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Which Popular Drugs Are Going Off-Patent in 2013-2016?

Good for consumers; bad for industry's bottom line.

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Which Popular Drugs Are Going Off-Patent in 2013-2016?

AstraZeneca's popular anti-cholesterol drug Crestor will lose market exclusivity in 2016.

Some of the biggest blockbuster drugs in history lost patent protection in 2011 and 2012. Drugs like Lipitor, Plavix and Viagra earned billions for their sponsors while setting global sales records.

The patent expiration of big-sellers, not-so-fondly called the “patent cliff” by industry insiders, continues through 2016. It also means that medicines that currently generate $133 billion in U.S. sales alone will face generic competition, according to Evaluate Pharma.

Popular drugs scheduled to lose U.S. market protection between 2013 and 2016:

2013

Oxycontin (oxycodone HCI), an opioid for pain management, earned $2.8 billion in sales in 2011 for its U.S. manufacturer, Purdue Pharma LP.

AcipHex (rabeprazole sodium), for heartburn associated with acid reflux disease, manufacturer: Eisai Inc. and Janssen Pharmaceuticals, Inc.

Zometa (zoledronic acid) injection is a treatment for hypercalcemia of malignancy caused by high calcium blood levels due to cancer; $1.5 billion in global sales in 2010. Manufactured by Novartis.

Xeloda (capecitabine) is an oral chemotherapy treatment for metastatic colorectal and breast cancer manufactured by Genentech/Roche. U.S. sales were growing by double digits annually to reach $647.6 million in 2011.

Oplana ER (oxymorphone HCI), an opioid agonist approved for management of moderate to severe pain, manufactured by Endo Pharmaceuticals Inc. Sales in 2011 were $384.7 million.

Asacol (mesalamine), for the treatment of ulcerative colitis symptoms, earned $800 million in worldwide sales in 2010. Manufacturer: Warner Chilcott

2014

Nexium (esomeprazole) for the treatment of gastroesophageal reflux disease (GERD) is manufactured by AstraZeneca. Global sales in 2010 were $4.9 billion.

Cymbalta (duloxitine HCI), manufactured by Eli Lilly, is for the treatment of depression, generalized anxiety disorder, diabetic nerve pain, fibromylagia and chronic musculoskeletal pain. Global sales exceeded $4 billion in 2011.

Celebrex (celecoxib) is for the treatment of osteoarthritis and rheumatoid arthritis symptoms and management of acute pain in adults. Pfizer, its manufacturer, reported sales of $2.5 billion in 2011.

Symbicort (budesonide/formoterol fumarate dihydrate) for asthma and COPD is manufactured by AstraZeneca. Sales of Symbicort were $3.1 billion in 2011.

Lunesta (szopiclone), a treatment for insomnia, is manufactured by Sunovion Pharmaceuticals Inc., a subsidiary of Dainippon Sumitomo Pharma Co. Ltd. Global sales in 2010 were $631 million.

Restasis (cyclosporine ophthalmic emulsion) for increasing tear production in patients with chronic dry eyes, is manufactured by Allergan. In 2010, worldwide sales reached $621 million.

Evista (raloxifene HCI), manufactured by Eli Lilly, is for treating and preventing osteoporosis. Evista earned $1.3 billion in global sales in 2010.

Sandostatin LAR (octreotide acetate for injectable suspension) by Novartis, is for the treatment of acromegaly syndrome, a hormonal disorder, and severe diarrhea and flushing associated with metastatic cancers. Global sales were $1.3 billion in 2010.

Actonel (risedronate) is for the prevention and treatment of osteoporosis. In 2010, worldwide sales were $1.6 billion. Actonel is manufactured by Warner Chilcott.

2015

Abilify (aripiprazole) by Otsuka Pharmaceutical is an anti-psychotic used to treat the symptoms of schizophrenia and bipolar disorder. In 2010, global sales reached $4.6 billion.

Copaxone (glatiramer acetate injection) is a treatment for relapsing-remitting multiple sclerosis (RRMS) manufactured by Teva Pharmaceuticals. Sales reached $3.57 billion in 2011.

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.

Namenda (memantine HCI) is a treatment for moderate to severe Alzheimer's disease manufactured by Forest Laboratories, Inc.

Provigil (modofinil), a treatment for excessive sleepiness and shift work sleep disorder, is manufactured by Teva Pharmaceuticals. The product generated $350 million in sales in 2011.

Combivent (albuterol and ipratropium inhalation) is management of for chronic obstructive pulmonary disease (COPD) symptoms. Boehringer Ingelheim reported sales of $965 million in 2010.

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.

Avodart (dutasteride) is a treatment for benign prostatic hyperplasia (enlarged prostate gland). GlaxoSmithKline reported sales of $973 million worldwide 2010.

2016

Crestor (rosuvastatin calcium) by Astra Zeneca, is a treatment for lowering LDL cholesterol I the bloodstream. Crestor sales were $6 billion in 2010.

Benicar (olmesartan medoxomil) for high blood pressure is manufactured by Daiichi Sankyo, Inc. In 2010, sales were $2.5 billion.

Cubicin (daptomycin) is an anti-viral manufactured by Cubist Pharmaceuticals. The drug generated $644 million in global sales in 2010.

For a list of products that went off patent in 2011 and 2012 see Evaluate Pharma's analysis on the patent storm. Of course, there are many things that can go wrong when a generic company tries to launch a new product into a competitive marketplace.

Sources: Evaluate Pharma, IMS Health, Company reports
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