Last Updated: June 22, 2026

CEVIMELINE Drug Patent Profile

Name: CEVIMELINE Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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

Cevimeline is a drug marketed by Apotex Inc, Aurobindo Pharma, Bionpharma, Hikma, Macleods Pharms Ltd, Novel Labs Inc, Rising, Rubicon Research, and Zydus Lifesciences. and is included in nine NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cevimeline

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

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Questions you can ask:

What is the 5 year forecast for CEVIMELINE?
What are the global sales for CEVIMELINE?
What is Average Wholesale Price for CEVIMELINE?

Summary for CEVIMELINE

US Patents:	0
Applicants:	9
NDAs:	9
Drug Prices:	Drug price information for CEVIMELINE
What excipients (inactive ingredients) are in CEVIMELINE?	CEVIMELINE excipients list
DailyMed Link:	CEVIMELINE at DailyMed

Drug patent expirations by year for CEVIMELINE

Recent Clinical Trials for CEVIMELINE

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Sponsor	Phase
BioTheraVision, Inc.	PHASE2
Ain Shams University	PHASE4
China Medical University Hospital	Phase 4

See all CEVIMELINE clinical trials

US Patents and Regulatory Information for CEVIMELINE

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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 Inc	CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	091260-001	Aug 25, 2011		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Rising	CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	203775-001	Jun 4, 2014	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hikma	CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	091591-001	Jul 8, 2013	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

DrugChatter Q&A for CEVIMELINE

Cevimeline patent synthesis?
Cevimeline fda approval 2000?
Cevimeline synthesis patent us?
Cevimeline synthesis patent spiro oxathiolane quinuclidine?
Why is cevimeline so expensive?

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.