Aspirin - Generic Drug Details

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 Espero, Plx Pharma, Bayer, Savage Labs, Lgm Pharma, 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, Stevens J, Sun Pharm Industries, Sandoz, Bausch, Galt Pharms, Alra, Xanodyne Pharm, Ivax Sub Teva Pharms, Teva, Heritage Pharms, Novast Labs, Oxford Pharms, Meda Pharms, Ingenus Pharms Nj, Boehringer Ingelheim, Amneal Pharms, Ani Pharms, Barr, Dr Reddys, Glenmark Pharms Sa, Lannett Co Inc, Micro Labs, 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-nine NDAs. There are nine 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.

Summary for aspirin

International Patents:	42
US Patents:	9
Tradenames:	53
Applicants:	58
NDAs:	89
Drug Master File Entries:	22
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	1,528
Patent Applications:	6,595
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
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

Recent Clinical Trials for aspirin

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

Sponsor	Phase
China National Center for Cardiovascular Diseases	Phase 4
Regeneron Pharmaceuticals	N/A
Centre Hospitalier Universitaire de Besancon	Phase 2/Phase 3

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
Bristol Myers Squibb	PRAVIGARD PAC (COPACKAGED)	aspirin; pravastatin sodium	TABLET;ORAL	021387-006	Jun 24, 2003		DISCN	No	No
Sun Pharm Industries	OXYCODONE AND ASPIRIN	aspirin; oxycodone hydrochloride; oxycodone terephthalate	TABLET;ORAL	087794-001	May 26, 1982		DISCN	No	No
Endo Pharms	PERCODAN	aspirin; oxycodone hydrochloride	TABLET;ORAL	007337-007	Aug 5, 2005	AA	RX	Yes	Yes

Expired US Patents for aspirin

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

International Patents for aspirin

Country	Patent Number	Title	Estimated Expiration
Japan	2017222650	胃腸管に沿った医薬の標的化放出のためのｐＨ依存性担体、それによる組成物、ならびにこれらの製造および使用 (PH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG THE GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME)
European Patent Office	2760433	VECTEURS DÉPENDANT DU PH POUR LIBÉRATION CIBLÉE DE PRODUITS PHARMACEUTIQUES DANS LE TUBE DIGESTIF, COMPOSITIONS PRÉPARÉES À 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)
Japan	2020090499	胃腸管に沿った医薬の標的化放出のためのｐＨ依存性担体、それによる組成物、ならびにこれらの製造および使用 (pH DEPENDENT CARRIERS FOR TARGETED RELEASE OF PHARMACEUTICALS ALONG GASTROINTESTINAL TRACT, COMPOSITIONS THEREFROM, AND MAKING AND USING SAME)

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