OXCARBAZEPINE - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for oxcarbazepine and what is the scope of freedom to operate?
Oxcarbazepine
is the generic ingredient in three branded drugs 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, Novartis, Ajanta Pharma Ltd, Apotex, Supernus Pharms, Ani Pharms, Annora Pharma, Breckenridge Pharm, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, and Zydus, and is included in twenty-eight NDAs. There are eleven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Oxcarbazepine has fourteen patent family members in ten countries.
There are twenty-one drug master file entries for oxcarbazepine. Thirty-five suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for OXCARBAZEPINE
International Patents: | 14 |
US Patents: | 11 |
Tradenames: | 3 |
Applicants: | 24 |
NDAs: | 28 |
Drug Master File Entries: | 21 |
Finished Product Suppliers / Packagers: | 35 |
Raw Ingredient (Bulk) Api Vendors: | 130 |
Clinical Trials: | 63 |
Patent Applications: | 6,220 |
Drug Prices: | Drug price trends 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 |
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 |
Generic filers with tentative approvals for OXCARBAZEPINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 600MG | TABLET, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 300MG | TABLET, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 150MG | TABLET, 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 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm Inds | OXCARBAZEPINE | oxcarbazepine | TABLET;ORAL | 077794-002 | Oct 9, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ajanta Pharma Ltd | OXCARBAZEPINE | oxcarbazepine | TABLET, EXTENDED RELEASE;ORAL | 217659-001 | Feb 22, 2024 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ajanta Pharma Ltd | OXCARBAZEPINE | oxcarbazepine | TABLET, EXTENDED RELEASE;ORAL | 217659-003 | Feb 22, 2024 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Supernus Pharms | OXTELLAR XR | oxcarbazepine | TABLET, EXTENDED RELEASE;ORAL | 202810-002 | Oct 19, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Supernus Pharms | OXTELLAR XR | oxcarbazepine | TABLET, EXTENDED RELEASE;ORAL | 202810-002 | Oct 19, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 OXCARBAZEPINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-002 | Jan 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | TRILEPTAL | oxcarbazepine | SUSPENSION;ORAL | 021285-001 | May 25, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-001 | Jan 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | TRILEPTAL | oxcarbazepine | SUSPENSION;ORAL | 021285-001 | May 25, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | TRILEPTAL | oxcarbazepine | TABLET;ORAL | 021014-003 | Jan 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for OXCARBAZEPINE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2396051 | ⤷ Sign Up | |
Japan | 2013079267 | CONTROLLED RELEASED PREPARATION OF OXCARBAZEPINE HAVING SIGMOIDAL RELEASE PROFILE | ⤷ Sign Up |
European Patent Office | 2026815 | PRÉPARATIONS À LIBÉRATION CONTRÔLÉE D'OXCARBAZÉPINE AYANT UN PROFIL DE LIBÉRATION SIGMOÏDE (CONTROLLED RELEASED PREPARATIONS OF OXCARBAZEPINE HAVING SIGMOIDAL RELEASE PROFILE) | ⤷ Sign Up |
European Patent Office | 2359830 | Préparations à libération contrôlée d'oxcarbazépine disposant d'un profil à libération sigmoïdale (Controlled released preparations of oxcarbazepine having sigmoidal release profile) | ⤷ Sign Up |
Spain | 2360423 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.