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Last Updated: June 14, 2021

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ETODOLAC Drug Profile


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When do Etodolac patents expire, and when can generic versions of Etodolac launch?

Etodolac is a drug marketed by Ani Pharms Inc, Apotex, Biopharm, Chartwell Molecules, Mylan, Sandoz, Taro, Actavis Elizabeth, Bayshore Pharms Llc, Teva, Watson Labs Florida, Zydus Pharms, Amneal Pharms Co, Apotex Inc, Edenbridge Pharms, Ivax Sub Teva Pharms, Oxford Pharms, Pharmgen, Ranbaxy Labs Ltd, Taro Pharm Inds, and Watson Labs. and is included in thirty-seven NDAs.

The generic ingredient in ETODOLAC is etodolac. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the etodolac profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Etodolac

A generic version of ETODOLAC was approved as etodolac by SANDOZ on April 11th, 1997.

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Drug patent expirations by year for ETODOLAC
Drug Prices for ETODOLAC

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Drug Sales Revenue Trends for ETODOLAC

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Recent Clinical Trials for ETODOLAC

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

SponsorPhase
Rabin Medical CenterPhase 2
Assaf-Harofeh Medical CenterPhase 2
Rambam Health Care CampusPhase 2

See all ETODOLAC clinical trials

Pharmacology for ETODOLAC
Medical Subject Heading (MeSH) Categories for ETODOLAC
Paragraph IV (Patent) Challenges for ETODOLAC
Tradename Dosage Ingredient NDA Submissiondate
LODINE XL TABLET, EXTENDED RELEASE;ORAL etodolac 020584

US Patents and Regulatory Information for ETODOLAC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs ETODOLAC etodolac TABLET;ORAL 074892-002 Oct 29, 1998 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Amneal Pharms Co ETODOLAC etodolac TABLET;ORAL 208834-002 Jun 7, 2018 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Teva ETODOLAC etodolac TABLET, EXTENDED RELEASE;ORAL 075665-003 Feb 5, 2001 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Edenbridge Pharms ETODOLAC etodolac TABLET;ORAL 209888-002 Nov 30, 2018 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Ranbaxy Labs Ltd ETODOLAC etodolac TABLET;ORAL 075226-001 Nov 24, 1998 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Bayshore Pharms Llc ETODOLAC etodolac TABLET;ORAL 210704-002 Dec 16, 2020 AB RX No No   Get Started Free   Get Started Free   Get Started Free
>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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