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Teva Reaches Compromise on Epinephrine Injector

Teva Reaches Compromise on Epinephrine Injector [Globes, Tel Aviv, Israel]

From Globes (Tel Aviv) (April 29, 2012)

April 29--Pfizer Inc. (NYSE: PFE) and Mylan Inc. (NYSE: MYL) have announced that Mylan subsidiary Meridian Medical Technologies Inc. has settled patent-infringement litigation with Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) over Teva’s generic version of the EpiPen device for injecting epinephrine during potentially fatal allergic reactions.

Under the settlement, Teva may begin marketing its version of the injector on June 22, 2015, or earlier under certain circumstances, provided that Teva obtains US Food and Drug Administration (FDA) approval.

Teva does not yet have FDA approval for its generic EpiPen injector, but the settlement settles the legal dispute over its Abbreviated New Drug Application (ANDA) filing with the FDA. Meridian manufactures the EpiPen for Pfizer, and Mylan markets it in the US.

Mylan and Pfizer added that additional details of settlement are confidential, and subject to review by the US Justice Department and the Federal Trade Commission.

In a separate statement, Antares Pharma Inc. (NYSE: AIS), a manufacturer of small-needle injector systems, announced that it will supply Teva with injectors, if needed, for 2013 and 2014, following FDA approval of Teva’s ANDA.

Teva’s share price was flat at NIS 171.20 in early trading on the TASE today, after remaining unchanged at $45.63 on Nasdaq on Friday, giving a market cap of $43 billion.


(c)2012 the Globes (Tel Aviv, Israel)

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Posted: April 2012