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Aspirin - Generic Drug Details

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Aspirin is the generic ingredient in fifty-three branded drugs marketed by Bayer, New Haven Pharms, Plx Pharma, Savage Labs, Actavis Elizabeth, Watson Labs, Allergan Sales Llc, Ivax Pharms, Halsey, Puracap Pharm, Nostrum Labs Inc, Hikma Intl Pharms, Quantum Pharmics, Lannett, Pharmaceutics Intl, Sandoz, Nexgen Pharma Inc, Mayne Pharma Inc, Stevens J, Vintage Pharms Llc, Sun Pharm Inds, Medicis, Prinston Inc, Teva, Alra, Ivax Sub Teva Pharms, Xanodyne Pharm, Ingenus Pharms Nj, Oxford Pharms, Meda Pharms, Heritage Pharms Inc, Barr, Boehringer Ingelheim, Amneal Pharms, Schwarz Pharma, Abbott, Caraco, Par Pharm, Medpointe Pharm Hlc, Robins Ah, Mcneil, Aralez Pharms, Endo Pharms, Actavis Labs Fl Inc, Roxane, Sanofi Aventis Us, Bristol Myers Squibb, and Aaipharma Llc, and is included in seventy-seven NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-eight patent family members in eighteen countries.

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

Summary for Generic Name: aspirin

Tradenames:53
Patents:9
Applicants:48
NDAs:77
Drug Master File Entries: see list21
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: aspirin

Tentative approvals for ASPIRIN

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, EXTENDED RELEASE;ORAL25MG;200MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds
OXYCODONE AND ASPIRIN
aspirin; oxycodone hydrochloride; oxycodone terephthalate
TABLET;ORAL087794-001May 26, 1982DISCNNo► subscribe► subscribe
Meda Pharms
SOMA COMPOUND
aspirin; carisoprodol
TABLET;ORAL012365-005Jul 11, 1983DISCNNo► subscribe► subscribe
Sandoz
CARISOPRODOL AND ASPIRIN
aspirin; carisoprodol
TABLET;ORAL040116-001Apr 25, 1996RXNo► subscribe► subscribe
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Non-Orange Book Patents for Generic Ingredient: aspirin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,911,752Methods of making compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: aspirin

Country Document Number Estimated Expiration
Japan2014531460► subscribe
Australia2012315545► subscribe
South Korea100884493► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ASPIRIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
12/048Ireland► subscribePRODUCT 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
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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 verifification 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.

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