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Last Updated: April 19, 2024

Nitroglycerin - Generic Drug Details

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What are the generic sources for nitroglycerin and what is the scope of freedom to operate?

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
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-005	Apr 4, 1995		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	TRIDIL	nitroglycerin	INJECTABLE;INJECTION	018537-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	NITROGLYCERIN	nitroglycerin	TABLET;SUBLINGUAL	210153-002	Mar 8, 2022		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	NITROGLYCERIN	nitroglycerin	INJECTABLE;INJECTION	018531-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pohl Boskamp	GONITRO	nitroglycerin	POWDER;SUBLINGUAL	208424-001	Jun 8, 2016		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-004	Feb 27, 1996		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	NITROGLYCERIN	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	089885-002	Oct 30, 2017	AB2	RX	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
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-002	Apr 4, 1995	⤷ Try a Trial	⤷ Try a Trial
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-003	Apr 4, 1995	⤷ Try a Trial	⤷ Try a Trial
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-004	Feb 27, 1996	⤷ Try a Trial	⤷ Try a Trial
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-004	Apr 4, 1995	⤷ Try a Trial	⤷ Try a Trial
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-004	Feb 27, 1996	⤷ Try a Trial	⤷ Try a Trial
Evus	NITROMIST	nitroglycerin	AEROSOL, METERED;SUBLINGUAL	021780-001	Nov 2, 2006	⤷ Try a Trial	⤷ Try a Trial
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-002	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
Australia	2012219925	Packaging of solid pharmaceutical preparations containing the active substance glyceryl trinitrate	⤷ Try a Trial
Spain	2565632		⤷ Try a Trial
European Patent Office	3354259	GRANULES STABILISÉES CONTENANT DU TRINITRATE DE GLYCÉRYL (STABILIZED GRANULES CONTAINING GLYCERYL TRINITRATE)	⤷ Try a Trial
Spain	2672261		⤷ Try a Trial
Poland	2678006		⤷ Try a Trial
Australia	2009224968	Long-term stable pharmaceutical preparation having the active ingredient glycerol trinitrate	⤷ Try a Trial
Brazil	PI0908577	preparação farmacêutica estável por longo tempo com a substância ativa trinitrato de glicerol	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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