OXCARBAZEPINE - Generic Drug Details

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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, Kanchan Hlthcare, 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-six 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:	36
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

See drug prices for OXCARBAZEPINE

Drug Sales Revenue Trends for OXCARBAZEPINE

See drug sales revenues 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

See all OXCARBAZEPINE clinical trials

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

N03AF	Carboxamide derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Renew Pharms	OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	211420-001	Jul 9, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rubicon	OXCARBAZEPINE	oxcarbazepine	TABLET;ORAL	207717-003	Mar 5, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-003	Oct 19, 2012	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-003	Oct 19, 2012	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	OXCARBAZEPINE	oxcarbazepine	TABLET;ORAL	078005-002	Dec 11, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Kanchan Hlthcare	OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	217782-001	Feb 14, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-003	Oct 19, 2012	AB	RX	Yes	Yes	⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TRILEPTAL	oxcarbazepine	SUSPENSION;ORAL	021285-001	May 25, 2001	⤷ Sign Up	⤷ Sign Up
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-002	Jan 14, 2000	⤷ Sign Up	⤷ Sign Up
Novartis	TRILEPTAL	oxcarbazepine	TABLET;ORAL	021014-003	Jan 14, 2000	⤷ 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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for OXCARBAZEPINE

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Country	Patent Number	Title	Estimated Expiration
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
China	101489560	Controlled released preparations of oxcarbazepine having sigmoidal release profile	⤷ Sign Up
Germany	602007012236		⤷ Sign Up
Australia	2007242984	Controlled released preparations of oxcarbazepine having sigmoidal release profile	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007127630		⤷ Sign Up
Japan	2013079267	CONTROLLED RELEASED PREPARATION OF OXCARBAZEPINE HAVING SIGMOIDAL RELEASE PROFILE	⤷ Sign Up
Spain	2360423		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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