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Last Updated: October 31, 2024

CEVIMELINE HYDROCHLORIDE - Generic Drug Details


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

Cevimeline hydrochloride is the generic ingredient in two branded drugs marketed by Apotex Inc, Aurobindo Pharma, Bionpharma, Hikma, Novel Labs Inc, Rising, Rubicon, and Cosette, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for cevimeline hydrochloride. Ten suppliers are listed for this compound.

Summary for CEVIMELINE HYDROCHLORIDE
US Patents:0
Tradenames:2
Applicants:8
NDAs:8
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 10
Raw Ingredient (Bulk) Api Vendors: 88
Clinical Trials: 6
Patent Applications: 89
What excipients (inactive ingredients) are in CEVIMELINE HYDROCHLORIDE?CEVIMELINE HYDROCHLORIDE excipients list
DailyMed Link:CEVIMELINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for CEVIMELINE HYDROCHLORIDE

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

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novel Labs Inc CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 204746-001 Dec 30, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 091591-001 Jul 8, 2013 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 CEVIMELINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cosette EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000 ⤷  Sign Up ⤷  Sign Up
Cosette EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000 ⤷  Sign Up ⤷  Sign Up
Cosette EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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