Report: Drug stores may benefit from patent expiries

   

By Alaric DeArment

NEW YORK (Feb. 8) Patent expiries on blockbuster branded drugs could mean huge profits for some retail pharmacy chains, according to published reports.

Bloomberg quoted investors as saying that CVS and Walgreens could see at least a 20% increase in profits as drugs with more than $100 billion in sales, such as Pfizer’s Lipitor (atorvastatin calcium) and Sanofi-Aventis’ and Bristol-Myers Squibb’s Plavix (clopidogrel bisulfate), face generic competition, particularly between 2011 and 2013.

Lipitor and Plavix were the first and third top-selling branded drugs in 2008, with respective U.S. sales of $7.8 billion and $4.9 billion, according to IMS Health.

CVS CFO Dave Denton reportedly said that it's too early to make predictions because profits will be determined by pricing, and prices are unknown. "The generic pipeline is robust," Denton said in an interview with Bloomberg. "The percentage boost is not something we have analyzed to that level of depth. Pricing is very competitive and we can?t know for sure what it will look like at that time."

Echoing that sentiment, Wade Miquelon, Walgreens CFO, was quoted as saying, Generic drugs "will definitely help us, but to that magnitude, considering there are other things that play in, I would hesitate to give any guidance. There are lots of moving parts in this business and different people factor them in different ways."

Amneal receives FDA approval for generic painkiller

   

By Alaric DeArment

HAUPPAUGE, N.Y. (Feb. 8) Amneal Pharmaceuticals has received approval from the Food and Drug Administration to manufacture a generic version of a painkiller made by Johnson & Johnson, the generic drug maker announced Monday.

Amneal said the FDA had approves its generic tramadol/acetaminophen tablets in the 37.5-mg/325-mg strength. The drug is a generic version of Ultracet, made by J&J subsidiary Ortho-McNeil Janssen. Ultracet had sales of $61 million, according to IMS Health data from June 2009.

The drug is used for short-term treatment of moderately severe acute pain and is a controlled substance in some states. The company began shipping the tablets, made at its Hauppauge, N.Y., plant, on Jan. 25.

“Tramadol/APAP is a logical extension of our well-established tramadol line, which enjoys a solid market share in the industry,” Amneal EVP sales and marketing Jim Luce said. “Our total commitment to rapidly expanding our product portfolio, manufacturing the highest-quality products and delivering outstanding customer service combined to power Amneal’s prescription growth of 114% from 2008 to 2009, the highest in the generics industry, according to IMS Health.”

Pfizer files infringement suit against Mylan for Caduet generic

   

By Alaric DeArment

PITTSBURGH (Feb. 4) Pfizer has filed a lawsuit against Mylan following a challenge to its patent for a cardiovascular drug, Mylan said Thursday.Pfizer has filed a lawsuit against Mylan following a challenge to its patent for a cardiovascular drug, Mylan said Thursday.

Pfizer filed a lawsuit in the U.S. District Court for the District of Delaware after Mylan filed for regulatory approval of a generic version of Caduet (amlodipine besylate and atorvastatin calcium). Mylan said it was the first company to file for approval of a generic version of Caduet, which entitles it to six months’ market exclusivity in which to compete directly with the branded drug after Pfizer’s patents expire.

Mylan seeks approval for the drug in the 2.5-mg/10-mg, 2.5-mg/20-mg, 2.5-mg/40-mg, 5-mg/10-mg, 5-mg/20-mg, 5-mg/40-mg 5-mg/80-mg, 10-mg/10-mg, 10-mg/20-mg, 10-mg/40-mg and 10-mg/80-mg strengths.

Caduet had sales of about $65.6 million for the 2.5-mg/10-mg, 2.5-mg/20-mg, 2.5-mg/40-mg and 10-mg/40-mg strengths in 2009, according to IMS Health.