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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
AstraZeneca
Teva
Chubb
Julphar
Argus Health
Express Scripts
US Department of Justice
Cantor Fitzgerald

Generated: January 16, 2018

DrugPatentWatch Database Preview

Nitroglycerin - Generic Drug Details

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

Nitroglycerin
is the generic ingredient in sixteen branded drugs marketed by Mist Pharms Llc, Pohl Boskamp, Medicis, Valeant Pharms, Valeant Pharms North, Uspharma, Hercon Pharm, Kremers Urban Pharms, Mylan Technologies, Novartis, Sanofi Aventis Us, Abraxis Pharm, Hospira, Intl Medication, Luitpold, Smith And Nephew, Baxter Hlthcare, Rorer, Parke Davis, Forest Labs Inc, Fougera Pharms Inc, Perrigo Israel, Actavis Labs Fl Inc, Dr Reddys Labs Inc, Glenmark Pharms Ltd, and Pfizer Pharms, and is included in forty-four NDAs. There are three patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nitroglycerin has thirty-five patent family members in seventeen countries.

There are thirty-six drug master file entries for nitroglycerin. Forty-one suppliers are listed for this compound. There are three tentative approvals for this compound.
Pharmacology for nitroglycerin
Ingredient-typeNitrates
Drug ClassNitrate Vasodilator
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for nitroglycerin
Tentative approvals for NITROGLYCERIN
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe0.2MG/HRFilm, Extended Release; Transdermal
➤ Subscribe➤ Subscribe0.4MG/HRFilm, Extended Release; Transdermal
➤ Subscribe➤ Subscribe0.6MG/HRFilm, Extended Release; Transdermal

US Patents and Regulatory Information for nitroglycerin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pohl Boskamp NITROLINGUAL PUMPSPRAY nitroglycerin SPRAY, METERED;SUBLINGUAL 018705-002 Jan 10, 1997 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Dr Reddys Labs Inc NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 208191-002 Aug 26, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-001 Apr 4, 1995 AB1 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Kremers Urban Pharms NITROGLYCERIN nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 075115-001 Aug 10, 2004 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer Pharms NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-003 May 1, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Parke Davis NITROSTAT nitroglycerin INJECTABLE;INJECTION 070863-001 Jan 8, 1987 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-003 Apr 4, 1995 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pohl Boskamp NITRONAL nitroglycerin INJECTABLE;INJECTION 018672-001 Aug 30, 1983 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Luitpold NITROGLYCERIN nitroglycerin INJECTABLE;INJECTION 071492-001 May 24, 1988 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer Pharms NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-001 May 1, 2000 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for nitroglycerin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-004 Apr 4, 1995 ➤ Subscribe ➤ Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-002 Feb 27, 1996 ➤ Subscribe ➤ Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-004 Feb 27, 1996 ➤ Subscribe ➤ Subscribe
Mist Pharms Llc NITROMIST nitroglycerin AEROSOL, METERED;SUBLINGUAL 021780-001 Nov 2, 2006 ➤ Subscribe ➤ Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-005 Feb 27, 1996 ➤ Subscribe ➤ Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-004 Feb 27, 1996 ➤ Subscribe ➤ Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-001 Feb 27, 1996 ➤ Subscribe ➤ Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-003 Feb 27, 1996 ➤ Subscribe ➤ Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-003 Feb 27, 1996 ➤ Subscribe ➤ Subscribe
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-002 Feb 27, 1996 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for nitroglycerin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,616,023 Stabilized granules containing glyceryl trinitrate ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for nitroglycerin

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Serving leading biopharmaceutical companies globally:

Novartis
Mallinckrodt
QuintilesIMS
Moodys
Express Scripts
McKesson
Johnson and Johnson
Farmers Insurance
Harvard Business School

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 verifification 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.

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