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QUDEXY XR Drug Profile

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Qudexy Xr is a drug marketed by Upsher-smith Labs and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has five patent family members in five countries.

The generic ingredient in QUDEXY 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: QUDEXY XR

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher-smith Labs
QUDEXY XR
topiramate
CAPSULE, EXTENDED RELEASE;ORAL205122-001Mar 11, 2014RXNo8,889,190► subscribeY ► subscribe
Upsher-smith Labs
QUDEXY XR
topiramate
CAPSULE, EXTENDED RELEASE;ORAL205122-003Mar 11, 2014RXNo8,889,190► subscribeY ► subscribe
Upsher-smith Labs
QUDEXY XR
topiramate
CAPSULE, EXTENDED RELEASE;ORAL205122-002Mar 11, 2014RXNo9,101,545► subscribeY ► subscribe
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Paragraph IV activity for: QUDEXY XR

Drugname Dosage Strength RLD Submissiondate
topiramateExtended-release Capsules25 mg, 50 mg, 100 mg, 150 mg, and 200 mgQudexy XR12/24/2015

International Patent Family for Tradename: QUDEXY XR

Country Document Number Estimated Expiration
European Patent Office2968177► subscribe
Israel241053► subscribe
Canada2905011► 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: QUDEXY 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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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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