Pharma major AstraZeneca has filed a petition in a US court, alleging that Aurobindo Pharma is attempting to come out with the generic version of its patented drug Daliresp (Roflumilast Tablet 500 mcg).
In a petition filed in the United States District Court for the District Court of New Jersey on 15 May, AstraZeneca alleged that the Indian drug makers proposed generic Daliresp would infringe the patents on three counts and requested the court to pass an injunction order against manufacturing, importing and selling that drug in the USA.
Daliresp isis a prescription medicine used in adults with severe Chronic Obstructive Pulmonary Disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms (exacerbations).
AstraZeneca prayed for a permanent injunction, restraining and enjoining Aurobindo Pharma from making, using, selling, offering to sell, or importing any product that infringes the 206, 064, and 142 Patent, including the product (Dalisrep).
AstraZeneca Pharmaceuticals LP is the current holder of New Drug Application for Daliresp (Roflumilast) Tablet 500 mcg, which was first approved by the Food and Drug Administration on 28 February 2011.
Aurobindo Pharma wrote to AstraZeneca Pharmaceuticals LP and AstraZeneca AB on 5 April, 2019 (Notice Letter), saying they had submitted US FDA an Abbreviated New Drug Application (ANDA ) with paragraph IV certifications for the 206, 064, and 142 Patents, the petition said.
Under this, a company can seek FDA approval to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy.
A city-based pharmaceutical company senior official said patent infringement cases are not uncommon for generic drug makers in USA and the lawsuit would not have any implications on the company’s performance.