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Last Updated: March 19, 2024

CEVIMELINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Cevimeline Hydrochloride, and what generic alternatives are available?

Cevimeline Hydrochloride is a drug marketed by Apotex Inc, Aurobindo Pharma, Bionpharma, Hikma, Novel Labs Inc, Rising, and Rubicon. and is included in seven NDAs.

The generic ingredient in CEVIMELINE HYDROCHLORIDE is cevimeline hydrochloride. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cevimeline hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cevimeline Hydrochloride

A generic version of CEVIMELINE HYDROCHLORIDE was approved as cevimeline hydrochloride by HIKMA on July 8th, 2013.

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Summary for CEVIMELINE HYDROCHLORIDE
Drug patent expirations by year for CEVIMELINE HYDROCHLORIDE
Recent Clinical Trials for CEVIMELINE HYDROCHLORIDE

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SponsorPhase
China Medical University HospitalPhase 4
Roxane LaboratoriesEarly Phase 1
University of KentuckyN/A

See all CEVIMELINE HYDROCHLORIDE clinical trials

Pharmacology for CEVIMELINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for CEVIMELINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for CEVIMELINE HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EVOXAC Capsules cevimeline hydrochloride 30 mg 020989 1 2009-02-27

US Patents and Regulatory Information for CEVIMELINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 091260-001 Aug 25, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rubicon CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 216682-001 Apr 6, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 091591-001 Jul 8, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 215056-001 Apr 18, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bionpharma CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 218290-001 Nov 8, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 203775-001 Jun 4, 2014 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

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