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MIFEPRISTONE

ANDA

MIFEPRISTONE | A211436 | TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: KORLYM(TE code: AB)

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
CORCEPT THERAPEUTICS, INC. v. TEVA PHARMACEUTICALS USA, INC. 1:2023cv01505 2 patentsANDA 211436mifepristone	D.N.J.	2023-03-17	Terminated 2023-05-15	—
CORCEPT THERAPEUTICS, INC. v. TEVA PHARMACEUTICALS USA, INC. et al 2:2019cv21384 1 patentANDA 211436mifepristone	D.N.J.	2019-12-13	Terminated 2020-03-27	—
CORCEPT THERAPEUTICS, INC. v. TEVA PHARMACEUTICALS USA, INC. et al 2:2019cv05066 3 patentsANDA 211436mifepristone	D.N.J.	2019-02-08	Terminated 2019-02-21	—

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

API Supply Chain5 active DMFs2 inactive

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

QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTDMIFEPRISTONE

DMF 246282011

FORMOSA LABORATORIES INCMIFEPRISTONE

DMF 274742013

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDMIFEPRISTONE

DMF 318732017

NAARI PTE LTDMIFEPRISTONE

DMF 371212022

CURIA SPAIN SAUMIFEPRISTONE MICRONIZED

DMF 372502022

PCASInactiveMIFEPRISTONE

DMF 205042007

ZHEJIANG XIANJU JUNYE PHARMACEUTICAL CO LTDInactiveMIFEPRISTONE

DMF 219442008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 18, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 3, 2020

No patent or exclusivity listings for this strength.