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LOGILIA

ANDA

ULIPRISTAL ACETATE | A207952 | TEVA PHARMACEUTICALS USA

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ELLA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Laboratoire HRA Pharma v. Teva Pharmaceuticals USA Inc. 1:2015cv00045 3 patentsANDA 207952ulipristal acetate	D. Del.	2015-01-16	Terminated 2016-08-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain5 active DMFs1 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

CURIA SPAIN SAUULIPRISTAL ACETATE MICRONIZED

DMF 215272008

FORMOSA LABORATORIES INCULIPRISTAL ACETATE

DMF 257012012

TAPI NL BVULIPRISTAL ACETATE

DMF 279452014

NEWCHEM SPAULIPRISTAL ACETATE

DMF 322342017

INDUSTRIALE CHIMICA SRLULIPRISTAL ACETATE

DMF 329542018

GEDEON RICHTER PLCInactiveULIPRISTAL ACETATE MICRONIZED

DMF 268612013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 15, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 30MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 13, 2017

No patent or exclusivity listings for this strength.