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Last Updated: May 21, 2024

Aspirin - Generic Drug Details


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What are the generic sources for aspirin and what is the scope of patent protection?

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
Catharina Ziekenhuis EindhovenPhase 2
Radboud University Medical CenterPhase 2
Haaglanden Medical CentrePhase 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
Oxford Pharms CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE aspirin; carisoprodol; codeine phosphate TABLET;ORAL 040283-001 Dec 29, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane OXYCODONE AND ASPIRIN (HALF-STRENGTH) aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 087742-001 Jun 4, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Industries OXYCODONE AND ASPIRIN aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 040260-001 Jul 17, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb PRAVIGARD PAC (COPACKAGED) aspirin; pravastatin sodium TABLET;ORAL 021387-003 Jun 24, 2003 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
Japan 2017222650 胃腸管に沿った医薬の標的化放出のためのpH依存性担体、それによる組成物、ならびにこれらの製造および使用 (PH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME) ⤷  Try a Trial
China 103957888 Ph dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same ⤷  Try a Trial
Japan 6368645 ⤷  Try a Trial
South Korea 102188840 ⤷  Try a Trial
Japan 6799504 ⤷  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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.