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Last Updated: November 28, 2021

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TEGRETOL-XR Drug Patent Profile


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Which patents cover Tegretol-xr, and when can generic versions of Tegretol-xr launch?

Tegretol-xr is a drug marketed by Novartis and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Tegretol-xr

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

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Drug patent expirations by year for TEGRETOL-XR
Drug Prices for TEGRETOL-XR

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Drug Sales Revenue Trends for TEGRETOL-XR

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Recent Clinical Trials for TEGRETOL-XR

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

SponsorPhase
University Health Network, TorontoEarly Phase 1
Center for Clinical Pharmacology Research Bdbeq S.A.Phase 1
IRCCS National Neurological Institute "C. Mondino" FoundationPhase 4

See all TEGRETOL-XR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TEGRETOL-XR
Paragraph IV (Patent) Challenges for TEGRETOL-XR
Tradename Dosage Ingredient NDA Submissiondate
TEGRETOL-XR TABLET, EXTENDED RELEASE;ORAL carbamazepine 020234 2005-12-30

US Patents and Regulatory Information for TEGRETOL-XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-001 Mar 25, 1996 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-002 Mar 25, 1996 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-003 Mar 25, 1996 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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-XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-001 Mar 25, 1996 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-002 Mar 25, 1996 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-003 Mar 25, 1996 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-003 Mar 25, 1996 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-002 Mar 25, 1996 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-001 Mar 25, 1996 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TEGRETOL-XR

Country Patent Number Estimated Expiration
Italy 8748270 ⤷  Free Forever Trial
Australia 7661787 ⤷  Free Forever Trial
United Kingdom 2193632 ⤷  Free Forever Trial
German Democratic Republic 285718 ⤷  Free Forever Trial
Philippines 25090 ⤷  Free Forever Trial
Australia 597403 ⤷  Free Forever Trial
Hong Kong 33793 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

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