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-one 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:	31
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	188
Patent Applications:	6,098
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
Alexandria University	Phase 2/Phase 3
The First Affiliated Hospital with Nanjing Medical University	N/A
Huizhou Municipal Central Hospital	N/A

See all nitroglycerin clinical trials

Generic filers with tentative approvals for NITROGLYCERIN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	0.2MG/HR	Film, Extended Release; Transdermal
⤷ Sign Up	⤷ Sign Up	0.4MG/HR	Film, Extended Release; Transdermal
⤷ Sign Up	⤷ Sign Up	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
Abbvie	RECTIV	nitroglycerin	OINTMENT;INTRA-ANAL	021359-001	Jun 21, 2011	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-004	Apr 4, 1995		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Sa	NITROGLYCERIN	nitroglycerin	TABLET;SUBLINGUAL	206391-002	Sep 19, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Natco	NITROGLYCERIN	nitroglycerin	TABLET;SUBLINGUAL	211604-002	Apr 30, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Parke Davis	NITROSTAT	nitroglycerin	INJECTABLE;INJECTION	018588-002	Dec 23, 1983		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-005	Apr 4, 1995		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	NITRO-BID	nitroglycerin	INJECTABLE;INJECTION	071159-001	Feb 28, 1990		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Viatris	NITROSTAT	nitroglycerin	TABLET;SUBLINGUAL	021134-002	May 1, 2000	⤷ Sign Up	⤷ Sign Up
Viatris	NITROSTAT	nitroglycerin	TABLET;SUBLINGUAL	021134-003	May 1, 2000	⤷ Sign Up	⤷ Sign Up
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-005	Apr 4, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-002	Feb 27, 1996	⤷ Sign Up	⤷ Sign Up
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-005	Feb 27, 1996	⤷ Sign Up	⤷ Sign Up
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-005	Feb 27, 1996	⤷ Sign Up	⤷ Sign Up
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-002	Feb 27, 1996	⤷ Sign Up	⤷ Sign Up
>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
World Intellectual Property Organization (WIPO)	2009112258		⤷ Sign Up
Australia	2012219925	Packaging of solid pharmaceutical preparations containing the active substance glyceryl trinitrate	⤷ Sign Up
Spain	2565632		⤷ Sign Up
Spain	2672261		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2012113563		⤷ Sign Up
Poland	2678000		⤷ Sign Up
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)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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