Mylan N.V. MYL announced that the U.S. Patent and Trademark Appeal Board (“PTAB”) has instituted inter partes review (“IPR”) proceedings on all claims against two Orange Book-listed patents — U.S. Patent Nos. 7,476,652 and 7,713,930, respectively.
The two patents are owned by Sanofi SNY for Lantus (insulin glargine injection) 100 Units/mL.
We remind investors that Mylan's 505(b)(2) new drug application (“NDA”) for Insulin Glargine in vial and pen dosage forms is under active review with the FDA.
In October, Sanofi initiated a patent infringement litigation against Mylan's NDA in the United States District Court for the District of New Jersey alleging violation of 18 patents in the suit inclusive of these two Lantus patents.
Lantus and Lantus Solostar are both approved for improving glycemic control in adult patients with diabetes mellitus.
Sanofi’s diabetes franchise seems highly weighed on with its key product Lantus facing a tremendous competitive pressure at the payor level as well as from other biosimilars in several European markets besides Japan. Moreover, a biosimilar version of Lantus had hit the markets last December.
Meanwhile, shares of Mylan have rallied 4.9% so far this year, outperforming the industry’s 26.7% decline during the period.
Mylan is a leading generic drug company in terms of both total and new prescriptions. The company’s pursuit of first-to-file opportunities should help it maintain a strong position in the global generics market.
Mylan is also exploring the world of biosimilars, a market with potential to grow to $20 billion by 2020. A partnership with Biocon and collaborations with Momenta Pharmaceuticals, Inc. MNTA and Mabion have aided the company to develop a portfolio of 16 biosimilar/insulin analog generic products.
However, Mylan’s performance in 2017 continues to be affected by the ongoing challenges in North America. The third quarter witnessed a fast decline in EpiPen sales, thanks to the launch of an authorized generic as well as the contraction of overall epinephrine auto-injector market.
In a major boost, Mylan also received an FDA approval for the generic version of Copaxone 40mg. As one of the first filers, the company will enjoy 180 days of exclusivity. The recent FDA approval for Mylan’s biosimilar version of Roche Holdings’ RHHBY Herceptin will also boost the company’s biosimilar portfolio.
Mylan carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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