Mylan (MYL) Gains on Generic Concerta Approval

October 25, 2016 11:46 AM EDT
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Mylan (NASDAQ: MYL) is active today after AB-rated approval on generic Concerta (methylphenidate hydrochloride) per the FDA website 10/21.

RBC analyst Randall Stanicky notes this approval follows last week’s announcement by FDA that it would pursue removal of BX-rated versions sold by MNK and LCI (Kudco) which would effectively leave TEVA alone in the market (acquired via AGN).

However, per the firm's back and forth with MYL today, it is unclear when the company will‎ be able to launch as settlement terms with JNJ are undisclosed. Per JNJ's 10-k, it appears settlement was entered into around October 2015.

For TEVA (NASDQ: TEVA), they believe generic Concerta is ~$0.25 to EPS (4%) and an important product but one that we fully expect to see additional generic competition on and thus not a growth driver. ‎TEVA may see some incremental upside for a short period of time given the potential for (we think likely) removal of BX competitors per FDA last week who collectively had ~15% share combined (TEVA ~78%) - 11% (MNK) and 4% (LCI) share.

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