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Last Updated: April 25, 2024

Nitroglycerin - Generic Drug Details

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What are the generic drug sources for nitroglycerin and what is the scope of patent protection?

Nitroglycerin is the generic ingredient in sixteen branded drugs marketed by Evus, Pohl Boskamp, Bausch, Valeant Pharms, Valeant Pharms North, Uspharma, Lannett Co Inc, Mylan Technologies, Zydus Pharms, Novartis, Sanofi Aventis Us, Abraxis Pharm, Am Regent, Hospira, Intl Medication, Luitpold, Smith And Nephew, Baxter Hlthcare, Rorer, Parke Davis, Cosette, Abbvie, Fougera Pharms Inc, Padagis Israel, Actavis Labs Fl Inc, Aurobindo Pharma, Dr Reddys, Glenmark Pharms Sa, Mankind Pharma, Natco, Rubicon, Sigmapharm Labs Llc, and Viatris, and is included in fifty-one NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nitroglycerin has twenty patent family members in nine countries.

There are thirty-six drug master file entries for nitroglycerin. Thirty-three suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for nitroglycerin

International Patents:	20
US Patents:	2
Tradenames:	16
Applicants:	33
NDAs:	51
Drug Master File Entries:	36
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	184
Patent Applications:	6,357
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for nitroglycerin
What excipients (inactive ingredients) are in nitroglycerin?	nitroglycerin excipients list
DailyMed Link:	nitroglycerin at DailyMed

See drug prices for nitroglycerin

Drug Sales Revenue Trends for nitroglycerin

See drug sales revenues for nitroglycerin

Recent Clinical Trials for nitroglycerin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Alabama at Birmingham	Early Phase 1
Tanta University	N/A
Pak Emirates Military Hospital	N/A

See all nitroglycerin clinical trials

Generic filers with tentative approvals for NITROGLYCERIN

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	0.2MG/HR	Film, Extended Release; Transdermal
⤷ Try a Trial	⤷ Try a Trial	0.4MG/HR	Film, Extended Release; Transdermal
⤷ Try a Trial	⤷ Try a Trial	0.6MG/HR	Film, Extended Release; Transdermal

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for nitroglycerin

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for nitroglycerin

Explosive Agents
Vasodilator Agents

Paragraph IV (Patent) Challenges for NITROGLYCERIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NITROLINGUAL PUMPSPRAY	Sublingual Spray	nitroglycerin	400 mcg/spray, 4.9 g and 12 g bottles	018705	1	2012-04-17
NITROSTAT	Sublingual Tablets	nitroglycerin	0.3 mg, 0.4 mg, and 0.6 mg	021134	1	2005-10-19

US Patents and Regulatory Information for nitroglycerin

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	NITROGLYCERIN IN DEXTROSE 5%	nitroglycerin	INJECTABLE;INJECTION	019970-003	Dec 29, 1989		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Technologies	NITROGLYCERIN	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	074992-001	Nov 12, 1999		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Technologies	NITROGLYCERIN	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	074992-003	Nov 12, 1999		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sigmapharm Labs Llc	NITROGLYCERIN	nitroglycerin	TABLET;SUBLINGUAL	207745-003	May 7, 2018		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lannett Co Inc	NITROGLYCERIN	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	075115-001	Aug 10, 2004		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Parke Davis	NITROSTAT	nitroglycerin	INJECTABLE;INJECTION	070871-001	Jan 8, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	NITROGLYCERIN	nitroglycerin	TABLET;SUBLINGUAL	210153-003	Mar 8, 2022		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for nitroglycerin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	RECTIV	nitroglycerin	OINTMENT;INTRA-ANAL	021359-001	Jun 21, 2011	⤷ Try a Trial	⤷ Try a Trial
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-005	Feb 27, 1996	⤷ Try a Trial	⤷ Try a Trial
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-001	Feb 27, 1996	⤷ Try a Trial	⤷ Try a Trial
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-006	Apr 4, 1995	⤷ Try a Trial	⤷ Try a Trial
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-002	Apr 4, 1995	⤷ Try a Trial	⤷ Try a Trial
Pohl Boskamp	NITROLINGUAL PUMPSPRAY	nitroglycerin	SPRAY, METERED;SUBLINGUAL	018705-002	Jan 10, 1997	⤷ Try a Trial	⤷ Try a Trial
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-003	Feb 27, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for nitroglycerin

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3354259	GRANULES STABILISÉES CONTENANT DU TRINITRATE DE GLYCÉRYL (STABILIZED GRANULES CONTAINING GLYCERYL TRINITRATE)	⤷ Try a Trial
European Patent Office	2678000	GRANULES STABILISÉS CONTENANT DU TRINITRATE DE GLYCÉRYLE (STABILIZED GRANULES CONTAINING GLYCERYL TRINITRATE)	⤷ Try a Trial
Australia	2012219926	Stabilized granules containing glyceryl trinitrate	⤷ Try a Trial
Canada	2718345	PREPARATION PHARMACEUTIQUE A GRANDE STABILITE, CONTENANT LE PRINCIPE ACTIF TRINITRATE DE GLYCEROL (LONG-TERM STABLE PHARMACEUTICAL PREPARATION HAVING THE ACTIVE INGREDIENT GLYCEROL TRINITRATE)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2012113564		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2009112258		⤷ Try a Trial
Germany	202008007318		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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