In a blow to consumers and several manufactures of generic drugs, the U.S. Patent Office has extended Pfizer’s patent on Celebrex, the multi-billion dollar pain drug for treating rheumatoid arthritis and osteoarthritis.
The extension gives Pfizer (NYSE:PFE) another year and a half of selling a drug that has annual sales of more than $1.7 billion in the U.S. and nearly $3 billion worldwide. It also means cheaper generic versions of celecoxib, which is sold under the Celebrex brand name, may not be available to consumers until the end of 2015.
Currently, a bottle of 60 capsules of 200 mg Celebrex sell for about $340. Generic versions would sell for a fraction of that.
“Continued development of new medicines that enhance patient lives is supported by protecting intellectual property and innovation,” said Amy Schulman, executive vice president and general counsel for Pfizer. “We are pleased with the reissuance of this patent protecting the invention of using celecoxib to treat osteoarthritis and other approved conditions, and have initiated legal proceedings to enforce our intellectual property rights.”
Pfizer filed suit against Teva Pharmaceuticals (NYSE:TEVA), Mylan Pharmaceuticals Inc.(NASDAQ: MYL) , Watson Laboratories, Lupin Pharmaceuticals and Apotex to prevent them from selling generic versions of Celebrex until late 2015.
The companies had filed a new drug application with the Food and Drug Administration seeking approval to market a generic form of celecoxib beginning in May 2014, prior to the December 2, 2015 expiration of Pfizer’s patent, which includes six months of pediatric exclusivity.
The original patent for Celebrex expires on May 30, 2014. But the U.S. Patent & Trademark Office agreed to a reissued patent covering methods of treating arthritis and other medical conditions.
The longer a company can hold a patent, the more profitable the drug can be for its bottom line. That’s because branded drugs can quickly lose upwards of 80 percent of sales once multiple generic versions become widely available.
Celebrex, which first went on sale in the late 1990s, is in the same class of drugs as Vioxx, a nonsteroidal anti-inflammatory drug (NSAIDs) that was withdrawn from the market in 2004 after a study showed it increased the risk of heart attacks and strokes.
Concern that it might carry the same risks as Vioxx caused sales of Celebrex to drop, but an aggressive marketing campaign pushed sales back up to $2 billion by 2006.
Like all prescription NSAIDs, Celebrex may increase the chance of heart attack or stroke that can lead to death. This chance increases if you have heart disease or risk factors such as high blood pressure or when NSAIDs are taken for long periods.
Osteoarthritis is the most common type of arthritis, affecting approximately 27 million adults in the United States, causing pain and stiffness in the joints. Before age 55, osteoarthritis occurs equally in men and women. After age 55, it is more common in women.