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ALTACE

NDA

RAMIPRIL | N022021 | KING PHARMACEUTICALS INC SUB PFIZER INC

4 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain11 active DMFs8 inactive

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

EUROAPI GERMANY GMBHRAMIPRIL

DMF 152082000

DR REDDYS LABORATORIES LTDRAMIPRIL USP

DMF 161932002

NEULAND LABORATORIES LTDRAMIPRIL USP

DMF 166472003

CIPLA LTDRAMIPRIL USP

DMF 170332003

APITORIA PHARMA PRIVATE LTDRAMIPRIL USP

DMF 175702004

LUPIN LTDRAMIPRIL USP

DMF 180242005

HETERO LABS LTDRAMIPRIL

DMF 183382004

UNIMARK REMEDIES LTDRAMIPRIL USP

DMF 195222006

AARTI PHARMALABS LTDRAMIPRIL USP (GRADE A)

DMF 197142006

APOTEX PHARMACHEM INDIA PVT LTDRAMIPRIL USP

DMF 207132007

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDRAMIPRIL USP

DMF 246502011

ESTEVE QUIMICA SAInactiveRAMIPRIL

DMF 169002003

SMS PHARMACEUTICALS LTDInactiveRAMIPRIL

DMF 174012004

LUPIN LTDInactiveRAMIPRIL USP (PROCESS B)

DMF 179562004

AARTI INDUSTRIES LTDInactiveRAMIPRIL USP, GRADE II

DMF 197192006

RANBAXY LABORATORIES LTDInactiveRAMIPRIL

DMF 203802007

WATSON PHARMA PRIVATE LTDInactiveRAMIPRIL USP

DMF 214022008

MELODY HEALTHCARE PVT LTDInactiveRAMIPRIL

DMF 238852010

EUROAPI GERMANY GMBHInactiveRAMIPRIL (PROCESS 2)

DMF 375062022

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jan 23, 2012	SUPPL -8	View Letter (PDF)
Aug 8, 2011	SUPPL -7	View Letter (PDF)
Jan 20, 2010	SUPPL -6	View Letter (PDF)
Mar 6, 2009	SUPPL -1	View Letter (PDF)
Feb 18, 2009	SUPPL -5	View Letter (PDF)
Mar 7, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 27, 2007

No patent or exclusivity listings for this strength.

#002 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 27, 2007

#003 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 27, 2007

#004 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 27, 2007