Popular Drugs Going Off-Patent Between 2013-2016

Good for Consumers; Bad for Industry's Bottom Line

Pills on white table
Drugs Going Off Patent. Photography by ZhangXun/Getty Images

The patent expiration of blockbuster drugs not-so-fondly called the “patent cliff” by industry insiders, continued through 2016. Medicines that once generated $133 billion in U.S. sales alone will face generic competition, according to Evaluate Pharma. Some of the best-selling 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.

Drugs Going Off-Patent 2013-2016

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.
  • Opana ER (oxymorphone HCI), an opioid agonist approved for the 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 (duloxetine HCI), manufactured by Eli Lilly, is for the treatment of depression, generalized anxiety disorder, diabetic nerve pain, fibromyalgia 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 (eszopiclone), 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 (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.
  • 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. The generic drug, datomyucin, was approved July 6, 2016.
  • Zetia (ezetimibe) used to treat high cholesterol, manufactured by Merck.
  • Nuvigil (armodafinil) used to treat sleepiness related to narcolepsey and sleep apnea. Manufactured by Teva.
  • Intuniv (guanfacine hydrochloride) used to treat childhood ADHD, manufactured by Shire.
  • Seroquel XR (quetiapine fumarate) used for acute treatment of depressive episodes, manufactured by AstraZeneca.

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

EvaluatePharma Ltd. Pharmaceutical industry bracing for record patent Expiries, EvaluatePharma data reveals. February 2, 2011.

IMS Health

Company reports

Continue Reading