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.

Summary for aspirin

International Patents:	37
US Patents:	10
Tradenames:	52
Applicants:	57
NDAs:	85
Drug Master File Entries:	22
Bulk Api Vendors:	112
Clinical Trials:	1,342
Patent Applications:	6,876
Formulation / Manufacturing:	see details
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
DailyMed Link:	aspirin at DailyMed

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See drug sales revenues for aspirin

Recent Clinical Trials for aspirin

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

Sponsor	Phase
Centre Hospitalier Intercommunal Creteil	Phase 3
Christian Torp-Pedersen	Phase 4
Aarhus University Hospital	Phase 4

See all aspirin clinical trials

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
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

International Patents for aspirin

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Country	Patent Number	Estimated Expiration
Canada	2431606	Start Trial
Japan	2014531460	Start Trial
Cyprus	1110474	Start Trial
Brazil	0116380	Start Trial
Japan	4958381	Start Trial
>Country	>Patent Number	>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	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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