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EPANED KIT

NDA

ENALAPRIL MALEATE | N204308 | AZURITY PHARMACEUTICALS INC

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

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2033

Today

Nov. 6, 2032

Nov. 6, 2032

Nov. 6, 2032

Nov. 6, 2032

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
Silvergate Pharmaceuticals, Inc. v. Bionpharma, Inc. 1:2017cv00016	D. Del.	2017-01-05	Terminated 2018-10-09	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

103 trials from ClinicalTrials.gov — 4 recruiting, 65 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Angiotensin Converting Enzyme Inhibitors in Treatment of Covid 19 NCT04345406	Phase 3	Not Yet Recruiting	Tanta University	60	2020-04-15 → 2029-12-01
NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients NCT02817360	Phase 4	Recruiting	Martin Huelsmann	2,400	2016-02 → 2026-12
Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy NCT04183101	Phase 2	Recruiting	Region Skane	30	2020-10-01 → 2029-12
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
The Relationship Between HHcy and Contrast-induced Nephropathy in Hypertensive Patients After Coronary Artery Diagnosis and Treatment NCT02575092	Phase 2/3	Completed	Fuling Central Hospital of Chongqing City	4,000	2015-11-01 → 2019-07-31
Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.NCT03667131	Phase 2	Completed	University of Guadalajara	59	2017-02-13 → 2018-02-19
Study on the Effects of Sacubitril/Valsartan on Physical Activity and Sleep in Heart Failure With Reduced Ejection Fraction Patients.NCT02970669	Phase 4	Completed	Novartis Pharmaceuticals	140	2016-12-16 → 2018-03-19
Exercise Capacity Study of LCZ696 vs. Enalapril in Patients With Chronic Heart Failure and Reduced Ejection Fraction.NCT02768298	Phase 4	Completed	Novartis Pharmaceuticals	201	2016-07-12 → 2019-11-25
Studies of Left Ventricular Dysfunction (SOLVD)NCT00000516	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1985-07 → 1990-05
Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype NCT02135263	Phase 4	Completed	Bispebjerg Hospital	44	2012-04 → 2014-05

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

API Supply Chain7 active DMFs13 inactive

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

FARMHISPANIA SAENALAPRIL MALEATE

DMF 115251995

DR REDDYS LABORATORIES LTDENALAPRIL MALEATE, USP

DMF 138361998

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

NEULAND LABORATORIES LTDENALAPRIL MALEATE USP (PROCESS-II)

DMF 436182026

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

LEK PHARMACEUTICALS DDInactiveENALAPRIL MALEATE, ACTIVE SUBSTANCE

DMF 131141998

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

6 letters from Drugs@FDA

Date	Submission	Document
Aug 2, 2017	SUPPL -7	View Letter (PDF)
Mar 24, 2017	SUPPL -6	View Letter (PDF)
Jan 29, 2016	SUPPL -5	View Letter (PDF)
Sep 8, 2014	SUPPL -2	View Letter (PDF)
Sep 8, 2014	SUPPL -3	View Letter (PDF)
Aug 15, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

4 patents0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Aug 13, 2013

Patents (4) · 10 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8568747	Nov 6, 2032	—	—	Yes	—	—
8778366	Nov 6, 2032	—	—	—		—
9855214	Nov 6, 2032	—	—	Yes	—	—
9968553	Nov 6, 2032	—	—	—		—