NITROSTAT Drug Patent Profile
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Which patents cover Nitrostat, and what generic alternatives are available?
Nitrostat is a drug marketed by Parke Davis and Viatris and is included in five NDAs.
The generic ingredient in NITROSTAT is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nitrostat
A generic version of NITROSTAT was approved as nitroglycerin by AM REGENT on May 24th, 1988.
Summary for NITROSTAT
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 5 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 36 |
Clinical Trials: | 4 |
Patent Applications: | 3,113 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for NITROSTAT |
What excipients (inactive ingredients) are in NITROSTAT? | NITROSTAT excipients list |
DailyMed Link: | NITROSTAT at DailyMed |
Recent Clinical Trials for NITROSTAT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Futura Medical Developments Ltd. | Phase 1 |
Montefiore Medical Center | N/A |
Mayo Clinic | N/A |
Pharmacology for NITROSTAT
Drug Class | Nitrate Vasodilator |
Physiological Effect | Vasodilation |
Paragraph IV (Patent) Challenges for NITROSTAT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
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 NITROSTAT
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-002 | May 1, 2000 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Parke Davis | NITROSTAT | nitroglycerin | INJECTABLE;INJECTION | 070871-001 | Jan 8, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-003 | May 1, 2000 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Parke Davis | NITROSTAT | nitroglycerin | INJECTABLE;INJECTION | 070863-001 | Jan 8, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Parke Davis | NITROSTAT | nitroglycerin | INJECTABLE;INJECTION | 018588-002 | Dec 23, 1983 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-001 | May 1, 2000 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 NITROSTAT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-003 | May 1, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-001 | May 1, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-002 | May 1, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NITROSTAT
See the table below for patents covering NITROSTAT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | 209911 | ⤷ Try a Trial | |
Portugal | 1019039 | ⤷ Try a Trial | |
Israel | 134395 | COMPRESSED NITROGYLYCERIN TABLET AND ITS METHOD OF MANUFACTURE | ⤷ Try a Trial |
South Korea | 20010030839 | ⤷ Try a Trial | |
Canada | 2299231 | TABLETTE COMPRIMEE DE NITROGLYCERINE ET SON PROCEDE DE FABRICATION (COMPRESSED NITROGLYCERIN TABLET AND ITS METHOD OF MANUFACTURE) | ⤷ Try a Trial |
Japan | 2001518500 | ⤷ Try a Trial | |
South Korea | 100569763 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |