Carbamazepine - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for carbamazepine and what is the scope of patent protection?
Carbamazepine
is the generic ingredient in eight branded drugs marketed by Apotex Inc, Nostrum Labs Inc, Taro, Teva Pharms, Takeda Pharms Usa, Validus Pharms, Lundbeck Pharms Llc, Chartwell Rx, Novitium Pharma, Novartis, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Teva, Ajanta Pharma Ltd, Amneal Pharms, Anbison Lab, Cspc Ouyi, Riconpharma Llc, Sciecure Pharma Inc, Umedica, Unique Pharm, Zhejiang Jiuzhou, Zydus Pharms, Actavis Elizabeth, Bionpharma, Inwood Labs, Pliva, Rk Pharma, Unichem, Usl Pharma, and Warner Chilcott, and is included in forty-four NDAs. There are eight patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Carbamazepine has seventy-eight patent family members in twenty-one countries.
There are twenty-seven drug master file entries for carbamazepine. Forty-six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for carbamazepine
| International Patents: | 78 |
| US Patents: | 8 |
| Tradenames: | 8 |
| Applicants: | 32 |
| NDAs: | 44 |
| Drug Master File Entries: | 27 |
| Finished Product Suppliers / Packagers: | 46 |
| Raw Ingredient (Bulk) Api Vendors: | 164 |
| Clinical Trials: | 176 |
| Patent Applications: | 6,998 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for carbamazepine |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for carbamazepine |
| What excipients (inactive ingredients) are in carbamazepine? | carbamazepine excipients list |
| DailyMed Link: | carbamazepine at DailyMed |
Recent Clinical Trials for carbamazepine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Aligos Therapeutics | Phase 1 |
| Dr Cipto Mangunkusumo General Hospital | Phase 4 |
| Asian Pharmaceuticals Pvt. Ltd. | Phase 4 |
Generic filers with tentative approvals for CARBAMAZEPINE
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | 300MG | CAPSULE, EXTENDED RELEASE; ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 200MG | CAPSULE, EXTENDED RELEASE; ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 100MG | CAPSULE, EXTENDED RELEASE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for carbamazepine
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| EQUETRO | Extended-release Capsules | carbamazepine | 100 mg | 021710 | 1 | 2014-05-23 |
| EQUETRO | Extended-release Capsules | carbamazepine | 200 mg and 300 mg | 021710 | 1 | 2007-08-21 |
| CARBATROL | Extended-release Capsules | carbamazepine | 100 mg and 200 mg | 020712 | 1 | 2006-02-02 |
| TEGRETOL-XR | Extended-release Tablets | carbamazepine | 100 mg | 020234 | 1 | 2005-12-30 |
US Patents and Regulatory Information for carbamazepine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Unique Pharm | CARBAMAZEPINE | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 211623-003 | Apr 24, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Cspc Ouyi | CARBAMAZEPINE | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 213311-002 | Apr 13, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | CARBAMAZEPINE | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 205571-003 | Feb 7, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 carbamazepine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | TEGRETOL | carbamazepine | TABLET;ORAL | 016608-001 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Validus Pharms | EQUETRO | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710-001 | Dec 10, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-002 | Sep 30, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for carbamazepine
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2018052991 | スルホアルキルエーテルシクロデキストリン組成物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) | ⤷ Try a Trial |
| South Korea | 20200106100 | 알킬화된 시클로덱스트린 조성물 및 이의 제조 및 사용 방법 (Alkylated Cyclodextrin Compositions and Processes for Preparing and using the same) | ⤷ Try a Trial |
| European Patent Office | 2444090 | Nouvelle formulation parentérale de carbamazépine (Novel parenteral carbamazepine formulation) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
