Carbamazepine - Generic Drug Details
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What are the generic drug 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 |
Kathmandu University | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Taro | CARBAMAZEPINE | carbamazepine | SUSPENSION;ORAL | 075875-001 | Dec 21, 2000 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Teva Pharms | CARBAMAZEPINE | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 078592-001 | Sep 20, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Torrent Pharms | CARBAMAZEPINE | carbamazepine | TABLET, CHEWABLE;ORAL | 075712-001 | Jul 5, 2001 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Zhejiang Jiuzhou | CARBAMAZEPINE | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 215591-003 | Mar 31, 2022 | 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 |
Takeda Pharms Usa | CARBATROL | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 020712-001 | 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 |
---|---|---|---|
South Africa | 200803332 | NOVEL PARENTERAL CARBAMAZEPINE FORMULATION | ⤷ Try a Trial |
Russian Federation | 2012112839 | НОВАЯ ПАРЕНТЕРАЛЬНАЯ КОМПОЗИЦИЯ КАРБАМАЗЕПИНА | ⤷ Try a Trial |
Japan | 6039721 | ⤷ Try a Trial | |
Japan | 5794966 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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