INDOCIN Drug Patent Profile

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Indocin is a drug marketed by Zyla Life Sciences, Recordati Rare, and Zyla. and is included in five NDAs.

The generic ingredient in INDOCIN is indomethacin sodium. There are fifteen drug master file entries for this compound. Additional details are available on the indomethacin sodium profile page.

A generic version of INDOCIN was approved as indomethacin sodium by WEST-WARD PHARMS INT on July 16^th, 2008.

US Patents:	0
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	22
Patent Applications:	4,392
Drug Prices:	Drug price information for INDOCIN
What excipients (inactive ingredients) are in INDOCIN?	INDOCIN excipients list
DailyMed Link:	INDOCIN at DailyMed

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

Sponsor	Phase
Johns Hopkins University	Phase 3
MetroHealth Medical Center	Early Phase 1
National Cancer Institute (NCI)	Phase 2

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

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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
Zyla Life Sciences	INDOCIN	indomethacin	CAPSULE;ORAL	016059-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zyla Life Sciences	INDOCIN	indomethacin	CAPSULE;ORAL	016059-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Recordati Rare	INDOCIN	indomethacin sodium	INJECTABLE;INJECTION	018878-001	Jan 30, 1985		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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984	⤷ Sign Up	⤷ Sign Up
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

See the table below for patents covering INDOCIN around the world.

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Country	Patent Number	Title	Estimated Expiration
South Africa	7207134		⤷ Sign Up
Netherlands	144482		⤷ Sign Up
Denmark	125306		⤷ Sign Up
Australia	472229		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration