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, Novitium Pharma, Wockhardt Bio Ag, Novartis, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Teva, Anbison Lab, Cspc Ouyi, Riconpharma Llc, Umedica Labs Pvt Ltd, Unique Pharm, Zhejiang Jiuzhou, Zydus Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Unichem, Usl Pharma, Vgyaan, and Warner Chilcott, and is included in forty NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Carbamazepine has seventy-six patent family members in twenty-one countries.
There are twenty-seven drug master file entries for carbamazepine. Forty-four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for carbamazepine
International Patents: | 76 |
US Patents: | 7 |
Tradenames: | 8 |
Applicants: | 28 |
NDAs: | 40 |
Drug Master File Entries: | 27 |
Finished Product Suppliers / Packagers: | 44 |
Raw Ingredient (Bulk) Api Vendors: | 156 |
Clinical Trials: | 171 |
Patent Applications: | 7,015 |
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 |
---|---|
Kathmandu University | Phase 4 |
Asian Pharmaceuticals Pvt. Ltd. | Phase 4 |
Cerevel Therapeutics, LLC | Phase 1 |
Generic filers with tentative approvals for CARBAMAZEPINE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 300MG | CAPSULE, EXTENDED RELEASE; ORAL |
See Plans and Pricing | See Plans and Pricing | 200MG | CAPSULE, EXTENDED RELEASE; ORAL |
See Plans and Pricing | See Plans and Pricing | 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
Drug Class | Mood Stabilizer |
Mechanism of Action | Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Medical Subject Heading (MeSH) Categories for carbamazepine
Paragraph IV (Patent) Challenges 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lundbeck Pharms Llc | CARNEXIV | carbamazepine | SOLUTION;INTRAVENOUS | 206030-001 | Oct 7, 2016 | DISCN | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Zhejiang Jiuzhou | CARBAMAZEPINE | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 215591-002 | Mar 31, 2022 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Taro | CARBAMAZEPINE | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 078115-002 | Mar 31, 2009 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Jubilant Cadista | CARBAMAZEPINE | carbamazepine | TABLET, CHEWABLE;ORAL | 071940-001 | Feb 1, 1988 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-003 | Mar 25, 1996 | See Plans and Pricing | See Plans and Pricing |
Validus Pharms | EQUETRO | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710-002 | Dec 10, 2004 | See Plans and Pricing | See Plans and Pricing |
Novartis | TEGRETOL | carbamazepine | TABLET, CHEWABLE;ORAL | 018281-001 | Approved Prior to Jan 1, 1982 | See Plans and Pricing | See Plans and Pricing |
Validus Pharms | EQUETRO | carbamazepine | CAPSULE, EXTENDED RELEASE;ORAL | 021710-001 | Dec 10, 2004 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for carbamazepine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 4923144 | See Plans and Pricing | |
Russian Federation | 2615385 | КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME RELATED APPLICATIONS) | See Plans and Pricing |
Spain | 2475157 | See Plans and Pricing | |
Canada | 2624463 | NOUVELLE PREPARATION A BASE DE CARBAMAZEPINE A ADMINISTRATION PAR VOIE PARENTERALE (NOVEL PARENTERAL CARBAMAZEPINE FORMULATION) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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