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Generated: June 24, 2017
What is the patent landscape for Qudexy Xr, and when can generic versions of Qudexy Xr launch?
Qudexy Xr is a drug marketed by Upsher-smith Labs and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.| Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 52 |
| Patent Applications: see list | 5,406 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | QUDEXY XR at DailyMed |
| Mechanism of Action | Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
| 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 | RX | Yes | No | 9,555,005 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Upsher-smith Labs | QUDEXY XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122-005 | Mar 11, 2014 | RX | Yes | Yes | 8,652,527 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Upsher-smith Labs | QUDEXY XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122-002 | Mar 11, 2014 | RX | Yes | No | 8,652,527 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Upsher-smith Labs | QUDEXY XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122-001 | Mar 11, 2014 | RX | Yes | No | 8,889,190 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Upsher-smith Labs | QUDEXY XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122-003 | Mar 11, 2014 | RX | Yes | No | 8,889,190 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| topiramate | Extended-release Capsules | 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg | Qudexy XR | 12/24/2015 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| South Korea | 20160124930 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 241053 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 101674509 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2968177 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2905011 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB95/028 | United Kingdom | ► Subscribe | PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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