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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
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Generated: November 19, 2017

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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 Abraxis Pharm, Pohl Boskamp, Kremers Urban Pharms, Sanofi Aventis Us, Intl Medication, Hospira, Smith And Nephew, Luitpold, Pfizer Pharms, Novartis, Uspharma, Fougera Pharms Inc, Mylan Technologies, Forest Labs Inc, Parke Davis, Baxter Hlthcare, Valeant Pharms, Valeant Pharms North, Medicis, Rorer, Mist Pharms Llc, Hercon Pharm, Dr Reddys Labs Inc, Glenmark Pharms Ltd, and Perrigo Israel, and is included in forty-three 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-three patent family members in sixteen 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
u► Subscribe0.2MG/HRFilm, Extended Release; Transdermal
u► Subscribe0.4MG/HRFilm, Extended Release; Transdermal
u► Subscribe0.6MG/HRFilm, Extended Release; Transdermal
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rorer
NITROL
nitroglycerin
INJECTABLE;INJECTION018774-001Jan 19, 1983DISCNNoNo► Subscribe► Subscribe► Subscribe
Novartis
TRANSDERM-NITRO
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020144-004Feb 27, 1996DISCNYesNo► Subscribe► Subscribe► Subscribe
Glenmark Pharms Ltd
NITROGLYCERIN
nitroglycerin
TABLET;SUBLINGUAL206391-003Sep 19, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Abraxis Pharm
NITROGLYCERIN
nitroglycerin
INJECTABLE;INJECTION070077-001Dec 13, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe
Smith And Nephew
NITROGLYCERIN
nitroglycerin
INJECTABLE;INJECTION070634-001Jun 19, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Kremers Urban Pharms
NITROGLYCERIN
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL075115-001Aug 10, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Baxter Hlthcare
NITROGLYCERIN IN DEXTROSE 5%
nitroglycerin
INJECTABLE;INJECTION019970-003Dec 29, 1989APRXYesYes► Subscribe► Subscribe► Subscribe
Valeant Pharms
MINITRAN
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL089771-001Aug 30, 1996AB1RXNoNo► Subscribe► Subscribe► Subscribe
Baxter Hlthcare
NITROGLYCERIN IN DEXTROSE 5%
nitroglycerin
INJECTABLE;INJECTION019970-002Dec 29, 1989APRXYesYes► Subscribe► Subscribe► Subscribe
Novartis
TRANSDERM-NITRO
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020144-001Feb 27, 1996DISCNYesNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nitroglycerin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
TRANSDERM-NITRO
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020144-002Feb 27, 1996► Subscribe► Subscribe
Forest Labs Inc
RECTIV
nitroglycerin
OINTMENT;INTRA-ANAL021359-001Jun 21, 2011► Subscribe► Subscribe
Uspharma
NITRO-DUR
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020145-002Apr 4, 1995► Subscribe► Subscribe
Pohl Boskamp
NITROLINGUAL PUMPSPRAY
nitroglycerin
SPRAY, METERED;SUBLINGUAL018705-002Jan 10, 1997► Subscribe► Subscribe
Uspharma
NITRO-DUR
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020145-006Apr 4, 1995► Subscribe► Subscribe
Novartis
TRANSDERM-NITRO
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020144-001Feb 27, 1996► Subscribe► Subscribe
Novartis
TRANSDERM-NITRO
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020144-005Feb 27, 1996► Subscribe► Subscribe
Novartis
TRANSDERM-NITRO
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020144-003Feb 27, 1996► Subscribe► Subscribe
Mist Pharms Llc
NITROMIST
nitroglycerin
AEROSOL, METERED;SUBLINGUAL021780-001Nov 2, 2006► Subscribe► Subscribe
Uspharma
NITRO-DUR
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020145-004Apr 4, 1995► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,616,023Stabilized granules containing glyceryl trinitrate► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: nitroglycerin

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9917766► Subscribe
Brazil9812605► Subscribe
Spain2565632► Subscribe
World Intellectual Property Organization (WIPO)2012113563► Subscribe
Portugal1019039► Subscribe
BrazilPI0908577► Subscribe
Slovenia1019039► Subscribe
Germany202008007318► Subscribe
Australia2012219926► Subscribe
Japan2001518500► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Cerilliant
Julphar
Citi
Covington
Chinese Patent Office
Argus Health
Farmers Insurance
Fuji
Fish and Richardson
Chubb

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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