HIV market. Click here to Access All the 2016 Data (Excel version available) for FREE! 7. Ibrance (palbociclib) — Pfizer 2016 sales: US$ 2,135 million 2015 sales: US$ 723 million Sales growth: US$ 1,412 million Discovered in Pfizer laboratories and approved by the US FDA in February 2015, Ibrance is used in combination with Letrozole as a first-line treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer. 8. Triumeq (abacavir, dolutegravir, lamivudine) – GlaxoSmithKline 2016 sales:US$ 2,151 million 2015 sales: US$ 905 million Sales growth: US$ 1,246 million GlaxoSmithKline's HIV drugs business — ViiV Healthcare — has been enjoying sales growth with the introduction of Triumeq ® in its portfolio. While GSK is the major shareholder in ViiV Healthcare, Pfizer and Shionogi also have a stake. Triumeq® is the company’s first fixed-dose combination tablet for a once-daily single pill regimen that combines dolutegravir, an integrase inhibitor, with the nucleoside reverse transcriptase inhibitors — abacavir and lamivudine. 9. Revlimid (lenalidomide) – Celgene 2016 sales: US$ 6,974 million 2015 sales: US$ 5,801 million Sales growth: US$ 1,173 million Celgene’s Revlimid (lenalidomide) — a thalidomide-derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in US$ 5.8 billion in 2015, and grew another 20 percent this year, to US $6.974 billion. Revlimid now contributes more than 60 percent to Celgene's total sales of US$ 11.229 billion. 10. Xarelto (rivaroxaban) – Johnson & Johnson (US) and Bayer 2016 sales: US$ 5,392 million 2015 sales: US$ 4,255 million Sales growth: US$ 1,137 million Bayer’s Xarelto, which is promoted by Johnson & Johnson in the United States, provided patients with an alternative to the old-guard therapy — warfarin. While rivaroxaban is competing with other novel oral anticoagulants (NOAC) like Eliquis (apixaban) and Pradaxa (dabigatran), rivaroxaban has the class lead in indications. Xarelto recently posted positive results in a large-scale Phase 3 study —COMPASS, involving 27,402 patients, that assessed the effect of the blood thinner in preventing major adverse cardiac events (MACE). The trial was stopped a year early on the advice of an independent Data Monitoring Committee, after the primary endpoint of prevention of MACE (which includes cardiovascular death, myocardial infarction and stroke) reached its pre-specified criteria for superiority over aspirin. Click here to Access All the 2016 Data (Excel version available) for FREE! Our view In QuintilesIMS Institute’s new annual drug spending report, analysts have forecasted that over the coming five years the industry should continue to receive 40 to 45 new drug approvals every year. A quarter of all the drugs in late-stage development are now focused on oncology. The rate of oncology drug development has hit such a rapid pace that new drugs are superseding old ones in a matter of a few years. It’s clear that this compilation will see radical changes next year. However, with eight out of the 10 fastest-selling drugs coming from chemical synthesis, traditional generic manufacturers still have a lot of opportunities to explore. Sign up, stay ahead In order to stay informed, and receive industry updates along with our data compilations, do sign up for the PharmaCompass Newsletter and you will receive updated information as it becomes available along with a lot more industry analysis. Click here to Access All the 2016 Data (Excel version available) for FREE!

Impressions: 9289

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#Phispers by PHARMACOMPASS

17 May 2017

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

Impressions: 8784

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13 May 2015

Fondaparinux –An Opportunity Worth Developing

A recent study published in the Journal of the American Medical Association (JAMA) showed that patients who received the anticoagulant fondaparinux (Arixtra®) and had experienced a certain type of heart attack had a lower risk of major bleeding events and death, both in the hospital and after six months, compared to patients who received low-molecular-weight heparin (LMWH). The authors analyzed data from a Swedish registry, which included 40,616 patients who had experienced an NSTEMI (non-ST-segment elevation myocardial infarction). A certain pattern on an electrocardiogram following the heart attack was observed, and 14,791 patients (36.4 percent) received fondaparinux, while 25,825 (63.6 percent) received LMWH. Fondaparinux, an injectable blood thinner that fights clots in the legs (deep vein thrombosis – DVT) and lungs (pulmonary embolism – PE), is a synthetic pentasaccharide, which is difficult to manufacture on a commercial scale. Arixtra belonged to GSK as recently as 2013, when it was sold off to the South African company Aspen Global Incorporated. Due to Aspen’s lack of a sales representative in the US, they were forced to enter into a $300 million agreement with Mylan for the US market, through which Mylan would pay Aspen $225 million upon completion of the transaction, and an additional $75 million would be held in escrow until certain conditions were met. Apotex had previously been given the rights to sell the authorized generic of Arixtra, the rights of which would eventually transfer to Mylan, which was scheduled to occur by the end of 2014. Arixtra and the authorized generic of Arixtra had US sales of approximately $18.8 million and $95.3 million, respectively, for the 12 months ending on June 30, 2014, according to IMS Health. Currently, the only approved product on the US market, other than Mylan’s, is that of Dr. Reddy’s, which was approved in 2011. Dr. Reddy’s entered into a partnership with the Australian company Alchemia, who claims to have been granted patents over novel synthetic pathways that prevent others from using Alchemia’s proprietary process to manufacture fondaparinux until at least 2022. The regulatory filing review on PharmaCompass shows two suppliers of the key intermediates who have submitted USDMFs, along with multiple API DMF fillings indicating increased availability of the drug substance. This should overcome a major barrier to entry into the Fondaparinux business. What makes us believers in Fondaparinux? Here are some facts: $150 million – This is the size of the market in the United States alone. There are only 2 approved US marketing authorization holders (Mylan and Dr. Reddy’s). There are alternative API supply sources emerging other than Aspen (through Sanofi’s Sisteron site and Alchemia). Blood thinners are a booming opportunity. Pfizer’s Eliquis, Bayer’s Xarelto, and Boehringer Ingelheim’s Pradaxa are all expected to achieve sales of more than $1 billion each. There has been limited development activity in India as demonstrated by the trade data. The high development costs will keep this market niche in the long run. The recently published study data is extremely positive and will increase sales.

Impressions: 5024

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#Phispers by PHARMACOMPASS

11 Mar 2015

Find PharmaFlow Article for Dabigatran Etexilate

Dabigatran Etexilate

Dabigatran Etexilate

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

95 API Suppliers

36 USDMF

20 EU WC

19 KDMF

22 NDC API

75 Listed Suppliers

DEVELOPMENTS

3 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

97 Suppliers

DOSSIERs // Finished Dosage Formulations

126 Dossiers

34 FDA Orange Book

29 Europe

6 Canada

21 Australia

5 South Africa

31 Listed Dossiers

DRUG PRODUCT COMPOSITION

CAPSULE;ORAL - EQ 110MG BASE

CAPSULE;ORAL - EQ 150MG BASE

CAPSULE;ORAL - EQ 75MG BASE

RELATED EXCIPIENT COMPANIES

Suppliers

12 Kerry

10 Corel Pharma Chem

7 Seppic

6 Lonza Capsugel

4 Ideal Cures Pvt Ltd

3 Gangwal Chemicals

3 Kima Chemical

3 Roquette

2 Microlex e.U

2 Rochem International Inc

2 Finar

2 SPI Pharma

2 The Dow Chemical Company

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 ACG Worldwide

1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Sigachi Industries

1 Aeon Procare

1 BASF

1 Nanjing Well Pharmaceutical

1 Gangwal Healthcare

1 DKSH

EXCIPIENTS BY APPLICATIONS

41 Coating Systems & Additives

19 Controlled & Modified Release

9 Film Formers & Plasticizers

7 Fillers, Diluents & Binders

5 Empty Capsules

4 Vegetarian Capsules

4 API Stability Enhancers

3 Parenteral

3 Solubilizers

3 Direct Compression

3 Emulsifying Agents

3 Thickeners and Stabilizers

2 Lubricants & Glidants

2 Disintegrants & Superdisintegrants

2 Granulation

2 Taste Masking

2 Coloring Agents

2 Topical

1 Chewable & Orodispersible Aids