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ENALAPRIL MALEATE

ANDA

ENALAPRIL MALEATE | A212408 | BIONPHARMA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: EPANED(TE code: AB)

Hatch-Waxman Litigation

4 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
AZURITY PHARMACEUTICALS, INC. v. NOVITIUM PHARMA, LLC 1:2023cv00163 2 patentsANDA 212408enalapril maleate	D. Del.	2023-02-14	Terminated 2024-04-08	—
AZURITY PHARMACEUTICALS, INC. v. NOVITIUM PHARMA, LLC 2:2022cv05860 2 patentsANDA 212408enalapril maleate	D.N.J.	2022-10-03	Terminated 2023-01-23	—
Azurity Pharmaceuticals, Inc. v. Bionpharma Inc. 1:2021cv01455 2 patentsANDA 212408enalapril maleate	D. Del.	2021-10-15	Terminated 2025-01-02	—
Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc. 1:2018cv01962 3 patentsANDA 212408enalapril maleate	D. Del.	2018-12-12	Terminated 2021-05-17	—

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Sep 2, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Aug 10, 2021

No patent or exclusivity listings for this strength.