Mylan May Be the First to File Complete ANDA with Paragraph IV Certification for Copaxone 40



First to file complete ANDA with Paragraph IV certification

Mylan (MYL) believes that it may be the first generic pharmaceutical company to file a complete ANDA (abbreviated new drug application) with Paragraph IV certification for Teva Pharmaceutical’s (TEVA) Copaxone 40 mg/ml. If the five orange book patents related to this dosage of the drug are proved invalid, Mylan could enjoy 180-day marketing exclusivity for its generic version of the drug.

This exclusivity would depend on the FDA’s (Food and Drug Administration) approval of its ANDA—and on the FDA not approving any other generic version of the drug during the time frame. If this were to happen, it could boost Mylan’s share price as well as that of the iShares Nasdaq Biotechnology ETF (IBB). Notably, Mylan makes up about 4.1% of IBB’s total portfolio holdings.

The 180-day marketing exclusivity has been provided to incentivize generic players to challenge branded drug patents and enable the entry of cheaper drugs in the market. (To know more about paragraph IV certification, please refer Is a Para IV Filing Rewarding for a Generic Company?)

Article continues below advertisement

Analyst recommendations

The potential positive news can be seen in Mylan’s analyst recommendations on August 24, 2016, and August 25, 2016. Based on Bloomberg survey of 24 brokerage firms, Mylan received “buy” recommendations from 59.1% of analysts and “hold” recommendations from 40.9%. The 12-month target price for the company is projected at ~$58.08, which represents a rise of 31.9% from the stock’s price of $44.03 on August 24, 2016.

Notably, Peers Pfizer (PFE) and Akorn (AKRX) hold “buy” recommendations from 57.7% and 62.5% of the surveyed analysts, respectively.


More From Market Realist