Endo International plc’s ENDP shares jumped 18.3% after the company announced that the U.S. Patent and Trademark Office (PTO) has issued a new patent (U.S. Patent No. 9,375,478) for a drug, Vasostrict (vasopressin injection, USP) 20 units/mL, belonging to one of its operating companies, Par Pharmaceutical.
The patent, which has an expiration date of Jan 30, 2035, has been submitted to the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
We note that this Orange Book listing will require a generic drug maker seeking FDA approval for a generic version of Vasostrict prior to the expiration of the patent to notify Par of its abbreviation new drug application (ANDA). Any ANDA filer whose application was not received prior to the submission of the new patent information would be subject to a 30-month stay of marketing approval by the FDA upon the initiation of Hatch-Waxman litigation by Par against the ANDA filer.
Vasostrict is the first and only vasopressin injection, USP, product to be approved by the FDA to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.
We remind investors that Endo acquired Par Pharmaceutical in Sep 2015. The acquisition boosted Endo’s generics portfolio and pipeline.
Endo is a Zack Rank #5 (Strong Sell) stock. Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. ANIP, Bristol-Myers Squibb Company BMY and Retrophin, Inc. RTRX. All three stocks sport a Zacks Rank #1 (Strong Buy).
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