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Last Updated: April 20, 2024

Etodolac - Generic Drug Details

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

Etodolac is the generic ingredient in three branded drugs marketed by Ani Pharms, Apotex, Biopharm, Chartwell Molecules, Mylan, Sandoz, Taro, Wyeth Pharms Inc, Actavis Elizabeth, Bayshore Pharms Llc, Teva, Watson Labs Florida, Zydus Pharms, Amneal Pharms Co, Apotex Inc, Edenbridge Pharms, Ivax Sub Teva Pharms, Oxford Pharms, Ranbaxy Labs Ltd, Shree Hari Intl, Taro Pharm Inds, and Watson Labs, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for etodolac. Thirty suppliers are listed for this compound.

Summary for etodolac

US Patents:	0
Tradenames:	3
Applicants:	22
NDAs:	39
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	29
Patent Applications:	7,314
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for etodolac
Drug Sales Revenues:	Drug sales revenues for etodolac
What excipients (inactive ingredients) are in etodolac?	etodolac excipients list
DailyMed Link:	etodolac at DailyMed

See drug prices for etodolac

See drug sales revenues for etodolac

Recent Clinical Trials for etodolac

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

Sponsor	Phase
Kutahya Health Sciences University	Phase 4
Memorial Sloan Kettering Cancer Center	N/A
Apsen Farmaceutica S.A.	Phase 3

See all etodolac clinical trials

Pharmacology for etodolac

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

Medical Subject Heading (MeSH) Categories for etodolac

Cyclooxygenase 2 Inhibitors

US Patents and Regulatory Information for etodolac

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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
Taro	ETODOLAC	etodolac	TABLET, EXTENDED RELEASE;ORAL	076174-003	Mar 13, 2003	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	ETODOLAC	etodolac	TABLET;ORAL	074892-002	Oct 29, 1998		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	ETODOLAC	etodolac	TABLET;ORAL	074903-001	Apr 11, 1997	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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 etodolac

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-003	Jan 31, 1991	⤷ Try a Trial	⤷ Try a Trial
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-003	Jan 31, 1991	⤷ Try a Trial	⤷ Try a Trial
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-001	Oct 25, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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