Etodolac - Generic Drug Details

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What are the generic 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, Ipca Labs Ltd, Mylan, Natco Pharma, Sandoz, Taro, Wyeth Pharms Inc, Actavis Elizabeth, Bayshore Pharms Llc, Teva, Watson Labs Florida, Zydus Pharms, Abraxeolus, Adaptis, Amneal Pharms Co, Apotex Inc, Ivax Sub Teva Pharms, Oxford Pharms, Ranbaxy Labs Ltd, Shree Hari Intl, Taro Pharm Inds, and Watson Labs, and is included in forty-one NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for etodolac

US Patents:	0
Tradenames:	3
Applicants:	25
NDAs:	41
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	29
Patent Applications:	6,966
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

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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

Anatomical Therapeutic Chemical (ATC) Classes for etodolac

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 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
Apotex	ETODOLAC	etodolac	CAPSULE;ORAL	075419-002	Jul 28, 2000	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	ETODOLAC	etodolac	TABLET;ORAL	075009-001	Nov 26, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	ETODOLAC	etodolac	TABLET, EXTENDED RELEASE;ORAL	091134-003	Jan 23, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	ETODOLAC	etodolac	TABLET, EXTENDED RELEASE;ORAL	091134-002	Jan 23, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex Inc	ETODOLAC	etodolac	TABLET;ORAL	076004-002	Dec 3, 2002	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	ETODOLAC	etodolac	CAPSULE;ORAL	075419-001	Jul 28, 2000	AB	RX	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 etodolac

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-002	Jan 31, 1991	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-003	Jan 31, 1991	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-001	Oct 25, 1996	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms Inc	LODINE	etodolac	TABLET;ORAL	018922-004	Jul 29, 1993	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-002	Oct 25, 1996	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-003	Jan 20, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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