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Last Updated: November 21, 2024

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 Speclt, 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.

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Summary for NITROGLYCERIN
Drug patent expirations by year for NITROGLYCERIN
Drug Prices for NITROGLYCERIN

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Drug Sales Revenue Trends for NITROGLYCERIN

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Recent Clinical Trials for NITROGLYCERIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alexandria UniversityPhase 2/Phase 3
The First Affiliated Hospital with Nanjing Medical UniversityN/A
Huizhou Municipal Central HospitalN/A

See all NITROGLYCERIN clinical trials

Pharmacology for NITROGLYCERIN
Drug ClassNitrate Vasodilator
Physiological EffectVasodilation
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: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 208191-001 Aug 26, 2016 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
Rubicon NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 209779-002 May 3, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 210153-001 Mar 8, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Baxter Hlthcare NITROGLYCERIN IN DEXTROSE 5% nitroglycerin INJECTABLE;INJECTION 019970-003 Dec 29, 1989 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

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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.