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Last Updated: July 2, 2020

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Aspirin - Generic Drug Details

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

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

Aspirin has thirty-seven patent family members in eighteen countries.

There are twenty-two drug master file entries for aspirin.

Drug Prices for aspirin

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Drug Sales Revenue Trends for aspirin

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Recent Clinical Trials for aspirin

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SponsorPhase
Centre Hospitalier Intercommunal CreteilPhase 3
Christian Torp-PedersenPhase 4
Aarhus University HospitalPhase 4

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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
Ingenus Pharms Nj CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE aspirin; carisoprodol; codeine phosphate TABLET;ORAL 040860-001 Jan 7, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Xanodyne Pharm DARVON COMPOUND aspirin; caffeine; propoxyphene hydrochloride CAPSULE;ORAL 010996-006 Mar 8, 1983 DISCN No No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim AGGRENOX aspirin; dipyridamole CAPSULE, EXTENDED RELEASE;ORAL 020884-001 Nov 22, 1999 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Ani Pharms Inc OXYCODONE AND ASPIRIN aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 040255-001 Feb 27, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Plx Pharma VAZALORE aspirin CAPSULE;ORAL 203697-001 Jan 14, 2013 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for aspirin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0984957 122012000017 Germany   Start 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   Start 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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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Express Scripts
McKesson
Boehringer Ingelheim
Dow

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