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Details for Generic Name: cevimeline hydrochloride

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Cevimeline hydrochloride is the generic ingredient in three branded drugs marketed by Apotex Inc, Pack Pharms Llc, Roxane, and Daiichi Sankyo, and is included in four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: cevimeline hydrochloride

Tradenames:3
Patents:1
Applicants:4
NDAs:4
Drug Master File Entries: see list4
Suppliers: see list3
Therapeutic Class:Dental and Oral Agents

Pharmacology for Ingredient: cevimeline hydrochloride

Clinical Trials for: cevimeline hydrochloride

Study of the Effectiveness of Cevimeline on Oral Health in Patients With Radiation Induced Xerostomia
Status: Completed Condition: Xerostomia

Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions
Status: Completed Condition: Dry Mouth

Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva
Status: Completed Condition: Dry Mouth

Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions
Status: Completed Condition: Dry Mouth

Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
Status: Completed Condition: Head and Neck Cancer; Oral Complications; Radiation Toxicity

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane
CEVIMELINE HYDROCHLORIDE
cevimeline hydrochloride
CAPSULE;ORAL091591Jul 8, 2013RXNo<disabled><disabled>
Apotex Inc
CEVIMELINE
cevimeline hydrochloride
CAPSULE;ORAL091260Aug 25, 2011RXNo<disabled><disabled>
Pack Pharms Llc
CEVIMELINE HYDROCHLORIDE
cevimeline hydrochloride
CAPSULE;ORAL203775Jun 4, 2014RXNo<disabled><disabled>
Daiichi Sankyo
EVOXAC
cevimeline hydrochloride
CAPSULE;ORAL020989Jan 11, 2000RXYes5,340,821<disabled><disabled>
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