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.
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Summary for NITROSTAT
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 4 |
| Patent Applications: | 3,059 |
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-002 | May 1, 2000 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Parke Davis | NITROSTAT | nitroglycerin | INJECTABLE;INJECTION | 070871-001 | Jan 8, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-003 | May 1, 2000 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Parke Davis | NITROSTAT | nitroglycerin | INJECTABLE;INJECTION | 070863-001 | Jan 8, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Parke Davis | NITROSTAT | nitroglycerin | INJECTABLE;INJECTION | 018588-002 | Dec 23, 1983 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-001 | May 1, 2000 | AB | RX | Yes | No | ⤷ 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 NITROSTAT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-001 | May 1, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-003 | May 1, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Viatris | NITROSTAT | nitroglycerin | TABLET;SUBLINGUAL | 021134-002 | May 1, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| South Korea | 100569763 | ⤷ Sign Up | |
| Canada | 2299231 | TABLETTE COMPRIMEE DE NITROGLYCERINE ET SON PROCEDE DE FABRICATION (COMPRESSED NITROGLYCERIN TABLET AND ITS METHOD OF MANUFACTURE) | ⤷ Sign Up |
| Australia | 759018 | ⤷ Sign Up | |
| Japan | 2001518500 | ⤷ Sign Up | |
| Australia | 9489398 | ⤷ Sign Up | |
| Denmark | 1019039 | ⤷ Sign Up | |
| Slovenia | 1019039 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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 verification 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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