pharmafileMarch 05, 2018
Tag: Endo , blood pressure
Generics and speciality pharma firm Endo International has revealed that it has been granted a preliminary injunction to block competitor QuVa from marketing a compounded vasopressin product which Endo claims "misappropriates" trade secrets related to its own blood pressure injection Vasostrict.
Vasotrict was approved by the FDA in 2014 as a therapy to increase blood pressure in adult patients, becoming the first and only vasopressin injection authorised by the US regulator.
"Endo embraces principles of fair competition. In fact, our competitors keep us striving to improve our products and services," remarked Matthew J Maletta, Executive Vice President and Chief Legal Officer of Endo. "That said, fair competition does not extend to the misappropriation of our valuable information. We initiated this litigation because we have a responsibility to protect our Company and prevent other parties from obtaining an improper and unfair advantage in the marketplace. We look forward to pursuing this case through trial where we will seek permanent injunctive relief, together with the recovery of all appropriate damages from QuVa, the individual defendants and potentially other parties not yet named in the litigation."
Endo had also launched legal action against the FDA itself which alleged that the agency improperly authorised bulk compounding of hundreds of drugs which included what it called "essentially a copy" of its Vasotrict product. It has since withdrawn the lawsuit.
Bulk compounding has become increasingly prevalent in the US since the FDA’s passing of a law in 2013 which permitted outsourcing facilities who registered with the agency to sell tailored drug doses in bulk without prescriptions, so long as they complied with federal manufacturing standards. The regulator recently announced plans to issue new guidance on which substances can be utilised in the bulk production of drugs for doctor’s offices and hospitals with individual prescriptions, with the criteria expected to be released this month.
Contact Us
Tel: (+86) 400 610 1188
WhatsApp/Telegram/Wechat: +86 13621645194
Follow Us: