NITROGLYCERIN Drug Patent Profile
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Which patents cover Nitroglycerin, and what generic alternatives are available?
Nitroglycerin is a drug marketed by Lannett Co Inc, Mylan Technologies, Zydus Pharms, Abraxis Pharm, Am Regent, Hospira, Intl Medication, Luitpold, Smith And Nephew, Cosette, Fougera Pharms Inc, Padagis Israel, Actavis Labs Fl Inc, Aurobindo Pharma, Dr Reddys, Glenmark Pharms Sa, Mankind Pharma, Natco, Rubicon, Sigmapharm Labs Llc, and Baxter Hlthcare. and is included in thirty-one NDAs.
The generic ingredient in NITROGLYCERIN 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 Nitroglycerin
A generic version of NITROGLYCERIN was approved as nitroglycerin by AM REGENT on May 24th, 1988.
Summary for NITROGLYCERIN
| US Patents: | 0 |
| Applicants: | 21 |
| NDAs: | 31 |
| Finished Product Suppliers / Packagers: | 24 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 184 |
| Patent Applications: | 3,109 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NITROGLYCERIN |
| What excipients (inactive ingredients) are in NITROGLYCERIN? | NITROGLYCERIN excipients list |
| DailyMed Link: | NITROGLYCERIN at DailyMed |
See drug prices for NITROGLYCERIN
Recent Clinical Trials for NITROGLYCERIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alabama at Birmingham | Early Phase 1 |
| Tanta University | N/A |
| Pak Emirates Military Hospital | N/A |
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
NITROGLYCERIN is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting NITROGLYCERIN
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Natco | NITROGLYCERIN | nitroglycerin | TABLET;SUBLINGUAL | 211604-001 | Apr 30, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Dr Reddys | NITROGLYCERIN | nitroglycerin | TABLET;SUBLINGUAL | 208191-001 | Aug 26, 2016 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sigmapharm Labs Llc | NITROGLYCERIN | nitroglycerin | TABLET;SUBLINGUAL | 207745-003 | May 7, 2018 | DISCN | No | 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 |
