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Generated: June 25, 2017

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 Abraxis Pharm, Pohl Boskamp, Kremers Urban Pharms, Sanofi Aventis Us, Intl Medication, Hospira, Smith And Nephew, Luitpold, Pfizer Pharms, Novartis, Merck Sharp Dohme, 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, and Perrigo Israel, and is included in forty-two NDAs. There are four patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nitroglycerin has twenty-nine patent family members in sixteen countries.

There are thirty-six drug master file entries for nitroglycerin. Thirty-nine suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: nitroglycerin

Tradenames:16
Patents:4
Applicants:24
NDAs:42
Drug Master File Entries: see list36
Suppliers / Packagers: see list39
Bulk Api Vendors: see list16
Clinical Trials: see list117
Patent Applications: see list4,086
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:nitroglycerin at DailyMed

Pharmacology for Ingredient: nitroglycerin

Ingredient-typeNitrates
Drug ClassNitrate Vasodilator
Physiological EffectVasodilation

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
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Technologies
NITROGLYCERIN
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL074992-004Nov 12, 1999DISCNNoNo► Subscribe► Subscribe
Pohl Boskamp
NITRONAL
nitroglycerin
INJECTABLE;INJECTION018672-001Aug 30, 1983DISCNNoNo► Subscribe► Subscribe
Hospira
TRIDIL
nitroglycerin
INJECTABLE;INJECTION018537-002Jun 16, 1983DISCNNoNo► Subscribe► Subscribe
Baxter Hlthcare
NITROGLYCERIN IN DEXTROSE 5%
nitroglycerin
INJECTABLE;INJECTION019970-001Dec 29, 1989APRXYesYes► Subscribe► Subscribe
Novartis
TRANSDERM-NITRO
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020144-001Feb 27, 1996DISCNYesNo► 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;TRANSDERMAL020144-001Feb 27, 19964,954,344► Subscribe
Merck Sharp Dohme
NITRO-DUR
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020145-005Apr 4, 19955,186,938► Subscribe
Merck Sharp Dohme
NITRO-DUR
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020145-004Apr 4, 19955,186,938► Subscribe
Merck Sharp Dohme
NITRO-DUR
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020145-006Apr 4, 19955,186,938► Subscribe
Novartis
TRANSDERM-NITRO
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020144-005Feb 27, 19964,812,313► 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
Australia759018► Subscribe
Austria209911► Subscribe
Israel208151► Subscribe
Germany202008007318► Subscribe
Germany69802832► 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 500+ biopharmaceutical companies globally:

Fuji
Teva
McKesson
Accenture
Covington
Citi
Julphar
McKinsey
Federal Trade Commission
Chinese Patent Office

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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ISSN: 2162-2639

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