ASPIRIN; DIPYRIDAMOLE - Generic Drug Details

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What are the generic sources for aspirin; dipyridamole and what is the scope of freedom to operate?

Aspirin; dipyridamole is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim, Amneal Pharms, Ani Pharms, Barr, Chartwell Molecular, Dr Reddys, Endo Operations, Glenmark Speclt, Micro Labs, Sandoz, Sun Pharm, and Zydus Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for ASPIRIN; DIPYRIDAMOLE

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	25
Patent Applications:	92
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ASPIRIN; DIPYRIDAMOLE
DailyMed Link:	ASPIRIN; DIPYRIDAMOLE at DailyMed

Recent Clinical Trials for ASPIRIN; DIPYRIDAMOLE

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

Sponsor	Phase
Rutgers, The State University of New Jersey	Phase 3
Ministry of Health, France	Phase 3
University Hospital, Lille	Phase 3

See all ASPIRIN; DIPYRIDAMOLE clinical trials

Pharmacology for ASPIRIN; DIPYRIDAMOLE

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

Anatomical Therapeutic Chemical (ATC) Classes for ASPIRIN; DIPYRIDAMOLE

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for ASPIRIN; DIPYRIDAMOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AGGRENOX	Extended-release Capsules	aspirin; dipyridamole	25 mg and 200 mg	020884	1	2007-02-01

US Patents and Regulatory Information for ASPIRIN; DIPYRIDAMOLE

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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
Micro Labs	ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	209929-001	Aug 11, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	208572-001	Aug 21, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Speclt	ASPIRIN AND DIPYRIDAMOLE	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	210318-001	May 24, 2019	AB	RX	No	Yes	⤷ 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; DIPYRIDAMOLE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	AGGRENOX	aspirin; dipyridamole	CAPSULE, EXTENDED RELEASE;ORAL	020884-001	Nov 22, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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