FDA extends Plavix patent by 6 months to May 2012

Jan 25, 2011 By MATTHEW PERRONE , AP Health Writer

(AP) -- The makers of Plavix, the world's second best-selling medication, said Tuesday they will retain exclusive U.S. marketing rights to the blood thinner for an additional six months, under a decision by U.S. health regulators.

The marketing extension will help Bristol-Myers Squibb Co. and partner Sanofi-Aventis delay the financial crunch hitting nearly all drugmakers, as patents on a wave of blockbuster drugs from the 1990s begin to expire.

The companies announced that the granted a six-month extension for Plavix after the companies conducted extra studies of the drug in infants. The FDA program is designed to reward companies for testing drugs in children, who are typically excluded from medical studies.

With the extension, the companies will be able to market the drug exclusively until May 17, 2012.

Plavix posted $9.1 billion in sales globally in 2009, according to health care data firm IMS Health. Only Pfizer's Lipitor had higher sales, at 13.3 billion. In the U.S., Plavix generated $5.6 billion.

New York-based Bristol-Myers faces one the starkest patent cliffs in the pharmaceutical industry, as four of its top five sellers lose patent protection between now and 2015. The company sells the schizophrenia drug Abilify and blood pressure medication Avapro, among other prescription medications.

French drugmaker Sanofi is already weathering its own revenue decline, after the FDA unexpectedly approved a generic version of its drug Lovenox, an injectable medication for preventing life-threatening blood clots.

Bristol-Myers studied in more than 900 infants born with a rare heart defect to see if the drug would reduce dangerous clotting. The study failed to show any benefit.

Drug companies routinely conduct such tests, even when success is not expected, to receive the six-month patent extension.

Explore further: Physicians warned about counterfeit medical devices

not rated yet
add to favorites email to friend print save as pdf

Related Stories

FDA says heartburn drugs can interfere with Plavix

Nov 17, 2009

(AP) -- Federal health officials said Tuesday a popular variety of heartburn medications can interfere with the blood thinner Plavix, a drug taken by millions of Americans to reduce risks of heart attack ...

FDA warning: some patients cannot process Plavix

Mar 12, 2010

(AP) -- The Food and Drug Administration is adding its strongest warning to the label for Plavix, cautioning that some patients do not respond to the blockbuster blood thinner.

FDA clears Eli Lilly's blood thinner Effient

Jul 10, 2009

(AP) -- The Food and Drug Administration on Friday approved a highly anticipated blood thinner from Eli Lilly, though the drug must carry the agency's sternest warning because of its bleeding risks.

Bristol-Myers Squibb sees 3Q profit dip 2 percent

Oct 26, 2010

(AP) -- Bristol-Myers Squibb Co. posted a slight decline in third-quarter profit Tuesday as its restrained spending was offset by flat sales of its drugs, lower income from its partners and bigger discounts to government ...

Pfizer gets EU approval for kids' cholesterol drug

Jul 06, 2010

(AP) -- The European Union has approved a new chewable form of cholesterol blockbuster Lipitor for children 10 and up with high levels of bad cholesterol and triglycerides, a type of blood fat, Pfizer said Tuesday.

Recommended for you

Physicians warned about counterfeit medical devices

just added

(HealthDay)—Physicians should be aware of the prevalence and serious consequences associated with use of counterfeit medical devices, according to a letter to the editor published online July 20 in Lasers in ...

Zydelig approved for three types of blood cancer

32 minutes ago

(HealthDay)—Zydelig (idelalisib) has been approved by the U.S. Food and Drug Administration to treat relapsed forms of blood cancer, including chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma (FL) ...

Journal raises concern about blood-thinning drug

13 hours ago

A medical journal raised concerns Wednesday about a blood-thinning drug widely used by people at risk of stroke, accusing its manufacturer of concealing safety data and regulators of laxness.

Supermaterial gives rejected drugs a new chance

Jul 22, 2014

More than 80 percent of all drug candidates in the pharma R&D suffer from poor solubility and are therefore rejected early in the drug discovery process. Now Uppsala University researchers show that the new ...

User comments : 1

Adjust slider to filter visible comments by rank

Display comments: newest first

CarolinaScotsman
not rated yet Jan 25, 2011
Of the seventeen medications I take, Plavix is the only non-generic. -Sigh- Guess I'll have to continue paying through the nose for a while longer.