Popular drugs scheduled to lose U.S. market protection between 2013 and 2018:reader keep watching this post , I will keep updating with new info
Some large pharmaceutical companies like Bristol Myers, Pfizer, Eli Lilly and Merck have prepared by buying smaller biotech companies that offer interesting alternatives to their drug pipelines, suggesting a refocus on recruitment in these developing areas.
Many are looking to replace their blockbuster money-spinners with smaller, more targeted treatments. A strong skills requirement for these new inventions is a positive move for some sectors.
A swift move in to emerging markets like Brazil, India and China and alternative business models means a more dynamic global recruitment drive and a greater effort to match skills, new locations and business management as quickly as possible.
Niche products – including so-called orphan drugs – are attractive but leave these larger companies looking at a loss if they can’t convince their local regulatory body that a branded version is more commercially viable than the generic alternative.
So is it the generic drug development projects that will see the biggest impact on Life Science recruitment in the next 18 months? Or will it be established ‘big pharma’ companies moving in to emerging markets?
The global pharmaceutical market is witnessing a change as many patents of key blockbuster drugs have expired in last few years. The patent expiration of blockbuster drug fuel the growth of global generic drug pharmaceutical market. Many branded pharmaceutical companies drugs expired in last few years like Lipitor, Cozaar, Concerta,Crestor, Levaquin and Zyprexa. Market leaders such as Teva, Sandoz and Mylan are increasingly focused on generics, as this segment provides a competitive edge and presents huge profit margins. Patent expiration opens the door for generic versions which make the healthcare available to the consumers at cheaper costs as compared to the patented drugs.
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|Patent Expiring in 2011||Condition||Company||2010 U.S. Sales|
|Levaquin||antibiotics||Johnson & Johnson||$1,312,000,000|
|Concerta||ADHD/ADD||Johnson & Johnson||$929,000,000|
|Patent Expiring in 2012||Condition||Company||2010 U.S. Sales|
|Plavix||anti-platelet||Bristol-Myers Squibb /|
|Actos||type 2 diabetes||Takeda||$3,351,000,000|
Enfuvirtide (INN) is an HIV fusion inhibitor, the first of a novel class of antiretroviral drugs used in combination therapy for the treatment of HIV-1 infection. It is marketed under the trade name Fuzeon (Roche).
Enfuvirtide therapy costs an estimated US$25,000 per year in the United States. Its cost and inconvenient dosing regimen are factors behind its use as a reserve, for "salvage" therapy in patients with multi-drug resistant HIV.
USD 43 IN 2008
Another blockbuster drug Neupogen will lose its patent in 2013
Dermatoses $98.6 million December 2013
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Temodar, temozolomide, dollar 228 million in 2008
AstraZeneca's esomeprazole, indicated for acid reflux and erosive esophagitis, has held its own in sales among other branded products such as Prevacid, and remains one of the world’s largest selling drugs. This may not last. The advent of generics for the same indications, now accounting for 40% of marketed products, have cut into Nexium’s market share for the "purple pill" – which last year amounted to $5.9 billion. The proton pump inhibitor's patent history is somewhat controversial, generating some charges that this enantiomer of omeprazole provides little advantage or change but is an attempt to "evergreen" the product. In the end, though, it's an attractive market, and AstraZeneca has already brought the Indian firm Lupin to court, alleging patent infringement. Barring successful patent challenges from other firms, the first generic on the market will be Ranbaxy, licensed in 2008 by AstraZeneca to begin distribution six months before patent expiration. Finally, esomepazole carries two patents not expiring until 2018, and the trade press has wondered if these are an ace up AstraZeneca’s patent lawyers' sleeves.
Marketed by Pfizer, celecoxib, a COX II inhibitor, is indicated for arthritis pain, other acute pain, and primary dysmenorrhea. It is also marketed as Onsenal for familial adenomatous polyps. Available already as a generic in India and the Philippines, the drug was originally developed by Searle and co-promoted by Pfizer and Monsanto (whose research division was eventually acquired by Pfizer). Searle had already prevailed in a patent suit with The University of Rochester, and with Vioxx's market withdrawal in 2004, Celebrex enjoyed a large market share, even with a clinical trial underway investigating the cardiovascular risks now described in a black box warning. Pfizer expected patent exclusivity until 2015, but a Federal Circuit court, siding with Teva, invalidated the patent in question and resulted in the loss of approximately 18 months of patent protection for Pfizer. Watch for generics on May 30, 2014, when the pediatric exclusivity expires.
Maxalt, rizatriptan, USdollar 224 in 2008
Evista (raloxifene HCI), manufactured by Eli Lilly, is for treating and preventing osteoporosis. Evista earned $1.3 billion in global sales in 2010.
xCH3COOH where x = 1.4 to 2.5
Prevention of Organ Transplant Rejection
$231 million January 2014
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BARACLUDE® is the tradename for entecavir
Baraclude - After Plavix, Baraclude is the next significant challenge that BMS will have to face immediately. It is used in the treatment of chronic hepatitis B infection and fetched almost $1.4 billion in revenues for the firm in 2012. In February 2013, the composition of matter patent covering this drug was invalidated by the U.S. district court for the district of Delaware. Originally, the patent was scheduled to expire in 2015, but now the drug may face generic competition in the U.S. as early as in 2013. The firm will continue to sell in other parts of the world without competition from generic drugs until 2016.
Included here because of its original patent expiration in 2014, Bristol-Myers has won a pediatric exclusivity extension for aripiprazole until April, 2015...unless Teva prevails in its patent challenge initiated in 2007. Judging by the product's growth rate, watch for more patent challenges – in 2009, the product yielded $606 million – a 31% jump over the previous year. Indicated for bipolar disorders, schizophrenia, autism and as an add-on to an antidepressant, aripiprazole was recently approved for treatment of children over 10 for bipolar disorder, and the product carries the expected atypical antipsychotic black box warnings for suicidal thoughts in children and young adults.
The antipsychotic and anti-depressant drug is the next bestselling drug after Plavix. The drug was developed by Otsuka in Japan, and it markets the drug in partnership with BMS in the U.S and Europe. The drug brought in $2.8 billion in revenues for BMS in 2012. However, BMS’s rights to commercialize the drug in EU and U.S. will end in 2014 and 2015 respectively. Simultaneously, Otsuka’s U.S. patent for the drug expires in 2014, and the drug will face competition from generic products soon.
Teva Pharmaceuticals claims two companies are violating patents on Copaxone, glatiramer acetate for Multiple Sclerosis (MS). The original suit against Momenta Pharmaceuticals and Sandoz now has expanded to include ten patents, three of which run past the expected generic drug entry of 2014…so when generics will appear is now an open question. Copaxone, approved as an orphan drug, is Teva's flagship product, with sales of over $680 million a year. In addition to being in clinical trials for various combinations, dosage rates, and administration strategies in the mitigation of MS, the drug is now also being studied for macular degeneration and Crohn's Disease.
Gleevec (imatinib mesylate) is a treatment for chronic myeloid leukemia (CML)and gastrointestinal stromal tumor (GIST). Global sales were $4.26 billion in 2010. Gleevec is manufactured by Novartis.
|Gleevec®||imatinib||2015-01||exp---------Chronic myeloid leukemia, gastrointestinal stromal tumors||NOVARTIS|
Namenda (memantine HCI) is a treatment for moderate to severe Alzheimer's disease manufactured by Forest Laboratories, Inc.
Provigil (modafinil), a treatment for excessive sleepiness and shift work sleep disorder, is manufactured by Teva Pharmaceuticals. The product generated $350 million in sales in 2011.
C20H30BrNO3•H2O ipratropium bromide Mol. Wt. 430.4
Zyvox (linezolid) is an antiviral manufactured by Pfizer. The company reported global sales of $325 million in 2011.
Prezista (darunavir) is a protease inhibitor for human immunodeficiency virus (HIV) infection. Distributed by Janssen Therapeutics, Prezista sales were $888 million globally in 2010.
Renagal sevelamer, us dollar 400 in 2008
Sustiva is a drug from BMS for the treatment of HIV. When sold along with another drug called Truvada* (which is developed by Gilead, an American biotechnology company) in a fixed-dose combination, the package is called Sustiva franchise. Such fixed dose combinations help simplify HIV therapy for patients and providers. BMS made over $1.5 billion in revenues from this franchise in 2012. The patent for Sustiva ends in 2013 and 2015 for E.U and U.S respectively. However, this is not likely to end the exclusivity for the combination therapy as described above. We expect a gradual decline in the sales of Sustiva as more companies develop generic variants and know how about the variants increases in the market.
Type II Diabetes Mellitus
$385 million March 2015
& Vomiting; Prevention of
Post-Op Nausea & Vomiting
$114 million April 2015
LOVAZA (omega 3 fatty acids)
Hypertriglyceridemia $998 million Q1 2015
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Adalimumab (HUMIRA, AbbVie) is the third TNF inhibitor, after infliximab and etanercept, to be approved in the United States. Like infliximab and etanercept, adalimumab binds to Tumor necrosis factor-alpha (TNFα), preventing it from activating TNF receptors. Adalimumab was constructed from a fully human monoclonal antibody, while infliximab is a mouse-human chimericantibody and etanercept is a TNF receptor-IgG fusion protein. TNFα inactivation has proven to be important in downregulating theinflammatory reactions associated with autoimmune diseases. As of 2008 adalimumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis. Although only approved for ulcerative colitis from late 2012 by the FDA in the disease's management, it has been used for several years in cases that have not responded to conventional treatment at standard dosing for Crohn's Disease.
cinacalcet, sensipar amgen
Cinacalcet (INN) is a drug that acts as a calcimimetic (i.e. it mimics the action of calcium on tissues) by allosteric activation of thecalcium-sensing receptor that is expressed in various human organ tissues. It is sold by Amgen under the trade name Sensiparin North America and Australia and as Mimpara in Europe. Cinacalcet is used to treat secondary hyperparathyroidism (elevatedparathyroid hormone levels), a consequence of end-stage renal disease. Cinacalcet is also indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma
Benicar (olmesartan medoxomil) for high blood pressure is manufactured by Daiichi Sankyo, Inc. In 2010, sales were $2.5 billion.
ADVAIR, fluticasone propionate, Salmeterol xinafoate
Reyataz - Reyataz is another drug for the treatment of HIV. BMS develops it under a worldwide license from Novartis and markets it as a combination with Norvir, a drug from Abbott Laboratories. The market exclusivity for the drug ends in U.S., Canada and China in 2017 and in major EU countries and Japan in 2019. The drug accounted for $1.5 billion of BMS’s 2012 revenues.
byetta,exenatide. usd 627 in 2008
Orlistat (also known as tetrahydrolipstatin) is a drug designed to treat obesity. It is marketed as a prescription under the trade name Xenical by Roche in most countries, and is sold over-the-counter as Alli by GlaxoSmithKline in the United Kingdom and the United States. Its primary function is preventing the absorption of fats from the human diet by acting as alipase inhibitor, thereby reducing caloric intake. It is intended for use in conjunction with a healthcare provider-supervisedreduced-calorie diet
NIZORAL® is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, corn starch, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxyl]phenyl] piperazine
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|Protection Expiry Year||US||Japan||UK||France||Germany|
Risperdal® Consta® LP
Off Going Patents 2013-2016