Viewing data from:

VASOTEC

NDA

ENALAPRIL MALEATE | N018998 | BAUSCH HEALTH US 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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AZURITY PHARMACEUTICALS, INC. v. BIONPHARMA INC. 1:2021cv01286 1 patentenalapril	D. Del.	2021-09-10	Terminated 2025-01-02	—
Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc. 1:2019cv01067 1 patentenalapril	D. Del.	2019-06-07	Terminated 2021-05-17	—

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

Medicare Part D Spending

CMS annual spending data for Vasotec (2023)

Total Spending

$3.4M

Total Claims

1,323

Beneficiaries

276

Avg Cost/Unit

$25.44

Spending Trend

$5.7M(2019)→$4.9M(2020)→$4.1M(2021)→$3.6M(2022)→$3.4M(2023)

YoY Change:+6.6%

5yr CAGR:+6.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs12 inactive

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

FARMHISPANIA SAENALAPRIL MALEATE

DMF 115251995

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDENALAPRIL MALEATE USP

DMF 143551999

NEULAND LABORATORIES LTDENALAPRIL MALEATE

DMF 154342001

NEULAND LABORATORIES LTDENALAPRIL MALEATE USP

DMF 199842006

SRI KRISHNA PHARMACEUTICALS LTDENALAPRIL MALEATE USP PROCESS-II

DMF 402112024

MERCK RESEARCH LABORATORIES DIV MERCK CO INCInactiveENALAPRIL MALEATE & DILTIAZEM ER TABLETS

DMF 111701994

MAPRIMED SAInactiveENALAPRIL MALEATE

DMF 116561995

ESTEVE QUIMICA SAInactiveENALAPRIL MALEATE

DMF 118661996

WOCKHARDT LTDInactiveENALAPRIL MALEATE

DMF 127801997

KRKA DD NOVO MESTOInactiveENALAPRIL MALEATE

DMF 128091997

GEDEON RICHTER LTDInactiveENALAPRIL MALEATE

DMF 129391998

MEDICHEM SAInactiveENALAPRIL MALEATE

DMF 130551998

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveENALAPRIL MALEATE USP

DMF 138201998

CHEMSOURCE CORPInactiveENALAPRIL MALEATE DRUG SUBSTANCE

DMF 149382000

PHARMACEUTICAL WORKS POLPHARMA SAInactiveENALAPRIL MALEATE

DMF 189502005

APOTEX PHARMACHEM INDIA PVT LTDInactiveENALAPRIL MALEATE USP

DMF 190582005

MAPRIMED SAInactiveENALAPRIL MALEATE

DMF 203172007

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Aug 27, 2015	SUPPL -80	View Letter (PDF)
Dec 30, 2014	SUPPL -79	View Letter (PDF)
Sep 17, 2012	SUPPL -77	View Letter (PDF)
Feb 23, 2012	SUPPL -76	View Letter (PDF)
Sep 29, 2008	SUPPL -71	View Letter (PDF)
Nov 8, 2007	SUPPL -70	View Letter (PDF)
Aug 30, 2002	SUPPL -63	View Letter (PDF)
Nov 27, 2001	SUPPL -58	View Letter (PDF)
Feb 13, 2001	SUPPL -59	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 24, 1985

No patent or exclusivity listings for this strength.

#002 — 10MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 24, 1985

#003 — 20MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 24, 1985

#005 — 2.5MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 26, 1988