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TROKENDI XR Drug Profile

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Trokendi Xr is a drug marketed by Supernus Pharms and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has eleven patent family members in eight countries.

The generic ingredient in TROKENDI XR is topiramate. There are twenty-six drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the topiramate profile page.

Summary for Tradename: TROKENDI XR

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Supernus Pharms
TROKENDI XR
topiramate
CAPSULE, EXTENDED RELEASE;ORAL201635-001Aug 16, 2013RXNo8,889,191► subscribe ► subscribe
Supernus Pharms
TROKENDI XR
topiramate
CAPSULE, EXTENDED RELEASE;ORAL201635-003Aug 16, 2013RXNo8,992,989► subscribeY ► subscribe
Supernus Pharms
TROKENDI XR
topiramate
CAPSULE, EXTENDED RELEASE;ORAL201635-004Aug 16, 2013RXYes8,992,989► subscribeY ► subscribe
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Paragraph IV activity for: TROKENDI XR

Drugname Dosage Strength RLD Submissiondate
topiramateExtended-release Capsules200 mgTrokendi XR4/3/2014
topiramateExtended-release Capsules25 mg, 50 mg, and 100 mgTrokendi XR5/12/2014

International Patent Family for Tradename: TROKENDI XR

Country Document Number Estimated Expiration
European Patent Office2394643► subscribe
Spain2312308► subscribe
European Patent Office1973528► 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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Supplementary Protection Certificates for Tradename: TROKENDI XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB95/028United Kingdom► subscribePRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718
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