Yahoo Finance Mylan (MYL) Gets FDA Approval for Generic Copaxone 40mg
Mylan N.V. MYL announced that the FDA has approved Abbreviated New Drug Applications (ANDAs) for the generic version of Teva Pharmaceutical Industries Limited’s TEVA multiple sclerosis (MS) drug Copaxone (glatiramer acetate) 40 mg/mL (thrice weekly).
Notably, this is the first generic of Copaxone that has been approved.
The FDA also approved a generic for Copaxone 20 mg/mL Once-Daily.
Since Mylan was one of the first applicants to submit a substantially complete ANDA for glatiramer acetate Injection, 40 mg/mL, containing a Paragraph IV certification, the company and other first filers may be eligible for 180 days of generic drug exclusivity.
According to QuintilesIMS, sales of Copaxone 20mg/mL dose was approximately $700 million and $3.64 billion for the 40 mg/mL dose for the 12 months period ending July 31, 2017. Hence, the generic approval is expected to provide a significant boost to Mylan. Moreover, approximately 400,000 or 85% individuals in the United States suffer from MS and relapsing MS.
The news is expected to relieve investors. Mylan’s stock has fallen 16.2% in the last six months compared with the industry’s decline of 16.5%. Mylan continues to face challenges in North America and uncertain regulatory environment in the region which has led the company to defer all major launches in the United States from 2017 to 2018.
Mylan currently has 225 ANDAs pending FDA approval. 44 of these pending ANDAs are potential first-to-file opportunities. However, the company suffered a blow when the FDA issued a complete response letter to its ANDA for generic version of GlaxoSmithKline’s plc GSK asthma drug Advair Diskus. Advair recorded sales of £1.8 billion in 2016. The company believes approval delays will persist in 2017 thereby impacting business further. The company believes that increased competition resulting from the FDA's focus on accelerating the approvals of third, fourth, or fifth generics will also impact sales.
Meanwhile, Momenta Pharmaceuticals, Inc. MNTA along with Sandoz is looking to get approval for their generic version (Glatopa 40 mg) of 40-mg thrice-weekly formulation of Copaxone. Momenta’s sales of Glatopa 20mg continue to do well and have already captured approximately 40% of the market in the United States.
Zacks Rank
Mylan currently carries a Zacks Rank #5 (Strong Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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