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Asset purchase agreement for Zenchent Fe, norethindrone acetate/ethinyl estradiol and risedronate sodium

Companies: Amneal Pharmaceuticals
Allergan (name changed from Actavis)
Announcement date: Sep 30 2013
Related contracts: Acquisition agreement for Warner Chilcott

Details

Announcement date: Sep 30 2013
Industry sectors: Bigpharma
Generic pharma
Brand name: Zenchent Fe
Compound name: norethindrone acetate/ethinyl estradiol,norethindrone acetate/ethinyl estradiol, risedronate sodium, norethindrone acetate/ethinyl estradiol
Asset type: Product
Therapy areas: Sexual Health » Contraception
Technology types: Drug delivery » Oral delivery
Small molecules
Deal components: Asset purchase
Stages of development: Regulatory
Marketed

Financials

Termsheet

Amneal Pharmaceuticals has entered into agreements with subsidiaries of Actavis, Inc. to purchase four generic products for cash consideration.

One product is currently marketed in the U.S. by Actavis, two products have Abbreviated New Drug Applications currently awaiting regulatory approval, and one product has been approved but is not currently marketed pursuant to a settlement agreement.

The closings of the purchase agreements are contingent upon the consummation of Actavis’ acquisition of Warner Chilcott plc.

The product currently marketed is Zenchent Fe (norethindrone acetate/ethinyl estradiol), the generic version of Femcon Fe.

The two products awaiting regulatory approval are norethindrone acetate/ethinyl estradiol, the generic version of Lo Loestrin Fe; and risedronate sodium, the generic version of Atelvia.

The generic product approved but not currently marketed is norethindrone acetate/ethinyl estradiol, the generic equivalent of Loestrin 24 Fe.

Press Release

Amneal Pharmaceuticals to Acquire Four Generic Products

Purchase of Products to be Completed Following Close of Actavis Acquisition of Warner Chilcott

BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, LLC (“Amneal”), the 7th largest generic drug manufacturer in the U.S., announced today that it has entered into agreements with subsidiaries of Actavis, Inc. (NYSE:ACT) to purchase four generic products for cash consideration. One product is currently marketed in the U.S. by Actavis, two products have Abbreviated New Drug Applications currently awaiting regulatory approval, and one product has been approved but is not currently marketed pursuant to a settlement agreement. The closings of the purchase agreements are contingent upon the consummation of Actavis’ acquisition of Warner Chilcott plc.

The product currently marketed is Zenchent Fe™ (norethindrone acetate/ethinyl estradiol), the generic version of Femcon Fe™. Amneal expects to begin shipping Zenchent Fe immediately following the closing of the acquisition. The two products awaiting regulatory approval are norethindrone acetate/ethinyl estradiol, the generic version of Lo Loestrin® Fe; and risedronate sodium, the generic version of Atelvia®. The generic product approved but not currently marketed is norethindrone acetate/ethinyl estradiol, the generic equivalent of Loestrin® 24 Fe.

Please click here to see the full prescribing information for Zenchent Fe™.

About Amneal Pharmaceuticals, LLC

Headquartered in Bridgewater, New Jersey, Amneal Pharmaceuticals, LLC is a U.S.-based developer and manufacturer of high quality FDA-approved generic pharmaceuticals. The Company owns and operates manufacturing, R&D, packaging, sales and distribution facilities throughout the U.S. and abroad. Amneal prides itself on an unwavering commitment to quality, reliability and innovative approaches to maximizing value for all stakeholders. Amneal’s impressive growth has been spurred by extensive investment in R&D, intelligent product selection, aggressive geographic expansion and a vertically integrated strategy. For more information, visit amneal.com.

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Contract

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