DIFLUNISAL - Generic Drug Details

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What are the generic sources for diflunisal and what is the scope of freedom to operate?

Diflunisal is the generic ingredient in two branded drugs marketed by Ani Pharms, Dastech Intl, Heritage Pharma, Purepac Pharm, Teva, Watson Labs, Zydus Pharms, and Merck, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for diflunisal. Six suppliers are listed for this compound.

Summary for DIFLUNISAL

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	10
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	6
Patent Applications:	7,247
Drug Prices:	Drug price trends for DIFLUNISAL
What excipients (inactive ingredients) are in DIFLUNISAL?	DIFLUNISAL excipients list
DailyMed Link:	DIFLUNISAL at DailyMed

See drug prices for DIFLUNISAL

Drug Sales Revenue Trends for DIFLUNISAL

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Recent Clinical Trials for DIFLUNISAL

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

Sponsor	Phase
Bristol-Myers Squibb	Phase 1
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all DIFLUNISAL clinical trials

Pharmacology for DIFLUNISAL

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for DIFLUNISAL

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DIFLUNISAL

N02BA	Salicylic acid and derivatives
N02B	OTHER ANALGESICS AND ANTIPYRETICS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for DIFLUNISAL

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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
Watson Labs	DIFLUNISAL	diflunisal	TABLET;ORAL	074400-001	Jul 17, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heritage Pharma	DIFLUNISAL	diflunisal	TABLET;ORAL	202845-002	Aug 16, 2024		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	DIFLUNISAL	diflunisal	TABLET;ORAL	203547-001	Jun 16, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	DIFLUNISAL	diflunisal	TABLET;ORAL	073679-001	Jul 31, 1992		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 DIFLUNISAL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	DOLOBID	diflunisal	TABLET;ORAL	018445-001	Apr 19, 1982	⤷ Sign Up	⤷ Sign Up
Merck	DOLOBID	diflunisal	TABLET;ORAL	018445-002	Apr 19, 1982	⤷ Sign Up	⤷ Sign Up
Merck	DOLOBID	diflunisal	TABLET;ORAL	018445-002	Apr 19, 1982	⤷ Sign Up	⤷ Sign Up
Merck	DOLOBID	diflunisal	TABLET;ORAL	018445-001	Apr 19, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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