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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 thirty-nine patent family members in eighteen countries.

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

Summary for aspirin

International Patents:	39
US Patents:	10
Tradenames:	52
Applicants:	58
NDAs:	86
Drug Master File Entries:	22
Bulk Api Vendors:	121
Clinical Trials:	1,384
Patent Applications:	6,128
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

See drug prices for aspirin

See drug sales revenues for aspirin

Recent Clinical Trials for aspirin

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

Sponsor	Phase
Taizhou Enze Hospital	N/A
The Central Hospital of Lishui City	N/A
Boston Scientific Corporation	N/A

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE	aspirin; carisoprodol; codeine phosphate	TABLET;ORAL	040118-001	Apr 16, 1996	AB	RX	No	Yes
Stevens J	ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE	aspirin; caffeine; orphenadrine citrate	TABLET;ORAL	074988-001	Apr 30, 1999		DISCN	No	No
Abbott	VICOPRIN	aspirin; hydrocodone bitartrate	TABLET;ORAL	086333-001	Sep 14, 1983		DISCN	No	No

International Patents for aspirin

Country	Patent Number	Estimated Expiration
Japan	4958381
Japan	6368645
South Korea	102162901

Supplementary Protection Certificates for aspirin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	2012/048	Ireland		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
0984957	122012000017	Germany		PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812