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Cevimeline hydrochloride - Generic Drug Details

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Cevimeline hydrochloride is the generic ingredient in three branded drugs marketed by Apotex Inc, Pack Pharms Llc, Daiichi Sankyo, and Roxane, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: cevimeline hydrochloride

Tradenames:3
Patents:0
Applicants:4
NDAs:4
Drug Master File Entries: see list4
Suppliers / Packaging: see list8
Therapeutic Class:Dental and Oral Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: cevimeline hydrochloride

Clinical Trials for: cevimeline hydrochloride

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;ORAL091591-001Jul 8, 2013RXNo<disabled><disabled>
Pack Pharms Llc
CEVIMELINE HYDROCHLORIDE
cevimeline hydrochloride
CAPSULE;ORAL203775-001Jun 4, 2014RXNo<disabled><disabled>
Daiichi Sankyo
EVOXAC
cevimeline hydrochloride
CAPSULE;ORAL020989-002Jan 11, 2000RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: cevimeline hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Daiichi Sankyo
EVOXAC
cevimeline hydrochloride
CAPSULE;ORAL020989-002Jan 11, 20004,855,290<disabled>
Daiichi Sankyo
EVOXAC
cevimeline hydrochloride
CAPSULE;ORAL020989-002Jan 11, 20005,580,880<disabled>
Daiichi Sankyo
EVOXAC
cevimeline hydrochloride
CAPSULE;ORAL020989-002Jan 11, 20005,340,821<disabled>
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