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Last Updated: April 17, 2021

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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, Lgm Pharma, Mayne 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, Epic Pharma Llc, Endo Pharms, Roxane, Sanofi Aventis Us, Bristol Myers Squibb, and Aaipharma Llc, and is included in eighty-six NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aspirin has forty-two 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

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

SponsorPhase
First Affiliated Hospital of Zhejiang UniversityN/A
Ningbo No.2 HospitalN/A
TAIZHOU HOSPITAL OF ZHEJIANG PROVINCEN/A

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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
Meda Pharms SOMA COMPOUND aspirin; carisoprodol TABLET;ORAL 012365-005 Jul 11, 1983 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE aspirin; carisoprodol; codeine phosphate TABLET;ORAL 040118-001 Apr 16, 1996 AB RX No Yes   Start Trial   Start Trial   Start Trial
Galt Pharms ORPHENGESIC aspirin; caffeine; orphenadrine citrate TABLET;ORAL 075141-001 May 29, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs CARISOPRODOL COMPOUND aspirin; carisoprodol TABLET;ORAL 088809-001 Oct 3, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth BUTALBITAL, ASPIRIN AND CAFFEINE aspirin; butalbital; caffeine TABLET;ORAL 086710-002 Aug 23, 1983 DISCN No No   Start Trial   Start Trial   Start Trial
Bayer BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN aspirin TABLET;ORAL 021317-001 Oct 18, 2001 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

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:

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Johnson and Johnson
AstraZeneca
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Express Scripts
Colorcon

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