Last Updated: June 25, 2026

NITRO Drug Patent Profile


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When do Nitro patents expire, and when can generic versions of Nitro launch?

Nitro is a drug marketed by Pohl Boskamp, Sanofi Aventis Us, Uspharma, Actavis Labs Fl Inc, Alembic, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Novel Labs Inc, Pom Pharma, Sun Pharm Industries, Watson Labs, Zydus Pharms, Actavis Mid Atlantic, Amneal Pharms, Annora Pharma, Aurobindo Pharma, Biocon Pharma, Novitium Pharma, Somerset Theraps Llc, Strides Pharma, Elkins Sinn, Ivax Sub Teva Pharms, Sandoz, Whiteworth Town Plsn, Alvogen, Chartwell Rx, Creekwood Pharms, Inventia, Omsav Pharma, Ranbaxy Labs Ltd, Sunny, Watson Labs Inc, Ambix, Lannett, Perrigo New York, Sun Pharma Canada, Wendt, Lannett Co Inc, Mylan Technologies, Abraxis Pharm, Am Regent, Hospira, Intl Medication, Luitpold, Smith And Nephew, Cosette, Encube, Solaris Pharma Corp, Tp Anda Holdings, Fougera Pharms Inc, Padagis Israel, Dr Reddys, Glenmark Speclt, Natco, Rubicon Research, Sigmapharm Labs Llc, Viwit Pharm, Baxter Hlthcare, Rorer, Evus, Abbott, Abbvie, Vpna, Parke Davis, and Viatris. and is included in one hundred and two NDAs. There is one patent protecting this drug.

The generic ingredient in NITRO is sodium nitroprusside. There are one thousand four hundred and seventy-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the sodium nitroprusside profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nitro

A generic version of NITRO was approved as sodium nitroprusside by SAGENT PHARMS INC on December 8th, 2016.

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Summary for NITRO

US Patents and Regulatory Information for NITRO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs NITROFURANTOIN MACROCRYSTALLINE nitrofurantoin, macrocrystalline CAPSULE;ORAL 070248-001 Jun 24, 1988 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Smith And Nephew NITROGLYCERIN nitroglycerin INJECTABLE;INJECTION 070633-001 Jun 19, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Amneal Pharms NITROFURANTOIN nitrofurantoin SUSPENSION;ORAL 201679-001 May 11, 2011 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sun Pharm Industries NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 201722-003 Feb 16, 2016 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Parke Davis NITROSTAT nitroglycerin INJECTABLE;INJECTION 018588-002 Dec 23, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.