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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-seven suppliers are listed for this compound. Additional details are available on the topiramate profile page.
DrugPatentWatch® 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.
Summary for QUDEXY XR
| International Patents: | 11 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,201 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for QUDEXY XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QUDEXY XR |
| DailyMed Link: | QUDEXY XR at DailyMed |
Recent Clinical Trials for QUDEXY XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Upsher-Smith Laboratories | Phase 4 |
Pharmacology for QUDEXY XR
| Mechanism of Action | Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
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 | AB2 | RX | Yes | No | Get Started for $10 | Get Started for $10 | Get Started for $10 | |||
| Upsher Smith Labs | QUDEXY XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122-004 | Mar 11, 2014 | AB2 | RX | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | ||
| Upsher Smith Labs | QUDEXY XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122-005 | Mar 11, 2014 | AB2 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for QUDEXY XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20200010608 | Get Started for $10 |
| South Korea | 20160124930 | Get Started for $10 |
| Israel | 241053 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for QUDEXY XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0138441 | SPC/GB95/028 | United Kingdom | Get Started for $10 | PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
