Courtney Jorstad  |  January 13, 2014

Category: Legal News

Top Class Actions’s website and social media posts use affiliate links. If you make a purchase using such links, we may receive a commission, but it will not result in any additional charges to you. Please review our Affiliate Link Disclosure for more information.

AggrenoxAmerican Sales Company LLC, a drug distributor, has filed an anti-trust class action lawsuit against Boehringer Ingelheim Pharma and Teva Pharmaceuticals for allegedly excluding generic drug companies from selling a generic version of the anti-stroke drug Aggrenox, saying that Boehringer has a pay-for-delay deal with Teva to keep the pharmaceutical company from developing a generic version of the drug that would compete with Aggrenox’s profits.

As a result, American Sales claims that it had to pay top dollar for the stroke medication, when it could have paid less if it were given the option to buy a generic version of the drug. American Sales is joining Miami-Luken Inc., which filed a class action lawsuit against Boehringer over the pay-for-delay arrangement with Teva in November.

“To avoid the loss of its Aggrenox monopoly profits, Boehringer engineered a scheme with Barr (later acquired by Teva) whereby Boehringer began paying Barr for Barr’s agreement to drop its challenge to Boehringer’s ‘577 patent and delay the introduction and sales of Barr’s lower-priced generic version of Aggrenox,” American Sales claims in the class action lawsuit.

Aggrenox is prescribe to treat patients who at risk of having a stroke. It is made by Boehringer and is a combination of 200 mg extended release dipyridamole and 25 mg acetylsalicylic acid.

“Since Aggrenox’s approval by the Food and Drug Administration (FDA) in 1999, Boehringer has been able to charge monopoly prices (and earn monopoly profits) on Aggrenox,” the class action lawsuit claims. “By 2008, Aggrenox had U.S. sales of approximately $366 million, which rose to approximately $404 million in 2009.”

According to the lawsuit, Barr (which is now Teva) was seeking approval from the FDA in May 2007 to create a generic version of Aggrenox when Teva was sued by Boehringer alleging that Teva was infringing on Boehringer’s “577 patent,” which is set to expire in January 2017. This move by Boehringer “triggered an automatic stay of the FDA’s approval of Barr’s generic product that could last up to 30 months.”

In the course of the patent suit by Barr, it presented “a series of defenses that seriously threatened to invalidate Boehringer’s 577 patent.”

According to American Sales’ lawsuit, Boehringer struck a deal with Barr, agreeing to pay the generic drug company $120 million over seven years as long as Barr agreed to delay launching a generic version of Aggrenox until 2015.

In exchange, Barr agreed to help promote Aggrenox to obstetricians and gynecologists, even though it would be little use to doctors in those fields.

“The agreement also provided that when the negotiated period of delay expired, Barr could market an authorized generic version of Aggrenox,” the suit claims. “Barr could thereby avoid competition from an authorized generic marketed by Boehringer, or another licensee of Boehringer, and guarantee higher profits than it could make on its own generic product in competition with an authorized generic.”

American Sales alleges that the co-promotion deal “was a pretext for a series of ongoing payments to Barr for entering into, and perpetuating, an unlawful market allocation agreement pursuant to which Barr agreed not to compete with Boehringer until July 2015 in exchange for a continuing share of Boehringer’s monopoly profits from the sale of branded Aggrenox during this time and higher profits selling the authorized generic.”

The drug distributer cites an investigation into the deal by the Federal Trade Commission in which Boehringer admitted that the payments made to Barr were linked to the litigation settlement. The federal agency also discovered “that the co-promotion deal was an ‘integral’ part of the settlement.”

There have been more lawsuits over such deals, which got a boost when the Supreme Court said that in some cases such arrangements are illegal.

American Sales is represented by Gerald C. Pia Jr. and Brian C. Roche of Roche Pia LLC and Thomas M. Sobol, David S. Nalven and Edward Notargiacomo of Hagens Berman Sobol Shapiro LLP.

There is no attorney information for Boehringer and Teva at this time.

The Aggrenox Pricing Class Action Lawsuit is American Sales Co. LLC v. Boehringer Ingelheim Pharma GMBH & Co. KG, et al., Case No. 3:14-cv-00003, in the U.S. District Court for the District of Connecticut.

We tell you about cash you can claim EVERY WEEK! Sign up for our free newsletter.


Leave a Reply

Your email address will not be published. By submitting your comment and contact information, you agree to receive marketing emails from Top Class Actions regarding this and/or similar lawsuits or settlements, and/or to be contacted by an attorney or law firm to discuss the details of your potential case at no charge to you if you qualify. Required fields are marked *

Please note: Top Class Actions is not a settlement administrator or law firm. Top Class Actions is a legal news source that reports on class action lawsuits, class action settlements, drug injury lawsuits and product liability lawsuits. Top Class Actions does not process claims and we cannot advise you on the status of any class action settlement claim. You must contact the settlement administrator or your attorney for any updates regarding your claim status, claim form or questions about when payments are expected to be mailed out.