CEVIMELINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Cevimeline Hydrochloride, and what generic alternatives are available?
Cevimeline Hydrochloride is a drug marketed by Apotex Inc, Aurobindo Pharma, Bionpharma, Hikma, Macleods Pharms Ltd, Novel Labs Inc, Rising, and Rubicon. and is included in eight NDAs.
The generic ingredient in CEVIMELINE HYDROCHLORIDE is cevimeline hydrochloride. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cevimeline hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Cevimeline Hydrochloride
A generic version of CEVIMELINE HYDROCHLORIDE was approved as cevimeline hydrochloride by HIKMA on July 8th, 2013.
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Questions you can ask:
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- What is Average Wholesale Price for CEVIMELINE HYDROCHLORIDE?
Summary for CEVIMELINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 6 |
| Patent Applications: | 63 |
| 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 | ||||
| Rising | CEVIMELINE HYDROCHLORIDE | cevimeline hydrochloride | CAPSULE;ORAL | 203775-001 | Jun 4, 2014 | 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 |
