AMRI is trying to stop India’s second-largest drug maker from pocketing millions from a generic form of anti-allergy drug Allegra expected to launch within the next 30 to 45 days.
AMRI filed a preliminary injunction against Dr. Reddy’s Laboratories in U.S. District Court for the District of New Jersey earlier this week in response to the March 17 decision by the U.S. Food and Drug Administration to allow Dr. Reddy’s to make a generic form of Allegra-D 24 Hour Extended Release Tablets.
“AMRI believes that the generic product of Dr. Reddy’s infringes on its intellectual property rights,” AMRI spokeswoman Andrea Schulz said in an e-mail.
The North American operations of French pharmaceutical maker Sanofi-aventis has joined AMRI in the injunction filing and is also part of AMRI’s existing patent infringement lawsuit against Dr. Reddy’s related to the manufacturing process for the active ingredient in various forms of Allegra filed in September.
Sanofi-aventis U.S. LLC is the exclusive licensee of multiple patents owned by AMRI relating to the manufacture of one of Allegra’s active ingredients, fexofenadine, according to Schulz. Sanofi-aventis is the company that markets Allegra D-24 as well as other Allegra products and is a successor to the company that brought Allegra to market.
The possible economic impact to AMRI as a result of the debut of an Allegra generic is unknown. But Dr. Reddy’s said last week it expects generic Allegra drug sales of $150 million to $200 million within three years.
Reports show Dr. Reddy’s also has first-to-file rights when the patent for Allegra D-24 expires in 2012, a status that can result in huge profits because of an exclusivity rule that prevents regulators from approving a similar generic within a 180-day period.
A spokesman for Dr. Reddy’s could not be reached for comment Wednesday.
AMRI, formerly Albany Molecular Research Inc., focuses on drug discovery and development projects along with creating active ingredients and chemicals for health care companies. Its royalty payments from sales of Allegra and generic forms of Allegra jumped 23 percent to $34.9 million in 2009. Overall sales were down 14 percent to $196.4 million last year, compared with 2008.
Experts say when a generic drug comes to market, the innovator drug company can lose up to 50 to 70 percent of its revenue.
According to Nathan Tinker, executive director of the New York Biotechnology Association, biopharmaceutical companies typically spend $700 million to $1 billion to bring a drug to market while investing research and capital over a 10- to 15-year period. Even with such a substantial investment, there is often little patent life left for the drug once it is brought to market, since patents last for only 20 years.
“Protecting that asset for as long as you can is in the interest of the innovator company,” Tinker said.
The Capital Region is home to at least 52 biopharmaceutical establishments that employ more than 16,000 people locally, according to NYBA, which lists companies like AMRI, AngioDynamics, and Taconic in the forefront of the region’s biopharmaceutical industry.
The area’s universities and hospitals make it an attractive place for clinical trials and ongoing studies related to drug development, NYBA said.
Tinker said generics, depending on how they are brought to market, can actually be beneficial for the company that developed the drug.
“It’s actually good for competition to have generics enter the marketplace and drive the innovators to greater levels of innovation. That said, the innovator companies have a clear right to recoup their costs and repay their investors and make sure they are making the money needed to reinvest in the next generation of drugs and pharmaceuticals,” Tinker said. “It’s a balancing act between the amount of time and money that goes into an original innovator drug and the time and expense of bringing a generic into competition with it.”