Endo International plc’s 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 - Free Report) , Bristol-Myers Squibb Company (BMY - Free Report) and Retrophin, Inc. . All three stocks sport a Zacks Rank #1 (Strong Buy).
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Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
Endo International plc’s 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 - Free Report) , Bristol-Myers Squibb Company (BMY - Free Report) and Retrophin, Inc. . All three stocks sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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