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Re: DewDiligence post# 213505

Thursday, 10/12/2017 6:54:16 PM

Thursday, October 12, 2017 6:54:16 PM

Post# of 257269
AGN,PFE settle Restasis-patent litigation—allowing 2024 US launch of generic Restasis by PFE:

http://www.prnewswire.com/news-releases/allergan-announces-settlement-on-restasis-cyclosporine-ophthalmic-emulsion-005-patent-litigation-with-innopharma-inc-300536066.html

Pursuant to the terms of the settlement, Allergan will grant InnoPharma licenses to market a generic version of RESTASIS in the United States beginning on February 24, 2024, or earlier under certain circumstances.

Additionally, under certain circumstances, Allergan will supply and authorize InnoPharma to launch an authorized generic version of RESTASIS on August 28, 2024. Additional details regarding the settlement were not disclosed.

InnoPharma is a unit of PFE, the result of a 2014 acquisition (#msg-104352638).

Three companies other than PFE who have filed paragraph-IV challenges on Restasis—TEVA, MYL, and AKRX—have not (yet) settled with AGN.

The provision in the PR above regarding the launch of an authorized generic is presumably triggered if a company other than PFE launches its own generic Restasis.

Restasis is AGN’s second-largest product (after Botox).

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