CARBAMAZEPINE - Generic Drug Details
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What are the generic drug sources for carbamazepine and what is the scope of freedom to operate?
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, Apotex, 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-five 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: | 33 |
NDAs: | 45 |
Drug Master File Entries: | 27 |
Finished Product Suppliers / Packagers: | 46 |
Raw Ingredient (Bulk) Api Vendors: | 164 |
Clinical Trials: | 182 |
Patent Applications: | 6,705 |
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 |
---|---|
Alexion Pharmaceuticals, Inc. | Phase 1 |
Arvinas Estrogen Receptor, Inc. | Phase 1 |
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Phase 1 |
Generic filers with tentative approvals for CARBAMAZEPINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 300MG | CAPSULE, EXTENDED RELEASE; ORAL |
⤷ Sign Up | ⤷ Sign Up | 200MG | CAPSULE, EXTENDED RELEASE; ORAL |
⤷ Sign Up | ⤷ Sign Up | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex Inc | CARBAMAZEPINE | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 078986-003 | Nov 25, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Anbison Lab | CARBAMAZEPINE | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 212948-001 | Sep 30, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Zydus Pharms | CARBAMAZEPINE | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 205571-001 | Feb 7, 2019 | 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 CARBAMAZEPINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Validus Pharms | EQUETRO | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710-001 | Dec 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-001 | Mar 25, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-001 | Sep 30, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CARBAMAZEPINE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2452588 | METHODE DE TRAITEMENT DE TROUBLES AFFECTIFS BIPOLAIRES A L'AIDE DE CARBAMAZEPINE (METHODS FOR THE TREATMENT OF BIPOLAR DISORDER USING CARBAMAZEPINE) | ⤷ Sign Up |
Japan | 2010539193 | ⤷ Sign Up | |
Spain | 2475157 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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