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-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, Esjay Pharma, Stevens J, Sun Pharm Industries, Bausch, Galt Pharms, Alra, Xanodyne Pharm, Ivax Sub Teva Pharms, Teva, Chartwell Rx, Genus, Novast Labs, Oxford Pharms, Meda Pharms, Ingenus Pharms Nj, Boehringer Ingelheim, Amneal Pharms, Ani Pharms, Barr, Chartwell Molecular, Dr Reddys, Endo Operations, Glenmark Speclt, Micro Labs, Sun Pharm, Zydus Pharms, Schwarz Pharma, Abbott, Par Pharm, Medpointe Pharm Hlc, Mcneil, Robins Ah, Genus Lifesciences, Actavis Labs Fl Inc, Epic Pharma Llc, 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.

Summary for aspirin

International Patents:	20
US Patents:	6
Tradenames:	53
Applicants:	58
NDAs:	89
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	1,599
Patent Applications:	6,580
Drug Prices:	Drug price trends for aspirin
Drug Sales Revenues:	Drug sales revenues for aspirin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aspirin
What excipients (inactive ingredients) are in aspirin?	aspirin excipients list
DailyMed Link:	aspirin at DailyMed

See drug prices for aspirin

See drug sales revenues for aspirin

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for aspirin

Generic Entry Date for aspirin^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Zunyi Medical College	Phase 4
Assistance Publique Hopitaux De Marseille	N/A
Indian Council of Medical Research	Phase 3

See all aspirin clinical trials

Generic filers with tentative approvals for ASPIRIN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	325MG;40MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	81MG;40MG	TABLET;ORAL

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

Pharmacology for aspirin

Drug Class	Nonsteroidal Anti-inflammatory Drug Platelet Aggregation Inhibitor
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Decreased Platelet Aggregation Decreased Prostaglandin Production

Medical Subject Heading (MeSH) Categories for aspirin

Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Cyclooxygenase Inhibitors
Fibrinolytic Agents
Platelet Aggregation Inhibitors

US Patents and Regulatory Information for aspirin

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	PROPOXYPHENE COMPOUND 65	aspirin; caffeine; propoxyphene hydrochloride	CAPSULE;ORAL	080044-002	Sep 16, 1983		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	OXYCODONE AND ASPIRIN	aspirin; oxycodone hydrochloride	TABLET;ORAL	040910-001	Jul 16, 2020	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-001	Jun 24, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ivax Pharms	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	085441-002	Oct 31, 1984		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

International Patents for aspirin

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Country	Patent Number	Title	Estimated Expiration
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.)	⤷ Sign Up
Australia	2012315545	pH dependent carriers for targeted release of pharmaceuticals along the gastrointestinal tract, compositions therefrom, and making and using same	⤷ Sign Up
Canada	2850187		⤷ Sign Up
Canada	2850187	VECTEURS DEPENDANT DU PH POUR LIBERATION CIBLEE DE PRODUITS PHARMACEUTIQUES DANS LE TUBE DIGESTIF, COMPOSITIONS PREPAREES A PARTIR DE CEUX-CI, ET LEUR FABRICATION ET LEUR UTILISATION (PH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for aspirin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	122012000017	Germany	⤷ Sign Up	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	⤷ Sign Up	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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