The makers of the Xarelto drug have filed a lawsuit for patent infringement cases. Janssen Pharmaceuticals and Bayer A.G. have filed a lawsuit against the company Brecenridge Pharmaceutical, alleging that the company has tried to infringe on the Xarelto patent. Bayer is the maker of the anticoagulant in most countries; also Janssen makes it in the U.S.
Breckenridge has filed an Abbreviated New Drug Application with the FDA, which is for a generic version of the anticoagulant. Both Bayer and Janssen believe that as soon as the application is approved, Breckenridge will release their generic version of the drug. The existing patent for Xarelto, however, will not expire until the end of the year 2020.
The accusations of patent infringement cases were based on reasons, since Boehringer Ingelheim, the makers of Pradaxa, sued Brekenridge when they filed an ANDA for a generic version of Pradaxa two years ago. There are concerns that the company is too eager to enter into the anticoagulant market, and that it is throwing patent rights out of the window because of its enthusiasm.
Xarelto and Pradaxa are both big moneymakers, but there are a lot of problems with the drugs. There are lawsuits plaguing both of the medications, and concerns that Pradaxa could have some serious side-effects. Patients who experience uncontrolled bleeding, however, say that Boehringer Ingelheim did not give them sufficient warning of the risks. The company was ordered to pay out $650 million as settlements for lawsuits because of these side effects.
Xarelto is the subject of similar patent infringement cases, with Bayer and Janssen likely facing significant financial penalties because of the 6,000 lawsuits against it – which may be worse because there is no antidote, and the bleeding events can be life-threatening.
The generic version of the drug could escape some of the legal liabilities, since the makers of generics are not required to update their warnings when brand-name drugs change their warnings. They have the choice about whether or not they need to update their packaging to reflect changes.
The generic makers have limited liability because of the restrictions on them. For consumers, this means that they do not have so many rights to hold the generic makers responsible for their drugs. Janssen and Bayer, however, are not eager to hand over the rights to the drugs.
The FDA reports that there were more than 10,600 reports relating to adverse events after taking Xarelto in 2015, and that included 1,121 deaths and 4,508 injuries severe enough to require emergency treatment or hospitalisation. Xarelto is one of the poorest ranked drugs in terms of requiring hospitalization.
Xarelto is used in a lot of different scenarios, and the number of patent infringement cases is growing and growing. There will be a trial in March 2017, and it is expected that by then there could be more than 10,000 outstanding Xarelto lawsuits. Plaintiffs say that the makers misrepresented the drug. The initial approval was controversial. The manufacturers will, naturally, want to avoid a scenario of a third party getting approval for a less-risky generic version.