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. Forty-four 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.
Summary for TEGRETOL-XR


See drug prices for TEGRETOL-XR

Recent Clinical Trials for TEGRETOL-XR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dr Cipto Mangunkusumo General Hospital | Phase 4 |
Dhaka Medical College | Phase 4 |
Janssen Pharmaceutica N.V., Belgium | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for TEGRETOL-XR
Paragraph IV (Patent) Challenges for TEGRETOL-XR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TEGRETOL-XR | Extended-release Tablets | carbamazepine | 100 mg | 020234 | 1 | 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-002 | Mar 25, 1996 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-003 | Mar 25, 1996 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 | See Plans and Pricing | See Plans and Pricing |
Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-003 | Mar 25, 1996 | See Plans and Pricing | See Plans and Pricing |
Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-003 | Mar 25, 1996 | See Plans and Pricing | See Plans and Pricing |
Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-002 | Mar 25, 1996 | See Plans and Pricing | See Plans and Pricing |
Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-001 | Mar 25, 1996 | See Plans and Pricing | See Plans and Pricing |
Novartis | TEGRETOL-XR | carbamazepine | TABLET, EXTENDED RELEASE;ORAL | 020234-002 | Mar 25, 1996 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TEGRETOL-XR
See the table below for patents covering TEGRETOL-XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Netherlands | 194780 | See Plans and Pricing | |
United Kingdom | 2193632 | ORAL SUSTAINED RELEASE FORMS OF CARBAMAZEPINE | See Plans and Pricing |
Finland | 86143 | See Plans and Pricing | |
Norway | 173726 | See Plans and Pricing | |
Portugal | 85489 | PROCESSO PARA A PREPARACAO DE UM SISTEMA TEREPEUTICO ORAL TENDO ACCAO SISTEMICA | See Plans and Pricing |
Japan | S6344525 | ORAL THERAPEUTICAL SYSTEM HAVING GENERAL ACTIVITY AND MANUFACTURE | See Plans and Pricing |
Denmark | 410787 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |