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Last Updated: August 3, 2020

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TEGRETOL Drug Profile

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When do Tegretol patents expire, and what generic alternatives are available?

Tegretol is a drug marketed by Novartis and is included in four NDAs.

The generic ingredient in TEGRETOL is carbamazepine. There are twenty-seven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

US ANDA Litigation and Generic Entry Outlook for Tegretol

A generic version of TEGRETOL was approved as carbamazepine by TARO on October 3rd, 1996.

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Drug patent expirations by year for TEGRETOL
Drug Prices for TEGRETOL

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Drug Sales Revenue Trends for TEGRETOL

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Recent Clinical Trials for TEGRETOL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Center for Clinical Pharmacology Research Bdbeq S.A.Phase 1
IRCCS National Neurological Institute "C. Mondino" FoundationPhase 4
Yonsei UniversityPhase 4

See all TEGRETOL clinical trials

US Patents and Regulatory Information for TEGRETOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TEGRETOL carbamazepine SUSPENSION;ORAL 018927-001 Dec 18, 1987 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-001 Mar 25, 1996 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis TEGRETOL carbamazepine TABLET, CHEWABLE;ORAL 018281-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis TEGRETOL carbamazepine TABLET;ORAL 016608-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-003 Mar 25, 1996 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 TEGRETOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TEGRETOL carbamazepine SUSPENSION;ORAL 018927-001 Dec 18, 1987   Start Trial   Start Trial
Novartis TEGRETOL carbamazepine TABLET;ORAL 016608-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Novartis TEGRETOL carbamazepine TABLET, CHEWABLE;ORAL 018281-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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