Lisinopril Dihydrate

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TABLET;ORAL - 10MG
TABLET;ORAL - 2.5MG
TABLET;ORAL - 20MG
TABLET;ORAL - 30MG
TABLET;ORAL - 40MG
TABLET;ORAL - 5MG
TABLET;ORAL - 12.5MG;10MG
TABLET;ORAL - 12.5MG;20MG
TABLET;ORAL - 25MG;20MG

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Analyzing over US$ 90 billion of Medicare Prescription Drug (Part D) Spending in 2016

This week, PharmaCompass reviews the recently released data on prescription drugs paid for under the Medicare Part D Prescription Drug Program in the United States in calendar year 2016. But first, let’s understand what is Medicare. Medicare is the federal health insurance program in the US. In 2017, it covered 58.4 million people — 49.5 million aged 65 and older, and 8.9 million disabled. Prescription drug coverage under this program was started in 2006, and is known as Medicare Part D. As part of this coverage, the Centers for Medicare & Medicaid Services (CMS) contracts insurance companies and other private companies, known as plan sponsors, that offer prescription drug plans to their beneficiaries with varying drug coverage and cost-sharing requirements. In 2017, the Congressional Budget Office (CBO) had estimated that spending on Medicare Part D would reach US$ 94 billion, or about 16 percent of all Medicare expenditures for the year. Click here to access the compilation of Medicare Part D Prescriber Summary Report According to the CBO, Medicare Part D is the most significant expansion of the Medicare program since it was created by Congress in 1965. With more than 1.48 billion claims from beneficiaries enrolled under the Part D prescription drug benefit program under its umbrella, our analysis of Medicare Part D provides valuable insights into how elderly Americans use prescription drugs. Top 10 drugs by cost: The ones that bore the highest cost burden for Medicare As in 2015, in 2016 too Gilead’s Hepatitis C treatment — Ledipasvir/Sofosbuvir (Harvoni) — remained the single drug highest payout under the Medicare Part D Prescription Drug Program with a total cost of US$ 4.4 billion. As Gilead continued to face competition from AbbVie and Merck in the Hepatitis C space, the spending on Harvoni was down 37 percent from US$ 7.03 billion in 2015. Click here to access the compilation of Medicare Part D Prescriber Summary Report Celgene’s cancer treatment, Lenalidomide (Revlimid), Sanofi and Merck’s diabetes treatments and AstraZeneca’s Crestor (Rosuvastatin Calcium) for cholesterol followed Harvoni. All together, they cost the Medicare program over US$ 10 billion. Generic Name Number of Medicare Part D Claims Number of Medicare Beneficiaries Number of Prescribers Aggregate Cost Paid for Part D Claims (In USD) LEDIPASVIR/ SOFOSBUVIR (HARVONI) 141,665 52,782 12,097 4,398,534,465 LENALIDOMIDE 239,049 35,368 10,382 2,661,106,127 LANTUS SOLOSTAR (INSULIN GLARGINE, HUM.REC.ANLOG ) 5,028,485 1,075,248 245,447 2,526,048,766 SITAGLIPTIN PHOSPHATE 4,742,505 864,442 206,223 2,440,013,513 ROSUVASTATIN CALCIUM 6,012,444 1,560,050 249,981 2,322,724,007 FLUTICASONE/SALMETEROL 5,194,391 1,196,007 275,442 2,319,808,482 PREGABALIN 4,940,115 852,497 267,532 2,098,953,250 RIVAROXABAN 4,403,332 807,820 252,141 1,954,748,890 APIXABAN 4,455,782 826,969 231,631 1,926,107,484 TIOTROPIUM BROMIDE 4,153,162 903,494 235,564 1,818,857,361 Click here to access the compilation of Medicare Part D Prescriber Summary Report Top 10 drugs by claims: The most commonly used drugs of 2016 With 46.6 million claims, the thyroid hormone deficiency treatment — Levothyroxine Sodium — retained its position of being the most claimed product under Medicare’s Part D Prescription Drug Program in 2016. The number of Medicare Part D claims includes original prescriptions and refills. Following Levothyroxine Sodium was the lipid-lowering agent — Atorvastatin Calcium — which had 44.5 million Medicare Part D claims that were filed by almost 9.4 million beneficiaries. Generic Name Number of Prescribers Number of Medicare Part D Claims Number of Medicare Beneficiaries LEVOTHYROXINE SODIUM 669,999 46,617,109 8,091,785 ATORVASTATIN CALCIUM 494,973 44,595,686 9,435,633 AMLODIPINE BESYLATE 497,017 39,913,468 7,802,905 LISINOPRIL 490,452 39,469,840 8,009,954 OMEPRAZOLE 492,951 32,909,236 7,001,160 METFORMIN HCL 611,700 31,007,932 6,394,014 SIMVASTATIN 380,560 29,687,947 6,201,911 HYDROCODONE/ACETAMINOPHEN 660,617 28,595,150 7,265,882 FUROSEMIDE 488,352 27,878,243 5,421,598 GABAPENTIN 555,997 27,627,466 5,363,382 Click here to access the compilation of Medicare Part D Prescriber Summary Report Top 10 drugs by prescribers: Medicines that were most popular with doctors Among the prescribers, albuterol sulfate (salbutamol) and Diltiazem had over 900,000 unique providers (or doctors) prescribing the drug. Albuterol (salbutamol) is used to provide quick relief from wheezing and shortness of breath while Diltiazem is used to prevent chest pain (angina). Also on the list of popular drugs with prescribers is Hydrocodone-Acetaminophen. With more doctors prescribing Hydrocodone-Acetaminophen (an opioid) than commonly used antibiotics, such as Cephalexin, Ciprofloxacin and Amoxicillin, the series of new FDA initiatives to combat the epidemic of opioid misuse and abuse should change the position of opioids in the top 10 drugs by prescribers in the coming years. Click here to access the compilation of Medicare Part D Prescriber Summary Report Generic Name Number of Prescribers Number of Medicare Part D Claims Number of Medicare Beneficiaries ALBUTEROL SULFATE 985,427 13,100,354 5,417,718 DILTIAZEM HCL 931,159 8,142,004 1,982,550 POTASSIUM CHLORIDE 879,491 18,945,969 4,278,000 PEN NEEDLE, DIABETIC 677,210 5,281,778 1,795,046 LEVOTHYROXINE SODIUM 669,999 46,617,109 8,091,785 HYDROCODONE/ACETAMINOPHEN 660,617 28,595,150 7,265,882 METFORMIN HCL 611,700 31,007,932 6,394,014 CEPHALEXIN 597,647 5,603,879 3,933,373 CIPROFLOXACIN HCL 594,129 7,000,081 4,851,657 AZITHROMYCIN 591,028 7,958,625 5,734,122 What does the future hold? Although the Part D Prescriber PUF (public use file) has a wealth of information on payment and utilization for Medicare Part D prescriptions, the dataset has a number of limitations. Of particular importance is the fact that the data may not be representative of a physician’s entire practice or all of Medicare as it only includes information on beneficiaries enrolled in the Medicare Part D prescription drug program (i.e., approximately two-thirds of all Medicare beneficiaries). Click here to access the compilation of Medicare Part D Prescriber Summary Report Last month, the Office of the Inspector General (OIG) reviewed the Part D claims data for the years 2011 to 2015 for brand-name drugs. The OIG’s report found that the total reimbursement for all brand-name drugs in Part D increased 77 percent from 2011 to 2015, despite a 17-percent decrease in the number of prescriptions for these drugs. With soaring drug prices being an issue for regular debate in the Unites States and President Trump announcing that his team will use strategies to strengthen the negotiating powers under Medicare Part D and Part B, it remains to be seen how the data on prescription drugs paid for under the Medicare Part D Prescription Drug Program will change in the coming years. Click here to access the compilation of Medicare Part D Prescriber Summary Report

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05 Jul 2018

Dead fish in Hyderabad puts pharma majors under scrutiny; False data uncovered in AstraZeneca’s US$ 4 billion buy

This week, Phispers has news from across the world. While China is trying to speed up approval of drugs by accepting data from overseas trials, the US achieved record approval of generic drugs last fiscal. In India, pharma companies may face legal action for releasing effluents into a lake in Hyderabad that killed thousands of fish last week. In France, a reformulated thyroid pill from Merck led to severe side effects in patients. And, there was more bad news for Israel’s Teva as its competitors won approvals from regulators in the US and Europe to market cheaper versions of its blockbuster multiple sclerosis drug — Copaxone. Data-integrity uncovered in AstraZeneca’s US$ 4 billion Acerta buy In February 2016, pharma giant AstraZeneca had invested US$ 4 billion in acquiring 55 percent stake in Acerta Pharma — a biopharmaceutical company based in the Netherlands and the US. The acquisition provided AstraZeneca with a cancer drug under clinical trials — acalabrutinib. An AstraZeneca press release issued at the time of acquisition had said: “Acalabrutinib is a highly selective, irreversible, second generation BTK inhibitor, with approximately 1,000 patients treated to date in clinical studies across the entire development programme.” But the acquisition brought some bad news for AstraZeneca last week, as a story published in Retraction Watch said one of Acerta’s former researchers had falsified early data on acalabrutinib. “The data, published as an abstract in August 2015 in the journal Cancer Research, reported a therapeutic benefit of acalabrutinib in a mouse model of pancreatic cancer,” the report said. The drug is now in human trials. Additional trials published in the New England Journal of Medicine and Blood in 2015 showed acalabrutinib had “promising safety and efficacy profiles in patients” with relapsed chronic lymphocytic leukemia. However, investigation into the data underlying the 2015 abstract revealed some of it was falsified. As a result, the journal retracted on the abstract. Interestingly a few weeks ago, acalabrutinib had won breakthrough therapy status at the US Food and Drug Administration (US FDA) along with an accelerated review plan for its first approval. However, all news was not bad news for AstraZeneca. Its innovative treatment for a type of lung cancer won “breakthrough” designation by the US FDA. The endorsement is for therapy Tagrisso for use in the US by patients with previously-untreated non-small cell lung cancer and a genetic mutation known as EFGR. This paves the way for fast-track approval of the drug. Dead fish in Hyderabad leads to pharma majors being booked for fouling lake water Pharmaceutical companies in India — such as Hetero Pharma, Aurobindo Pharm, Mylan, SMS Pharma, Vantec and Sriram — that have their manufacturing facilities in Kazipally industrial area and Industrial Development Area (IDA) have been booked under a case for “fouling water of public spring or reservoir”. This happened last week after the Gandigudem lake, which is barely a few meters away from Hyderabad's Outer Ring Road (ORR), reported hundreds of bloated, dead fish washed ashore after it rained heavily. The 266-acre lake is situated near the IDA. The lake has been plagued with pollution for a while now. According to news reports, the Pollution Control Board (PCB) had found traces of chloromethane, a solvent used in the pharma industry, in the samples of the water and dead fish collected from the lake. The diluted traces of the chemical in the lake confirm contamination. Officials said that 230,000 fish had been washed ashore within a span of two days, causing heavy loss to the fishermen dependent on the lake. According to an official, the fish lost was worth US$ 230,038 (Rs 15 million) These companies have been booking under Section 277 (fouling water of public spring or reservoir) and Section 278 (making atmosphere noxious to health) of the Indian Penal Code. A video of a news report on the story can be viewed here. China to accept data from overseas trials in order to speed up drug approvals China plans to speed up approval of drugs, and will accept data from overseas clinical trials in order to facilitate that. The move could be a boon for international drugmakers as well as for patients who often face lengthy delays for new medicines to reach the market. China has approved just over 100 innovative new drugs in the last 15 years — about a third of the drugs approved in the developed markets. This is the key reason behind the country taking this step to speed up drug approvals. The move also seeks to address high medicine costs, and improve access to healthcare for China’s 1.4 billion population. The Chinese Cabinet will also look into improving the protection of medical intellectual property and boost the number and quality of clinical trial testing centers in China. However, the proposals contained no timeline for implementation. In March this year, China had proposed ways to speed up approvals for imported drugs, including reforming clinical trial requirements. Merck’s French reformulation of most prescribed US drug leads to severe side effects Popular thyroid drug Levothyroxine reportedly received many complaints of severe side effects from patients in France. The drug works as a stand-in for the hormone thyroxine in patients suffering from hypothyroidism, a condition that affects the body’s metabolism. According to a Reuters report, French police searched German drugmaker Merck KGaA’s plant in Lyon last week as part of a probe into complaints by patients about changes to its thyroid drug Levothyrox. In March this year, Merck had removed lactose from Levothyrox to make it easier to tolerate and replaced it with citric acid and mannitol, a type of sugar alcohol. The new formulation had been requested by the French medicines regulator ANSM in 2012. According to patients, this resulted in severe side effects such as memory loss, hair loss, weight gain and palpitations. Around 3 million people in France, 80 percent of them women, use Levothyrox. According to a Medscape article, levothyroxin is also the most prescribed drug in the US. The prescriptions for Levothyroxine (in the US) stood at 112 million in 2012 and 123 million in 2016. The drug was far ahead of the number two drug on the list (Lisinopril — with 99 million prescriptions in 2012 and 110 million in 2016). Last month, a prosecutor in Marseille had launched a probe into whether Merck had deceived patients with the change in the drug’s formula. Since then, Merck has restored the original drug to the market. Teva fights to hold market share as competitors receive nod for its blockbuster drug Bad news from Israeli generic drug giant Teva Pharmaceutical Industries doesn’t seem to relent. Last week, Teva was taken unawares when its competitors won approvals from regulators in the US and Europe to market cheaper versions of its flagship Copaxone drug for multiple sclerosis. The launch of the competing products will result in “significant declines” in Teva’s largest product effective this year, Moody’s Investors service said in a note. On October 3, Mylan said it received approval from the US FDA for the marketing of generic versions of Teva’s Copaxone (glatiramer acetate) in 40 mg and 20 mg dosages. Mylan said it would start shipping the generic version immediately. According to Bernstein analyst Ronny Gal, Mylan is serving up 25 to 30 percent discounts versus the “prevailing price” on Teva’s Copaxone and Teva is countering it, he added. Analysts had written off Mylan’s long-delayed generic Copaxone until next year. The approval last week surprised analysts and investors. Two days later, Alvogen said it had received an approval from European regulators to market the 40 mg dose of generic Copaxone in Europe. Alvogen has been selling the 20 mg dose of the drug in Europe. These approvals could mean a “downside” to both revenue and profit estimates for 2018, Citi’s Liav Abraham said. Generic drug approvals in US hit all time high; Indian firms corner large chunk The US FDA approved a record 763 generic drugs in the US fiscal year that ended on September 30, 2017. Amongst these, Indian companies accounted for nearly 40 percent of the approvals, a news report published in the Mint said. The regulator also gave 174 tentative approvals during 2016-17. In comparison, the US FDA had approved 651 generic drugs last year, the latest Activities Report of the Generic Drug Program of the FDA said. Indian companies received a total of 295 product approvals in 2016-17. Amongst them, “the pace of drug approvals was strong for Aurobindo Pharma, Cadila Healthcare and Lupin,” the Mint report added. As per the FDA report, total filings of abbreviated new drug applications (ANDAs) for generic drugs with the US FDA rose to 1,292 in 2016-17 from 852 a year ago. According to analysts, the increasing number of product approvals and filings indicate an increase in competitive intensity in the US, which is a major market for many Indian drug companies. This would also result in more pressure on drug pricing.

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12 Oct 2017

FDA’s 2016 Approvals of New Drugs, Formulations, Strengths & More

After 2 years of sky-high approval numbers, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research approved 22 novel drugs in 2016, down from the 19-year high of 45 in 2015. The FDA also approved many new dose forms, formulations, combination products and vaccines. This week, PharmaCompass, shares its analysis of the new drug approvals by the FDA in 2016. Reasons behind the low approvals in 2016 Of the 22 novel drugs approved by the FDA, the FDA approved 9 products with orphan designation, in line with the industry’s recent focus on rare diseases. However, as the industry shifts its focus towards biotechnology, only 7 of the novel products approved were biologic applications. The 9 orphan designees approved (41% of all new drug approvals) were significantly lower than the 21 (47%) orphan designees approved in 2015 and 17 (41%) in 2014. FDA’s approval of 4 (18%) oncology drugs in 2016, was also down from the 14 (31%) approvals in 2015, 9 (22%) in 2014 and 9 (33%) in 2013. The reasons for the low 2016 approval count, have been attributed to the agency approving five drugs in 2015 that actually had approval action dates in 2016 and an increase in the number of drugs that the agency rejected. A key reason for the rejections was the sponsors’ failure to comply with good manufacturing practice regulations. Click here to access our list of all New Drug Approvals (Excel version available) for FREE! Gilead’s Epclusa, the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with chronic hepatitis C virus (HCV) infection, is expected to become the most profitable approval of 2016 with expected sales of $ 8.4 billion by 2022. 2016 also saw the FDA’s contentious approval of Exondys 51™ (eteplirsen) under its accelerated approval process. Exondys 51™ treats Duchenne muscular dystrophy (DMD), a rare genetic disease which causes progressive muscle wasting that affects around 20,000 boys and young men in the United States. Approvals of three biosimilars which target $ 33 billion in brand drug sales In a giant leap for the generic pharmaceutical industry, three biosimilar applications were approved in 2016 that target brand drugs which generated more than $ 33 billion in sales last year. All the three biosimilars approved were tumor-necrosis factor alpha (TNF α) inhibitors used to manage inflammatory conditions. Pfizer and Celltrion’s Inflectra, a biosimilar to Janssen’s Remicade® (2016 sales - $ 8.8 billion), was the first to get approval for all Remicade-approved indications, except pediatric ulcerative colitis. Inflectra was launched at risk in November 2016. After Inflectra’s approval, the FDA approved Sandoz’s Erelzi, a biosimilar to Enbrel® (etanercept – Amgen, 2016 sales - $ 9.1 billion). On Sept. 23, 2016, Amgen’s Amjevita™ (adalimumab – atto), a biosimilar of the world’s best-selling drug by revenue, AbbVie’s Humira®(2016 sales - $ 16.4 billion), was also approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis. Click here to access our list of all New Drug Approvals (Excel version available) for FREE! Kim Kardashian’s pregnancy drug is now available in a new strength Diclegis, a combination of an antihistamine (doxylamine succinate) and a form of vitamin B6 (pyridoxine HCl), made headlines when the FDA issued a warning letter for the social media promotion of the drug by Kim Kardashain, star of the reality show ‘Keeping Up With The Kardashians’ Duchesnay, the company which produces Diclegis, got approval for Bonjesta which combines twice the amount of doxylamine and pyridoxine when compared with Diclegis which contains 10mg of each ingredient. Indian generic companies get approvals for differentiated products As the generic industry in the U.S. continues to face severe pricing pressure, Indian generic companies are attempting to overcome these challenges by trying to move up the value chain by supplying differentiated generic products. Consistent with this strategy, the applications of Sun Pharmaceuticals for a new ophthalmic version of Bromfenac (Bromsite) and Dr. Reddy’s Laboratory for an injectable version of Sumatriptan (Zembrace™ SymTouch) to treat migraines were also approved. Click here to access our list of all New Drug Approvals (Excel version available) for FREE! Pfizer launches an opioid treatment with abuse-deterrent properties The abuse of opioids, including prescription painkillers and drugs like heroin, is something the United States has struggled with since before the 1900s. Last year, the FDA announced that immediate-release opioid painkillers such as oxycodone and fentanyl will have to carry a "black box" warning about the risk of abuse, addiction, overdose and death. Pfizer got approval last year for Troxyca ER a combination containing oxycodone and naltrexone. Troxyca ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. In it, the oxycodone releases slowly over several hours. If the capsules are crushed, the encased naltrexone mixes with oxycodone, essentially cancelling any euphoric effects. Pfizer also received approval for an extended release form of Tofacitinib (Xeljanz® XR) to treat adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Click here to access our list of all New Drug Approvals (Excel version available) for FREE! A dietary supplement gets approved along with new forms of commonly used drugs In 2016, Endoceutics got Intarosa, a once-daily vaginal insert, approved which is the first FDA approved product to contain prasterone, also known as dehydroepiandrosterone (DHEA). Although DHEA is included in some dietary supplements, the efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating or preventing any disease. Lisinopril, the most commonly used drug by U.S. Medicare patients, was approved as an Oral Solution for the first time. Diabetes treatments, one of the most commonly prescribed drug categories in the U.S., saw the addition of Sanofi and Novo Nordisk’s fixed-dose, long-acting insulin and glucagon-like peptide 1 (GLP-1) agonist combinations to the list of options available to treat adult type-2 diabetes. Our View The approval of new drugs ensures that the world has access to improved healthcare solutions and breakthrough medical therapies. With Donald Trump “focused on accelerating the FDA” and an on-going argument that drugs should not have to be proven effective before getting approved, this year looks like the one where the new drug approval scenario will be shaken up for time to come. Click here to access our list of all New Drug Approvals (Excel version available) for FREE!

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09 Feb 2017

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

Find PharmaFlow Article for Lisinopril Dihydrate

Lisinopril Dihydrate

Lisinopril Dihydrate

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

34 API Suppliers

20 USDMF

17 CEP/COS

7 JDMF

6 EU WC

1 KDMF

9 NDC API

12 Listed Suppliers

DEVELOPMENTS

3 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

4 Suppliers

DOSSIERs // Finished Dosage Formulations

658 Dossiers

165 FDA Orange Book

288 Europe

39 Canada

32 Australia

48 South Africa

86 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - 10MG

TABLET;ORAL - 2.5MG

TABLET;ORAL - 20MG

TABLET;ORAL - 30MG

TABLET;ORAL - 40MG

TABLET;ORAL - 5MG

TABLET;ORAL - 12.5MG;10MG

TABLET;ORAL - 12.5MG;20MG

TABLET;ORAL - 25MG;20MG

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77 Fillers, Diluents & Binders

39 Direct Compression

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