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Last Updated: November 2, 2024

Sulindac - Generic Drug Details

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

Sulindac is the generic ingredient in two branded drugs marketed by Merck, Ani Pharms, Chartwell Rx, Epic Pharma, Epic Pharma Llc, Rising, Sun Pharm Industries, and Watson Labs, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for sulindac. Nine suppliers are listed for this compound.

Summary for sulindac

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	12
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	32
Patent Applications:	6,581
Drug Prices:	Drug price trends for sulindac
Drug Sales Revenues:	Drug sales revenues for sulindac
What excipients (inactive ingredients) are in sulindac?	sulindac excipients list
DailyMed Link:	sulindac at DailyMed

Drug Prices for sulindac

See drug prices for sulindac

Drug Sales Revenue Trends for sulindac

See drug sales revenues for sulindac

Recent Clinical Trials for sulindac

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

Sponsor	Phase
Healx Limited	Phase 2
Duke University	Phase 2
Memorial Sloan Kettering Cancer Center	Phase 2

See all sulindac clinical trials

Pharmacology for sulindac

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

Medical Subject Heading (MeSH) Categories for sulindac

Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for sulindac

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

US Patents and Regulatory Information for sulindac

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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
Sun Pharm Industries	SULINDAC	sulindac	TABLET;ORAL	072051-001	Apr 17, 1991	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	SULINDAC	sulindac	TABLET;ORAL	071795-001	Apr 3, 1990	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	SULINDAC	sulindac	TABLET;ORAL	073262-002	Sep 6, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	SULINDAC	sulindac	TABLET;ORAL	073039-002	Jun 22, 1993		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	SULINDAC	sulindac	TABLET;ORAL	072050-001	Apr 17, 1991	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma	SULINDAC	sulindac	TABLET;ORAL	072711-001	Mar 25, 1991	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-002	Approved Prior to Jan 1, 1982		DISCN	Yes	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 sulindac

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Merck	CLINORIL	sulindac	TABLET;ORAL	017911-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.