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Last Updated: August 6, 2020

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QUDEXY XR Drug Profile

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When do Qudexy Xr patents expire, and what generic alternatives are available?

Qudexy Xr is a drug marketed by Upsher Smith Labs and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has eleven patent family members in six countries.

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

US ANDA Litigation and Generic Entry Outlook for Qudexy Xr

A generic version of QUDEXY XR was approved as topiramate by ACCORD HLTHCARE on March 27th, 2009.

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Paragraph IV (Patent) Challenges for QUDEXY XR
Tradename Dosage Ingredient NDA Submissiondate
QUDEXY XR CAPSULE, EXTENDED RELEASE;ORAL topiramate 205122 2015-12-24

US Patents and Regulatory Information for QUDEXY XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-001 Mar 11, 2014 BC RX Yes No   Start Trial   Start Trial   Start Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-004 Mar 11, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-005 Mar 11, 2014 BC RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-002 Mar 11, 2014 BC RX Yes No   Start Trial   Start Trial Y   Start Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-001 Mar 11, 2014 BC RX Yes No   Start Trial   Start Trial Y   Start Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-003 Mar 11, 2014 BC RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
Moodys
Johnson and Johnson
Mallinckrodt
Boehringer Ingelheim

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