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, 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
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 8 |
NDAs: | 8 |
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 |
Pharmacology for CEVIMELINE HYDROCHLORIDE
Drug Class | Cholinergic Receptor Agonist |
Mechanism of Action | Cholinergic Muscarinic Agonists |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex Inc | CEVIMELINE HYDROCHLORIDE | cevimeline hydrochloride | CAPSULE;ORAL | 091260-001 | Aug 25, 2011 | DISCN | No | No | ⤷ 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 | |||
Hikma | CEVIMELINE HYDROCHLORIDE | cevimeline hydrochloride | CAPSULE;ORAL | 091591-001 | Jul 8, 2013 | 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
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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