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:	184
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
University of Alabama at Birmingham	Early Phase 1
Tanta University	N/A
University of Pavia	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
Parke Davis	NITROSTAT	nitroglycerin	INJECTABLE;INJECTION	018588-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pohl Boskamp	NITROLINGUAL	nitroglycerin	AEROSOL;SUBLINGUAL	018705-001	Oct 31, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	NITRO-BID	nitroglycerin	INJECTABLE;INJECTION	018621-001	Jan 5, 1982		DISCN	No	No	⤷ 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
Pohl Boskamp	NITRO IV	nitroglycerin	INJECTABLE;INJECTION	018672-002	Aug 30, 1983		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	RECTIV	nitroglycerin	OINTMENT;INTRA-ANAL	021359-001	Jun 21, 2011	AB	RX	Yes	Yes	⤷ 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
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	020144-004	Feb 27, 1996	⤷ Sign Up	⤷ Sign Up
Uspharma	NITRO-DUR	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020145-004	Apr 4, 1995	⤷ Sign Up	⤷ Sign Up
Novartis	TRANSDERM-NITRO	nitroglycerin	FILM, EXTENDED RELEASE;TRANSDERMAL	020144-005	Feb 27, 1996	⤷ 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	020144-004	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
Australia	2012219925	Packaging of solid pharmaceutical preparations containing the active substance glyceryl trinitrate	⤷ Sign Up
European Patent Office	2678000	GRANULES STABILISÉS CONTENANT DU TRINITRATE DE GLYCÉRYLE (STABILIZED GRANULES CONTAINING GLYCERYL TRINITRATE)	⤷ Sign Up
European Patent Office	2254552	PRÉPARATION PHARMACEUTIQUE À GRANDE STABILITÉ, CONTENANT LE PRINCIPE ACTIF TRINITRATE DE GLYCÉROL (LONG-TERM STABLE PHARMACEUTICAL PREPARATION HAVING THE ACTIVE INGREDIENT GLYCEROL TRINITRATE)	⤷ Sign Up
Poland	2678000		⤷ Sign Up
Germany	202008007318		⤷ Sign Up
Australia	2009224968	Long-term stable pharmaceutical preparation having the active ingredient glycerol trinitrate	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.