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, Macleods Pharms Ltd, Novel Labs Inc, Rising, Rubicon, and Cosette, and is included in nine 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:	9
NDAs:	9
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

Sponsor	Phase
China Medical University Hospital	Phase 4
Roxane Laboratories	Early Phase 1
University of Kentucky	N/A

See all CEVIMELINE HYDROCHLORIDE clinical trials

Pharmacology for CEVIMELINE HYDROCHLORIDE

Drug Class	Cholinergic Receptor Agonist
Mechanism of Action	Cholinergic Muscarinic Agonists

Anatomical Therapeutic Chemical (ATC) Classes for CEVIMELINE HYDROCHLORIDE

N07AX	Other parasympathomimetics
N07A	PARASYMPATHOMIMETICS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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

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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
Hikma	CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	091591-001	Jul 8, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	EVOXAC	cevimeline hydrochloride	CAPSULE;ORAL	020989-002	Jan 11, 2000	AB	RX	Yes	Yes	⤷ 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
>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

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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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