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 Speclt, 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-three 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: | 33 |
Raw Ingredient (Bulk) Api Vendors: | 36 |
Clinical Trials: | 188 |
Patent Applications: | 6,364 |
Drug Prices: | Drug price trends for NITROGLYCERIN |
What excipients (inactive ingredients) are in NITROGLYCERIN? | NITROGLYCERIN excipients list |
DailyMed Link: | NITROGLYCERIN at DailyMed |
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 |
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
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rubicon | NITROGLYCERIN | nitroglycerin | TABLET;SUBLINGUAL | 209779-002 | May 3, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sigmapharm Labs Llc | NITROGLYCERIN | nitroglycerin | TABLET;SUBLINGUAL | 207745-003 | May 7, 2018 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Mankind Pharma | NITROGLYCERIN | nitroglycerin | TABLET;SUBLINGUAL | 217970-001 | Dec 5, 2023 | AB | RX | 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 | ||||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | TRANSDERM-NITRO | nitroglycerin | FILM, EXTENDED RELEASE;TRANSDERMAL | 020144-003 | Feb 27, 1996 | ⤷ 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 | 020144-002 | Feb 27, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Evus | NITROMIST | nitroglycerin | AEROSOL, METERED;SUBLINGUAL | 021780-001 | Nov 2, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NITROGLYCERIN
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2012219925 | Packaging of solid pharmaceutical preparations containing the active substance glyceryl trinitrate | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2012113564 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2012113563 | ⤷ Sign Up | |
European Patent Office | 2678000 | GRANULES STABILISÉS CONTENANT DU TRINITRATE DE GLYCÉRYLE (STABILIZED GRANULES CONTAINING GLYCERYL TRINITRATE) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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