You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Cevimeline hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for cevimeline hydrochloride and what is the scope of patent protection?

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
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
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
Cosette EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000 AB RX Yes Yes ⤷  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
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
Novel Labs Inc CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 204746-001 Dec 30, 2016 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 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 ⤷  Try a Trial ⤷  Try a Trial
Cosette EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000 ⤷  Try a Trial ⤷  Try a Trial
Cosette EVOXAC cevimeline hydrochloride CAPSULE;ORAL 020989-002 Jan 11, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.