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Last Updated: March 28, 2024

Aspirin - Generic Drug Details


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What are the generic drug sources for aspirin and what is the scope of freedom to operate?

Aspirin is the generic ingredient in fifty-three branded drugs marketed by Hesp, Plx Pharma, Bayer, Savage Labs, Lgm Pharma, Nostrum Labs Inc, Watson Labs, Allergan, Sandoz, Actavis Elizabeth, Fosun Pharma, Halsey, Hikma Intl Pharms, Ivax Pharms, Puracap Pharm, Quantum Pharmics, Strides Pharma, Lannett, Dr Reddys Labs Sa, Stevens J, Sun Pharm Industries, Bausch, Galt Pharms, Alra, Xanodyne Pharm, Ivax Sub Teva Pharms, Teva, Chartwell Rx, Novast Labs, Oxford Pharms, Meda Pharms, Ingenus Pharms Nj, Boehringer Ingelheim, Amneal Pharms, Ani Pharms, Barr, Chartwell Molecular, Dr Reddys, Glenmark Pharms Sa, Micro Labs, Par Pharm Inc, Sun Pharm, Zydus Pharms, Schwarz Pharma, Abbott, Par Pharm, Medpointe Pharm Hlc, Mcneil, Robins Ah, Genus Lifesciences, Actavis Labs Fl Inc, Epic Pharma Llc, Endo Pharms, Roxane, Sanofi Aventis Us, Bristol Myers Squibb, and Aaipharma Llc, and is included in eighty-nine NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aspirin has twenty patent family members in nine countries.

There are twenty-two drug master file entries for aspirin. One supplier is listed for this compound. There is one tentative approval for this compound.

Drug Prices for aspirin

See drug prices for aspirin

Drug Sales Revenue Trends for aspirin

See drug sales revenues for aspirin

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for aspirin
Generic Entry Date for aspirin*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for aspirin

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

SponsorPhase
Amphia HospitalPhase 2
Maastricht University Medical CenterPhase 2
Erasmus Medical CenterPhase 2

See all aspirin clinical trials

Generic filers with tentative approvals for ASPIRIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial325MG;40MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial81MG;40MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for aspirin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Sa OXYCODONE AND ASPIRIN aspirin; oxycodone hydrochloride TABLET;ORAL 091670-001 Mar 16, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Sa BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE aspirin; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 203335-001 Oct 30, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm MEPROBAMATE AND ASPIRIN aspirin; meprobamate TABLET;ORAL 089126-001 Aug 19, 1986 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

Expired US Patents for aspirin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Plx Pharma VAZALORE aspirin CAPSULE;ORAL 203697-001 Jan 14, 2013 ⤷  Try a Trial ⤷  Try a Trial
Plx Pharma VAZALORE aspirin CAPSULE;ORAL 203697-001 Jan 14, 2013 ⤷  Try a Trial ⤷  Try a Trial
Plx Pharma VAZALORE aspirin CAPSULE;ORAL 203697-001 Jan 14, 2013 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for aspirin

Country Patent Number Title Estimated Expiration
South Korea 20200008032 위장관을 따라 약물을 표적화 방출하기 위한 pH 감응성 담체, 그로부터의 조성물, 및 이들의 제조 및 사용 방법 (pH PH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT COMPOSITIONS THEREFROM AND MAKING AND USING SAME) ⤷  Try a Trial
Mexico 340951 PORTADORES DEPENDIENTES DEL PH PARA LA LIBERACION DIRIGIDA DE PRODUCTOS FARMACEUTICOS A LO LARGO DEL TRACTO GASTROINTESTINAL, COMPOSICIONES DE LOS MISMOS, Y FABRICACIÓN Y USO DE LAS MISMAS. (pH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME.) ⤷  Try a Trial
South Korea 20200118219 위장관을 따라 약물을 표적화 방출하기 위한 pH 감응성 담체, 그로부터의 조성물, 및 이들의 제조 및 사용 방법 (pH PH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT COMPOSITIONS THEREFROM AND MAKING AND USING SAME) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for aspirin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0984957 122012000017 Germany ⤷  Try a Trial PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
0984957 2012/048 Ireland ⤷  Try a Trial PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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