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CARBATROL Drug Profile

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Carbatrol is a drug marketed by Shire and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in nine countries.

The generic ingredient in CARBATROL is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the carbamazepine profile page.

Summary for Tradename: CARBATROL

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-003Sep 30, 1997RXNo5,912,013► subscribe ► subscribe
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-001Sep 30, 1997RXNo5,912,013► subscribe ► subscribe
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-002Sep 30, 1997RXYes5,912,013► subscribe ► subscribe
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Expired Patents for Tradename: CARBATROL

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-003Sep 30, 19975,326,570► subscribe
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-001Sep 30, 19975,912,013► subscribe
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-002Sep 30, 19975,912,013► subscribe
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Paragraph IV activity for: CARBATROL

Drugname Dosage Strength RLD Submissiondate
carbamazepineExtended-release Capsules100 mg and 200 mgCarbatrol2/2/2006

Non-Orange Book Patents for Tradename: CARBATROL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,326,570 Advanced drug delivery system and method of treating psychiatric, neurological and other disorders with carbamazepine► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: CARBATROL

Country Document Number Estimated Expiration
Spain2137948► subscribe
Greece3031448► subscribe
European Patent Office0660705► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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