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NDA

BIMATOPROST | N022369 | ABBVIE INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ALLERGAN, INC. et al v. HI-TECH PHARMACAL CO., INC. 1:2011cv00650 3 patentsANDA 203051Bimatoprost	NCMD	2011-08-17	Terminated 2013-01-25	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain13 active DMFs1 inactive

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

JOHNSON MATTHEY PHARMA SERVICESBIMATOPROST (3077.E)

DMF 209112007

CHIROGATE INTERNATIONAL INCBIMATOPROST

DMF 213822008

KYOWA PHARMA CHEMICAL CO LTDBIMATOPROST DRUG SUBSTANCE

DMF 216812008

EVERLIGHT CHEMICAL INDUSTRIAL CORPBIMATOPROST

DMF 220802008

INDUSTRIALE CHIMICA SRLBIMATOPROST

DMF 234802010

CAYMAN PHARMA SROBIMATOPROST

DMF 243532011

YS LIFE SCIENCE CO LTDBIMATOPROST

DMF 249062011

C-SQUARED PHARMA LTDBIMATOPROST

DMF 259032012

MSN LABORATORIES PRIVATE LTDBIMATOPROST [ROUTE CODE - "BM"]

DMF 270442013

SCINOPHARM TAIWAN LTDBIMATOPROST

DMF 272172013

EUROAPI HUNGARY LTDBIMATOPROST

DMF 295602015

FDC LTDBIMATOPROST USP

DMF 403502024

NEWCHEM SPABIMATOPROST

DMF 418902025

LUPIN LTDInactiveBIMATOPROST

DMF 268772013

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Aug 30, 2021	SUPPL -14	View Letter (PDF)
Sep 30, 2020	SUPPL -12	View Letter (PDF)
Aug 2, 2017	SUPPL -11	View Letter (PDF)
Sep 8, 2014	SUPPL -8	View Letter (PDF)
Sep 8, 2014	SUPPL -10	View Letter (PDF)
Sep 12, 2011	SUPPL -4	View Letter (PDF)
Dec 31, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.03%

RLDAT

0 patents0 exclusivities▴

SOLUTION/DROPS;TOPICAL | Approved: Dec 24, 2008

No patent or exclusivity listings for this strength.