INDOMETHACIN SODIUM - Generic Drug Details

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What are the generic drug sources for indomethacin sodium and what is the scope of patent protection?

Indomethacin sodium is the generic ingredient in two branded drugs marketed by Recordati Rare, Hospira, Navinta Llc, and West-ward Pharms Int, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for indomethacin sodium.

Summary for INDOMETHACIN SODIUM

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	4
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	10
Patent Applications:	5,245
DailyMed Link:	INDOMETHACIN SODIUM at DailyMed

Recent Clinical Trials for INDOMETHACIN SODIUM

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

Sponsor	Phase
Ciusss de L'Est de l'Île de Montréal	N/A
Second Affiliated Hospital, School of Medicine, Zhejiang University	N/A
Alphacait, LLC	Phase 2

See all INDOMETHACIN SODIUM clinical trials

US Patents and Regulatory Information for INDOMETHACIN SODIUM

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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
Recordati Rare	INDOCIN	indomethacin sodium	INJECTABLE;INJECTION	018878-001	Jan 30, 1985		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
West-ward Pharms Int	INDOMETHACIN SODIUM	indomethacin sodium	INJECTABLE;INJECTION	078713-001	Jul 16, 2008	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Navinta Llc	INDOMETHACIN SODIUM	indomethacin sodium	INJECTABLE;INJECTION	206561-001	Jul 19, 2017	AP	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

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