OXCARBAZEPINE Drug Patent Profile
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When do Oxcarbazepine patents expire, and what generic alternatives are available?
Oxcarbazepine is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aucta, Biocon Pharma, Bionpharma, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Medley Pharms, Renew Pharms, Rubicon, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Apotex, Ani Pharms, Annora Pharma, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, and Zydus. and is included in twenty-five NDAs.
The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Oxcarbazepine
A generic version of OXCARBAZEPINE was approved as oxcarbazepine by GLENMARK PHARMS LTD on October 9th, 2007.
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Summary for OXCARBAZEPINE
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 25 |
| Finished Product Suppliers / Packagers: | 32 |
| Raw Ingredient (Bulk) Api Vendors: | 130 |
| Clinical Trials: | 63 |
| Patent Applications: | 5,298 |
| Drug Prices: | Drug price information for OXCARBAZEPINE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OXCARBAZEPINE |
| What excipients (inactive ingredients) are in OXCARBAZEPINE? | OXCARBAZEPINE excipients list |
| DailyMed Link: | OXCARBAZEPINE at DailyMed |
See drug prices for OXCARBAZEPINE
Recent Clinical Trials for OXCARBAZEPINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dr Cipto Mangunkusumo General Hospital | Phase 4 |
| Wayne State University | Phase 4 |
| Postgraduate Institute of Dental Sciences Rohtak | Phase 4 |
Pharmacology for OXCARBAZEPINE
| Drug Class | Anti-epileptic Agent |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for OXCARBAZEPINE
Paragraph IV (Patent) Challenges for OXCARBAZEPINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| OXTELLAR XR | Extended-release Tablets | oxcarbazepine | 150 mg and 300 mg | 202810 | 1 | 2013-04-12 |
| OXTELLAR XR | Extended-release Tablets | oxcarbazepine | 600 mg | 202810 | 1 | 2013-03-20 |
| TRILEPTAL | Oral Suspension | oxcarbazepine | 300 mg/5 mL | 021285 | 1 | 2006-12-26 |
| TRILEPTAL | Tablets | oxcarbazepine | 150 mg, 300 mg and 600 mg | 021014 | 1 | 2006-05-05 |
US Patents and Regulatory Information for OXCARBAZEPINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rubicon | OXCARBAZEPINE | oxcarbazepine | TABLET;ORAL | 077747-003 | Apr 9, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | OXCARBAZEPINE | oxcarbazepine | TABLET;ORAL | 077795-002 | Oct 9, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus | OXCARBAZEPINE | oxcarbazepine | TABLET;ORAL | 211747-001 | Jul 3, 2023 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm Inds | OXCARBAZEPINE | oxcarbazepine | TABLET;ORAL | 077794-003 | Oct 9, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus | OXCARBAZEPINE | oxcarbazepine | TABLET;ORAL | 211747-002 | Jul 3, 2023 | DISCN | 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 |
