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Mid 2018 – Recap of Warning Letters, Import Alerts and Non-Compliances

In our mid-2018 compliance review, we look at inspection challenges faced by companies across the world. In the first half of this year, manufacturing compliance challenges dominated headlines. But we also saw shortcomings at major pharmaceutical companies like Pfizer, Bayer and Akorn generate news. While China, India and the US continued to be the top three countries where regulators uncovered compliance issues, this year has also seen the FDA take action against many South Korean companies. The European authorities found concerns in India, Taiwan, Italy and Spain. However, there were no non-compliance reports issued to firms in China until the end of June 2018. While data-integrity violations and a failure to thoroughly investigate deviations continued to remain a major concern for inspectors, this year the real concern emanated from the supply of product to market (which had the potential to impact product quality or patient safety). Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! China: API with a cancerous impurity, vaccine scandal and data-integrity woes The most recent regulatory non-compliance issue pertains to the European Medicines Agency (EMA) raising concern over the active pharmaceutical ingredient (API) valsartan supplied by China’s Zhejiang Huahai Pharmaceuticals. The concern was the impurity — nitrosodimethylamine (or NDMA) — detected by the company in their valsartan API. NDMA is classified as a probable human carcinogen and its presence was unexpected as it was not detected by routine tests carried out by Zhejiang Huahai. Zhejiang Huahai sold over US$ 50 million of the API in 2017 and supplies to most major manufacturers producing valsartan medicines available in the EU and United States. While a review is underway, national authorities across the EU, US and Asia are recalling medicines containing valsartan supplied by Zhejiang Huahai. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! Vaccine scandal: A major vaccination scandal has sparked off a huge outcry in China as vaccine maker Changsheng Biotechnology was found to have falsified production data for its rabies vaccine. Changchun Changsheng Bio-tech Co, in Changchun, reported serious irregularities, including fabricating production records in the manufacture of rabies vaccines for human use, during an inspection by the State Drug Administration, China FDA said in a statement. Although there has been no evidence of harm from the vaccine, the firm has been ordered to halt production and recall rabies vaccines. And Chinese Premier Li Keqiang has urged severe punishment for the people involved, saying the incident had “crossed a moral line”. Data-integrity violations: This year, the FDA also posted the warning letter issued to Henan Lihua Pharmaceutical in China, a company that produces steroid APIs like hydrocortisone and prednisone. The warning letter highlighted data integrity concerns that landed Henan on FDA’s import alert list in March 2018. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! During the inspection, the FDA investigator observed numerous blank batch manufacturing records in an open cabinet in the firm’s manufacturing workshop office. Among these was multiple blank, product release forms marked with a red quality assurance release stamp stating ‘Permitted to Leave [the] Factory’. The FDA also posted a warning letter issued to Jilin Shulan Synthetic Pharmaceutical, a manufacturer of caffeine API in China. The letter revealed flagrant data-integrity violations. Another warning letter was issued by the FDA to API manufacturer Lijiang Yinghua Biochemical and Pharmaceutical, following an October 2017 inspection. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! United States: Drug shortages due to Pfizer’s manufacturing problems Drug major Pfizer’s production problems continued to make headlines this year. An article in Fortune put the blame on Pfizer’s much-touted US$ 17 billion acquisition of Hospira in 2015 for turning the United States’ chronic drug shortage into a full-blown crisis. According to the article, as of May 11 this year, Pfizer — which is the world’s largest maker of sterile injectable drugs — had 370 products that are depleted or in limited supply, 102 of which the company has indicated will not be available until 2019. “The simple answer to why America currently has so many shortages of generic sterile injectable drugs: America’s leading manufacturer of generic sterile injectable drugs hasn’t been making them,” the article said. Mylan’s flagship product EpiPen is also likely to face shortages due to problems at Pfizer. Although Mylan owns the rights to the EpiPen, it subcontracts manufacturing of the auto-injector to Meridian Medical Technologies, a division of Pfizer. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! While Mylan is putting pressure on Pfizer to do more to tackle shortages of this life-saving medicine, Pfizer has struggled to meet demand for the EpiPen and the FDA had put the medicine on its official shortages list. In September last year, the FDA had issued a warning letter to Meridian Medical Technologies over serious component and product failures that had been associated with patient deaths. Pfizer’s troubles are far from over as an FDA inspection of an ex-Hospira sterile manufacturing facility in India resulted in the issuance of a 32 page Form 483. The same facility was issued a warning letter by the FDA in 2013. Germany: FDA highlights contamination, data-integrity concerns at Bayer facility In a shocking warning letter issued by the FDA to Bayer Pharma’s finished pharmaceuticals manufacturing facility located in Leverkusen, Germany, investigators found compliance shortcomings ranging from concerns over data-integrity to serious product contamination problems. While reviewing a drug product manufacturing operation, FDA investigators found residue on equipment which seemed most likely from a drug product that had been previously processed in the same room. When Bayer tested the samples of the tablets being produced to “assess the potential of cross-contamination”, the testing confirmed contamination of the previously processed product inside the tablets which resulted in a recall of several lots of drug products. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! Before the FDA inspection, Bayer had started its own data-remediation program to discontinue the practice of using “test” injections during testing. However, when the FDA investigators performed their own inspection, they found unreported data from in-process tablet weight checks. Bayer’s staff had programmed their in-process weight checker not to report values that varied more than a specified amount from the tablet target weight. The inspection was held between January 12 and 20, 2017, and responses submitted to the FDA in May and August 2017 failed to address the concerns of the agency. Fresenius aborted US$ 4.3 billion takeover of Akorn: ‘Blatant fraud’ or buyer’s remorse? This year also saw German healthcare group Fresenius abandon its US$ 4.3 billion takeover of US generic drugmaker Akorn over data-integrity concerns. Illinois-based Akorn filed a lawsuit in the Delaware Chancery Court asking that Fresenius be required to “fulfill its obligations” under the buyout agreement. In a court filing made public, Fresenius alleged that its investigation uncovered “blatant fraud at the very top level of Akorn’s executive team, stunning evidence of blatant and pervasive data integrity violations.” Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! Akorn’s lawsuit acknowledged it investigated the possible submission of falsified data and fired an executive who was involved. Fresenius claims the executive involved in the fraud wasn’t fired. Instead, he was suspended and given a consulting position with a US$ 250,000 salary. The executive, whose name is redacted from the court filings, stands to receive a payout if the merger is consummated. The most significant instance of a data integrity issue involves an ANDA for the drug product azithromycin that was pending with the FDA, which Akorn had submitted on December 21, 2012. The court will decide if the data-integrity concerns are truly legitimate or being blown out of proportion by Fresenius, who may be suffering from buyer’s remorse and wants to exit the deal. The court agreed to put Akorn’s case on fast track and the trial is currently underway. South Korea: Teva’s potential blockbuster gets delayed due to problems at Celltrion As Korea emerges as a force to reckon with in the emerging world of biosimilars, the USFDA's issuance of a warning letter to Celltrion (a major manufacturer of biosimilars that has also partnered with Pfizer for commercialization in the United States) came as a major setback. In an inspection conducted by the FDA from May 22 to June 2, 2017, the investigators raised concerns over multiple poor aseptic practices during the set-up and filling operations. The warning letter highlights an example where during the aseptic filling of vials, an operator used restricted access barrier system (RABS) to remove a jammed stopper by reaching over exposed sterile stoppers in the stopper bowl. The RABS disrupted the unidirectional airflow over the stopper bowl, creating a risk for microbial contamination. After the operator removed the jammed stopper, the filling line was restarted, but the affected stoppers were not cleared. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! At Celltrion, the FDA raised concern over 140 complaints received between October 2015 to May 2017, which were identified to have occurred because of vial stoppers. The deficiencies at Celltrion impacted Teva as the Korean company is the main API supplier for Teva’s migraine drug fremanezumab. Teva confirmed that the USFDA had extended the goal date of the Biologics License Application (BLA) for fremanezumab. The Prescription Drug User Fee Act (PDUFA) action date for fremanezumab is currently set for September 16, 2018. The Celltrion warning letter was followed by an announcement by the US-based Evolus that a USFDA pre-approval inspection of Daewoong Pharmaceutical’s plant in South Korea, where a botox biosimilar is being produced, resulted in 10 observations. Back in 2013, Daewoong had inked a contract with Evolus to export DWP-450 (a botulinum neurotoxin candidate), which was expected to be released in the US market around 2017-18. While Daewoong said it expects “no significant further actions”, Evolus’ SEC filing highlights that “any failure to adequately resolve the FDA’s observations at the Daewoong facility would likely cause FDA approval of DWP-450 to be delayed or denied”. In May, the FDA declined to approve Evolus’ Botox rival citing deficiencies related to the chemistry and manufacturing of its potential treatment for frown lines. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! India: Data-integrity violations, invalidation of OOS results continue Alkem has ‘no quality control unit’: After eight days of inspecting Alkem Laboratories’ finished formulation facility in India in March 2018, the FDA investigators concluded — “there is no quality control unit”. Alkem’s head of quality control (QC) and quality assurance (QA) confirmed out-of-specification (OOS) results for the assay for a batch of tablets. However, the company did not recall the product, which was distributed in the US market. Less than three weeks before the inspection, the “firm’s QC department deleted two-thousand one hundred one (2,101) files” on its computer network. Alembic invalidated OOS results: In the seven days that the FDA investigator — Jessica L Pressley — spent at Alembic Pharmaceuticals’ oral solid dosage manufacturing facility in Tajpura, Gujarat, she uncovered that the firm invalidated 131 of the 140 OOS results (an invalidation rate of 94 percent) for products marketed in the US. The firm attributed the invalidation to analyst errors. In 2017, the invalidation rate was 91 percent. The Form 483 shares a concern that the “OOS results that were invalidated by the firm’s QC unit were without rationale and supporting documentation.” Alchymars falsified lab data: A September 2017 inspection by the USFDA at Alchymars ICM SM Private Limited in India uncovered that the firm “was falsifying laboratory data”. During the inspection, the FDA investigator found that an analyst reported far fewer colony-forming units (CFU) in a water sample than those observed on the plate by the investigator. The FDA raised serious concerns as Alchymars uses the water to manufacture APIs intended for use in sterile injectable dosage form drug products. Alchymars is part of a group of companies and the factory is controlled by Trifarma in Italy, a company which was cited by the FDA for data-integrity violations in 2014. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE! Our view This year, concerns over pharmaceutical manufacturing spread beyond China, India and the United States as data integrity issues also emerged in Japan and Australia. In Taiwan, the failure to establish an adequate system for monitoring environmental conditions in aseptic processing areas was a problem uncovered by both the FDA and EU inspectors. A firm in France released an over-the-counter (OTC) drug product without testing if the active ingredients conformed to specifications. PharmaCompass’ review of the observations indicates that as inspectors start adopting a more standardized approach towards inspections, the problems they uncover across countries are along similar lines. At PharmaCompass, we believe that a review of our Mid-Year Non-Compliances in 2018 will provide you with the insights necessary to prepare and insulate your business from the concerns raised during regulatory inspections. Click here to access all Mid-Year Non-Compliances in 2018 (Excel version) for FREE!

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26 Jul 2018

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Sanofi lawsuit highlights Mylan’s unfair trade practices; Fresenius goes on multi-billion dollar spending spree

This week, Phispers brings you an update on M&As in the drug and medical equipment industry, along with verdicts of lawsuits against GSK and Mylan. There is also news on Samsung Bioepis’ biosimilar —Renflexis; a directive from the Medical Council of India for doctors to prescribe generics; and news that Marathon may soon wind up. Read on. M&A update: Fresenius buys Akorn; Becton Dickinson to acquire C R Bard Fresenius Kabi-Akorn: Fresenius Kabi is buying US-based manufacturer and marketer of prescription and over-the-counter drugs — Akorn — for around US $ 4.3 billion, or US $ 34.00 a share. Kabi will also assume approximately US $ 450 million of Akorn’s debt. The transaction, which is likely to close by early 2018, has the support of Akorn's largest shareholder, who controls approximately 25 percent of its shares. Akorn is a specialty generic pharmaceutical company engaged in the development, manufacture and marketing of multi-source and branded pharmaceuticals. Sawai to buy Upsher Smith: A leading generics manufacturer in Japan — Sawai Pharmaceutical — and US-based generics manufacturer — Upsher-Smith Laboratories — announced an agreement whereby Sawai will buy the generic pharmaceuticals business of Upsher-Smith, from its parent — Acova for $ 1.05 billion. Upsher-Smith is a privately held drug company, based in Minnesota. It’s owned by the Evenstad family through their company, Acova. It has a diversified product portfolio of over 30 pharmaceutical products. Becton Dickinson to acquire C R Bard: Becton Dickinson and Co, a medical equipment supplier, will acquire C R Bard Inc in a US $24 billion cash-and-stock deal. This way, Becton Dickson will add Bard's devices to its portfolio in the high-growth sectors of oncology and surgery. This is the latest in a string of deals in the medical technology sector. Two years ago, Becton Dickinson had acquired CareFusion Corp for US $ 12 billion. This acquisition will strengthen Becton Dickinson’s position in the markets for catheters, pumps and other items. FDA approves Samsung Bioepis’ biosimilar; Merck to sell it in US This week, the US Food and Drug Administration (FDA) approved Samsung Bioepis' Renflexis (infliximab-abda) — a biosimilar referencing Remicade (infliximab), across all eligible indications. In the US, Renflexis is indicated for reducing signs and symptoms in patients with adult and pediatric Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, and for the treatment of adult plaque psoriasis. The FDA approval comes as a blow to Johnson & Johnson’s top earning drug Remicade, which may finally begin to experience greater competition at lower prices. Samsung Bioepis is a big player in the field of biosimilars. It has arrived in the US market close to a year after the EMA approved it for Europe. While Merck KGaA, the German Merck that specializes in chemical, pharmaceutical and life sciences sectors, sold its biosimilars business to Fresenius Kabi this week, in the US, Merck will be marketing Samsung Bioepis’ Renflexis. In Germany, Merck KGaA is selling off its entire development pipeline and an experienced team of more than 70 employees located in Aubonne and Vevey (Switzerland) to Fresenius Kabi for Euro 670 million. The product pipeline has a focus on oncology and autoimmune diseases. Confused about the two Mercks? Read: Merck vs Merck: A ‘Mercky’ Tale Doctors in India to prescribe generics; to face action if found violating norms Last week, Phispers carried news that India’s Prime Minister Narendra Modi indicated his government may bring in a legal framework under which doctors will have to prescribe generic medicines. And soon, the Medical Council of India asked all registered medical practitioners to ensure they prescribe drugs with generic names only. The MCI has asked the medical community to follow its 2016 notification in which it amended the clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 mandating the doctors to prescribe medicines by generic names in place of brand names. Therefore, if a patient is complaining of fever, the doctor must prescribe ‘paracetamol’ (the generic name drug), and not Crocin or Dolo (which are brand name drugs). This move will prevent doctors from prescribing brand-name drugs that are costlier. India’s medical regulator has also warned doctors of action against those found violating these regulations. This news comes at a time when price control on stents in India has led to companies withdrawing their innovative products from the market. A stent is a tiny expandable tube shaped mesh to open up narrowed or weakened coronary arteries. It is performed in a cath lab, using a less-invasive procedure known as angioplasty. Last week, Abbott announced it is withdrawing two of its latest coronary stents from India as they were not commercially viable. This includes a bio-absorbable stent that was introduced by the company four years back. In February this year, the National Pharmaceutical Pricing Authority had effected up to 80 percent price cuts on stents under the Drug Price Control Order (DPCO). The price of a bare metal stent was fixed at around US $113 (Rs 7,260) and drug eluting stent (DES) and biodegradable stents at around US $462 (Rs 29,600). After the controversy around DMD drug, Marathon may wind up next month After creating much hype and controversy around its effort to market a cheap overseas steroid — deflazacort — to the Duchenne muscular dystrophy (DMD) community in the US at a list price of US $ 89,000, Marathon Pharmaceuticals is now quietly planning to shut down its operations. On February 9 this year, Marathon had received FDA approval for Emflaza (deflazacort), tablets and oral suspension, to treat patients aged 5 years and older with DMD, a rare genetic disorder that causes progressive muscle deterioration and weakness. Since the drug has been approved outside the US for decades, patients in the US imported the drug from Canada and the UK, where it’s available at a price between US $1,000 or US $2,000 a year. An article published in Endpoints News cites the divestiture of deflazacort to PTC as the main reason why Marathon may not exist past May 1, 2017. When the author of the article contacted Marathon, he received the statement: “With the wind down of our Emflaza business following the close of the PTC transaction on April 20, we will continue to manage the legacy matters of Marathon Pharmaceuticals.” This news comes at a time when PTC, the company that purchased the rights for the drug from Marathon, suffered a setback as the Washington State Drug Utilization Review Board decided to recommend another medicine for the treatment of the disorder. The board endorsed a policy by the Washington State Health Care Authority, which administers the state Medicaid program, that prednisone is the “lower cost, equally effective alternative” to Emflaza, the drug that PTC bought for around US $140 million last month from Marathon. Sanofi highlights Mylan’s unfair trade practices in lawsuit Earlier this week, Sanofi SA sued Mylan NV, accusing it of engaging in illegal conduct to suppress competition to its EpiPen allergy treatment. Mylan’s EpiPen has been at the centre of a public debate on the pricing of drugs. The lawsuit was filed in Trenton, New Jersey. According to Sanofi, Mylan caused it a loss of hundreds of millions of dollars in sales by erecting barriers that denied American consumers access to and use of a rival product — Sanofi’s Auvi-Q. Auvi-Q had been introduced by the French drugmaker in 2013 to treat anaphylaxis in patients who are at risk of or have a history of the potentially fatal allergic reaction. The company ceased marketing of the product in 2015 following a recall. In a statement, Sanofi sought damages for Mylan's conduct in the market for epinephrine auto-injectors. With the lawsuit filed by Sanofi, Mylan appears to be getting a taste of its own medicine, Back in 2015, in a bold and unusual move, Mylan had sued West Virginia to keep its EpiPens on the state’s “preferred drug list”. The move failed. However, it revealed yet another way in which Mylan can use aggressive marketing and legal tactics to boost profits from EpiPens. Since Mylan acquired rights to EpiPen in 2007, the company raised its price by more than 400 percent. While Sanofi is fighting Mylan in the US, in its home country it has to address regulator’s concerns over Valproate, its treatment against epilepsy and bipolar disorders. According to the French drug regulator, up to 4,100 children in France suffered major malformations in the womb after their mothers took Valproate between 1967 and 2016. Valproate, which is manufactured in France by Sanofi under the brand Depakine for epilepsy and Depakote and Depamide for bipolar disorders, is also believed to cause slow neurological development. GSK to pay US $3m in suicide case; Teva introduces competition to Advair GlaxoSmithKline must fork out US $3 million to a woman who sued the British drug maker because her husband committed suicide after taking a generic equivalent of GSK’s antidepressant — Paxil, a federal court in the US ruled. Back in 2010, Stewart Dolin (a partner at law firm Reed Smith LLP) jumped in front of an ongoing commuter train after taking the generic version of Paxil. The verdict in favor of his wife — Wendy Dolin — was confirmed by GSK. However, the company said it should not be made liable since GSK did not manufacture or market the medicine. The lawsuit had been filed by Wendy Dolin in 2012 against GSK and Mylan — which manufactured the generic version of Paxil. However, a federal judge dismissed Mylan from the lawsuit in 2014. There was more bad news for GSK, as Israeli drugmaker Teva Pharmaceutical Industries launched the first direct competition to GSK’s best-selling Advair (an inhaler with APIs — fluticasone propionate and salmeterol). Teva had won the US regulatory nod to make an inhaler that’s similar to Advair in January this year. However, Teva also launched a generic version of its own inhaler, AirDuo RespiClick. AirDuo is not a true generic of Advair, but contains the same two APIs. However, it delivers a lower dose of salmeterol.

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27 Apr 2017

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Drug costs and prescription trends in the United States: Analyzing Medicare’s $121 billion spend

In less than three weeks, Donald Trump will assume office as the President of the United States. He has mentioned that he wants Medicare (a national social insurance program) to directly negotiate the price it pays for prescription drugs. Medicare provides health insurance to Americans aged 65 or more, who have worked and paid into the system through the payroll tax. It also provides health insurance to younger people with some disabilities or end-stage renal disease and amyotrophic lateral sclerosis. In 2015, Medicare provided health insurance to over 55 million Americans — including 46 million people aged 65 or more, and nine million younger people. As we flag off the New Year, PharmaCompass provides insights into drug prices and prescription patterns in the US in order to help professionals make informed decisions. We believe that the cost of medicines in the US, which have been a subject of much public outcry and discussions in the recent years, will continue to be scrutinized during 2017. Medicare data for 2014 Medicare Part D, also known as the Medicare prescription drug benefit — the program which subsidizes the costs of prescription drugs and prescription drug insurance premiums for Medicare beneficiaries — published a data set (for calendar year 2014) which contains information from over one million healthcare providers who collectively prescribed approximately US $121 billion worth of prescription drugs paid for under this program. For each prescriber and drug, the dataset includes the total number of prescriptions that were dispensed (including original prescriptions and any refills), and the total drug cost. The total drug cost includes the ingredient cost of the medication, dispensing fees, sales tax, and any applicable administration fees. It’s based on the amounts paid by the Part D plan, the Medicare beneficiary, other government subsidies, and any other third-party payers (such as employers and liability insurers). The total drug cost does not reflect any manufacturer rebates paid to Part D plan sponsors through direct and indirect remuneration or point-of sale rebates. In order to protect the beneficiary’s privacy, the Centers for Medicare & Medicaid Services (CMS) did not include information in cases where 10 or fewer prescriptions were dispensed. Top Ten Drugs by Cost, 2014 [Most expensive for Medicare] Drug Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Sofosbuvir 109,543 33,028 7,323 $3,106,589,192 Esomeprazole Magnesium 7,537,736 1,405,570 286,927 $2,660,052,054 Rosuvastatin Calcium 9,072,799 1,752,423 266,499 $2,543,475,142 Aripiprazole 2,963,457 405,048 130,933 $2,526,731,476 Fluticasone/Salmeterol 6,093,354 1,420,515 281,775 $2,276,060,161 Tiotropium Bromide 5,852,258 1,211,919 253,277 $2,158,219,163 Lantus Solostar (Insulin Glargine) 4,441,782 972,882 224,710 $2,016,728,436 Sitagliptin Phosphate 4,495,964 789,828 190,741 $1,775,094,282 Lantus (Insulin Glargine) 4,284,173 787,077 223,502 $1,725,391,907 Lenalidomide 178,373 27,142 9,337 $1,671,610,362 View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! Top Ten Drugs by Average Cost per Claim, 2014 [Most expensive drugs] Drug Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Average Cost Per Claim Adagen 13 $1,224,835 $94,218 Elaprase 100 $6,560,225 $65,602 Cinryze 1,820 194 196 $96,155,785 $52,833 Carbaglu 60 $2,901,115 $48,352 Naglazyme 129 $6,189,045 $47,977 Berinert 538 73 68 $25,685,311 $47,742 Firazyr 1,568 269 232 $70,948,143 $45,248 H.P. Acthar 9,611 2,932 1,621 $391,189,653 $40,702 Procysbi 314 41 47 $12,542,911 $39,946 Folotyn 15 $598,210 $39,881 Top Ten Drugs by Claims, 2014 [Most Commonly Used by Patients] Generic Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Lisinopril 38,278,860 7,454,940 464,747 $281,614,340 Levothyroxine Sodium 37,711,869 6,245,507 416,518 $631,855,415 Amlodipine Besylate 36,344,166 6,750,062 451,350 $303,779,661 Simvastatin 34,092,548 6,768,159 387,651 $346,677,118 Hydrocodone-Acetaminophen 33,446,696 8,005,790 677,865 $676,296,988 Omeprazole 33,032,770 6,707,964 475,122 $529,050,385 Atorvastatin Calcium 32,603,055 6,740,061 419,327 $747,635,818 Furosemide 27,133,430 5,176,582 456,047 $135,710,772 Metformin HCl 23,475,787 4,509,978 364,273 $203,948,989 Gabapentin 22,143,641 4,298,609 486,754 $492,557,255 View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! Top Ten Drugs by Prescribers, 2014 [Most Popular with Doctors] Generic Name Total Claim Count Beneficiary Count Prescriber Count Total Drug Cost Hydrocodone/Acetaminophen 33,446,696 8,005,790 677,865 $676,296,988 Ciprofloxacin HCl 7,253,018 4,926,835 568,201 $46,728,353 Amoxicillin 6,298,980 4,384,899 557,614 $31,193,739 Cephalexin 5,040,219 3,529,303 557,048 $36,987,401 Azithromycin 7,339,954 5,274,010 544,625 $70,699,119 Prednisone 11,032,986 4,505,821 536,108 $86,537,932 Tramadol HCl 14,250,227 4,272,724 515,816 $125,343,514 Sulfamethoxazole /Trimethoprim 4,833,758 3,090,944 500,790 $29,231,511 Gabapentin 22,143,641 4,298,609 486,754 $492,557,255 Amoxicillin/Potassium Clav 3,551,452 2,710,244 478,361 $61,713,432 The findings from CMS data The CY 2014 data represented a 17 percent increase compared to the 2013 data set and a substantial part of the total estimated prescription drug spending (as estimated by the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation, or ASPE) in the United States — at about US $ 457 billion in 2015, which was 16.7 percent of the overall personal healthcare services. Of that US $ 457 billion, US $ 328 billion (71.9 percent) was for retail drugs and US $ 128 billion (28.1 percent) was for non-retail drugs. The drug pricing process in the US is complex and reflects the influence of numerous factors, including manufacturer list prices, confidential negotiated discounts and rebates, insurance plan benefit designs, and patient choices. An IMS study found that across 12 therapy classes widely used in Medicare Part D, medicine costs to plans and patients in Medicare Part D are 35 percent below list prices. View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE! While the CMS does not currently have an established formulary, Part D drug coverage excludes drugs not approved by the US Food and Drug Administration, those prescribed for off-label use, drugs not available by prescription for purchase in the US, and drugs for which payments would be available under Parts A or B of Medicare. Part D coverage excludes drugs or classes of drugs excluded from Medicaid coverage, such as: Drugs used for anorexia, weight loss, or weight gain Drugs used to promote fertility Drugs used for erectile dysfunction Drugs used for cosmetic purposes (hair growth, etc.) Drugs used for the symptomatic relief of cough and colds Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations Drugs where the manufacturer requires (as a condition of sale) any associated tests or monitoring services to be purchased exclusively from that manufacturer or its designee Our view The Medicare program is designed such that the federal government is not permitted to negotiate prices of drugs with the drug companies, as federal agencies do under other programs. For instance, the Department of Veterans Affairs — which is allowed to negotiate drug prices and establish a formulary — has been estimated to pay (on an average) between 40 to 58 percent less for drugs, as opposed to Medicare Part D. If Trump administration kick starts direct negotiations on Medicare drug prices with drug companies, 2017 will surely turn out to be a year for the pharmaceutical industry to remember. View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!

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05 Jan 2017

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Find PharmaFlow Article for Prestwick3_000077

Prestwick3_000077

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Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

14 API Suppliers

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9 NDC API

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DEVELOPMENTS

45 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

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DOSSIERs // Finished Dosage Formulations

274 Dossiers

175 FDA Orange Book

72 Europe

5 Canada

6 Australia

8 South Africa

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DRUG PRODUCT COMPOSITION

TABLET;ORAL - 5MG

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TABLET;ORAL - 20MG

TABLET;ORAL - 1MG

TABLET;ORAL - 2.5MG

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12 Sigachi Industries

10 Gangwal Chemicals

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

9 Gangwal Healthcare

7 Seppic

7 DFE Pharma

5 Nanjing Well Pharmaceutical

5 Boai NKY Pharmaceuticals Ltd

4 Vasa Pharmachem

4 SPI Pharma

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

4 Actylis

4 Pharmatrans-Sanaq

4 Ingredion Pharma Solutions

4 Prachin Chemical

2 Ulanqab Kema New Material

2 Nanjing Bold Chemical

2 DKSH

2 Jai Radhe Sales

1 Alcedo Pharmachem

1 Rochem International Inc

1 Shijiazhuang Huaxu Pharmaceutical

1 Finar

1 Aeon Procare

1 Ideal Cures Pvt Ltd

EXCIPIENTS BY APPLICATIONS

65 Fillers, Diluents & Binders

42 Disintegrants & Superdisintegrants

38 Direct Compression

26 Granulation

21 Solubilizers

19 Thickeners and Stabilizers

18 Lubricants & Glidants

13 Parenteral

13 Co-Processed Excipients

12 Coating Systems & Additives

11 Controlled & Modified Release

10 Film Formers & Plasticizers

9 Taste Masking

9 Topical