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NDA

MOEXIPRIL HYDROCHLORIDE | N020312 | UCB INC

2 strengths0 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
Apotex, Inc. et al v. UCB, Inc. et al 0:2012cv60706 1 patentmoexipril	S.D. Fla.	2012-04-20	Terminated 2013-09-19	—

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 Chain2 active DMFs4 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

APOTEX INCMOEXIPRIL HYDROCHLORIDE USP

DMF 191132006

ALIVUS LIFE SCIENCES LTDMOEXIPRIL HYDROCHLORIDE USP

DMF 204262007

PCASInactiveMOEXIPRIL HYDROCHLORIDE

DMF 99421992

ORGAMOL SAInactiveMOEXIPRIL HYDROCHLORIDE

DMF 105201993

ESTEVE QUIMICA SAInactiveMOEXIPRIL HYDROCHLORIDE

DMF 151722000

UCB MANUFACTURING IRELAND LTDInactiveMOEXIPRIL HYDROCHLORIDE

DMF 166702003

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

Approval Letters

6 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 19, 1995

No patent or exclusivity listings for this strength.

#002 — 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 19, 1995