Cevimeline hydrochloride - Generic Drug Details
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What are the generic 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| Aurobindo Pharma | CEVIMELINE HYDROCHLORIDE | cevimeline hydrochloride | CAPSULE;ORAL | 215056-001 | Apr 18, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bionpharma | CEVIMELINE HYDROCHLORIDE | cevimeline hydrochloride | CAPSULE;ORAL | 218290-001 | Nov 8, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex Inc | CEVIMELINE HYDROCHLORIDE | cevimeline hydrochloride | CAPSULE;ORAL | 091260-001 | Aug 25, 2011 | DISCN | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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