Endo International plc – Ordinary Shares (NASDAQ:ENDP) announced that one of its operating companies, Par Pharmaceutical, has been issued a new patent by the U.S. Patent and Trademark Office (PTO) relating to Vasostrict® (vasopressin injection, USP) 20 units/mL. The PTO has issued to Par U.S. Patent No. 9,375,478, which has an expiration date of January 30, 2035. Patent No. 9,375,478 has been submitted to the U.S. Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, and will have a submission date of June 28, 2016.
This Orange Book listing requires any Abbreviated New Drug Application (ANDA) applicant seeking FDA approval for a generic version of Vasostrict® prior to expiration of the patent to notify Par of its ANDA filing before it can obtain FDA approval. Any ANDA filer whose application was not received prior to submission of the new patent information would be subject to a 30-month stay of marketing approval by the FDAupon the initiation of Hatch-Waxman litigation by Par against the ANDA filer.
Par’s Vasostrict® is the first and only vasopressin injection, USP, product approved by the FDA. Vasostrict® is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. Under the FDA’s unapproved drugs initiative, Par invested significant time and resources to demonstrate the safety and efficacy of its reformulated and improved Vasostrict® product and to obtain FDA approval. Par continues to invest in its sterile injectables manufacturing facility and has proven to be a reliable supplier of high-quality, high-purity products. (Original Source)
As of this writing, shares of Endo are up nearly 15% to $15.67. ENDP has a 1-year high of $88.54 and a 1-year low of $12.56. The stock’s 50-day moving average is $15.83 and its 200-day moving average is $36.88.
On the ratings front, Endo has been the subject of a number of recent research reports. In a report issued on June 14, UBS analyst Marc Goodman maintained a Buy rating on ENDP, with a price target of $30, which represents a potential upside of 113.5% from where the stock is currently trading. Separately, on June 13, Mizuho’s Irina Rivkind Koffler upgraded the stock to Hold and has a price target of $16.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Marc Goodman and Irina Rivkind Koffler have a total average return of -1.5% and 23.9% respectively. Goodman has a success rate of 44% and is ranked #2843 out of 3967 analysts, while Koffler has a success rate of 53% and is ranked #11.
The street is mostly Neutral on ENDP stock. Out of 13 analysts who cover the stock, 8 suggest a Hold rating and 5 recommend to Buy the stock. The 12-month average price target assigned to the stock is $22.25, which implies an upside of 58% from current levels.
Endo International Plc operates as a pharmaceutical company. It focuses on developing, manufacturing, and distributing of branded and generic pharmaceutical products. The company was founded on October 31, 2013 and is headquartered Dublin, Ireland.