CARBAMAZEPINE Drug Patent Profile
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When do Carbamazepine patents expire, and when can generic versions of Carbamazepine launch?
Carbamazepine is a drug marketed by Apotex Inc, Nostrum Labs Inc, Taro, Teva Pharms, Chartwell Rx, Novitium Pharma, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, 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 thirty-three NDAs.
The generic ingredient in CARBAMAZEPINE is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Carbamazepine
A generic version of CARBAMAZEPINE was approved as carbamazepine by TARO on October 3rd, 1996.
Summary for CARBAMAZEPINE
| US Patents: | 0 |
| Applicants: | 27 |
| NDAs: | 33 |
| Finished Product Suppliers / Packagers: | 38 |
| Raw Ingredient (Bulk) Api Vendors: | 164 |
| Clinical Trials: | 176 |
| Patent Applications: | 3,030 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
See drug prices for CARBAMAZEPINE
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 |
Pharmacology for CARBAMAZEPINE
Medical Subject Heading (MeSH) Categories for CARBAMAZEPINE
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Umedica | CARBAMAZEPINE | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 216594-001 | Aug 18, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Riconpharma Llc | CARBAMAZEPINE | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 216404-001 | Dec 2, 2022 | 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 | |||
| Torrent Pharms | CARBAMAZEPINE | carbamazepine | TABLET;ORAL | 077272-001 | Dec 7, 2005 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Unique Pharm | CARBAMAZEPINE | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 211623-002 | Apr 24, 2020 | 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 |
