Viewing data from:

ALTACE

NDA

RAMIPRIL | N019901 | KING PHARMACEUTICALS LLC

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
King Pharmaceuticals - Citizen Petition FDA-2008-P-0304 · 3 docket documents King Pharmaceuticals, Inc. filed this citizen petition on May 16, 2008, requesting that FDA confirm it will ensure generic ramipril products approved under ANDA applications referencing Altace include complete cardiovascular outcomes labeling information from the HOPE trial regarding reduction of ri	505(q)	2008-06-04	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

138 trials from ClinicalTrials.gov — 4 recruiting, 1 active, 104 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Explorative Study for Treating Persistent Developmental Stuttering With Ramipril NCT04173949	Phase 3	Active	HaEmek Medical Center, Israel	10	2020-03-15 → 2025-12-30
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis NCT02842424	Phase 4	Recruiting	University of Nebraska	70	2016-02-25 → 2026-06
NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients NCT02817360	Phase 4	Recruiting	Martin Huelsmann	2,400	2016-02 → 2026-12
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
Effect of Some Drugs on Liver Fibrosis NCT03770936	Phase 3	Recruiting	Sherief Abd-Elsalam	45	2018-10-01 → 2027-11
Ramipril - Hypertension NCT00325806	Phase 4	Completed	Sanofi	1,008	2000-05 → 2005-08
Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria NCT00095290	Phase 4	Completed	Bristol-Myers Squibb	400	2004-09 → 2005-11
Nephropathy In Type 2 Diabetes and Cardio-renal Events NCT00535925	Phase 4	Completed	University of Campania Luigi Vanvitelli	850	2005-10 → 2019-05
A Relative Bioavailability Study of Ramipril 10 mg Capsules Administered Orally as a Sprinkle on Applesauce NCT00863915	Phase 1	Completed	Actavis Inc.	40	2004-10 → 2004-10
Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE)NCT00054938	Phase 2	Completed	Brigham and Women's Hospital	150	2003-03 → 2005-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Altace (2024)

Total Spending

$1.2M

Total Claims

1,888

Beneficiaries

420

Avg Cost/Unit

$6.96

Spending Trend

$5.2M(2019)→$4.7M(2020)→$3.8M(2021)→$2.2M(2022)→$1.7M(2023)→$1.2M(2024)

YoY Change:-2.0%

5yr CAGR:+1.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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

18 letters from Drugs@FDA

Date	Submission	Document
May 11, 2026	SUPPL -72	View Letter (PDF)
May 2, 2017	SUPPL -67	View Letter (PDF)
Sep 14, 2015	SUPPL -65	View Letter (PDF)
May 6, 2014	SUPPL -64	View Letter (PDF)
Nov 6, 2013	SUPPL -62	View Letter (PDF)
Oct 28, 2013	SUPPL -63	View Letter (PDF)
Sep 24, 2013	SUPPL -60	View Letter (PDF)
Apr 16, 2012	SUPPL -59	View Letter (PDF)
Aug 26, 2011	SUPPL -58	View Letter (PDF)
Oct 25, 2010	SUPPL -55	View Letter (PDF)
Mar 6, 2009	SUPPL -52	View Letter (PDF)
Feb 18, 2009	SUPPL -54	View Letter (PDF)
Nov 16, 2004	SUPPL -46	View Letter (PDF)
Oct 22, 2004	SUPPL -40	View Letter (PDF)
Oct 22, 2004	SUPPL -43	View Letter (PDF)
Oct 22, 2004	SUPPL -41	View Letter (PDF)
Aug 2, 2002	SUPPL -34	View Letter (PDF)
Jul 10, 2002	SUPPL -35	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 1.25MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 28, 1991

No patent or exclusivity listings for this strength.

#002 — 2.5MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 28, 1991

#003 — 5MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 28, 1991

#004 — 10MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 28, 1991