Qudexy XR Drug Patent Profile
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Which patents cover 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 five patents protecting this drug and one Paragraph IV challenge.
This drug has ten 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. Fifty-one 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: | 10 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 103 |
Clinical Trials: | 1 |
Patent Applications: | 5,077 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for Qudexy XR |
Drug Sales Revenues: | Drug sales revenues 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 2C19 Inhibitors Cytochrome P450 3A4 Inducers |
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for Qudexy XR
Paragraph IV (Patent) Challenges for QUDEXY XR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
QUDEXY XR | Extended-release Capsules | topiramate | 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg | 205122 | 1 | 2015-12-24 |
US Patents and Regulatory Information for Qudexy XR
Qudexy XR is protected by five US patents.
Patents protecting Qudexy XR
Extended-release topiramate capsules
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SEIZURES
Extended-release topiramate capsules
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Extended-release topiramate capsules
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Extended-release topiramate capsules
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Extended-release topiramate capsules
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Upsher Smith Labs | QUDEXY XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122-004 | Mar 11, 2014 | AB2 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Upsher Smith Labs | QUDEXY XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122-005 | Mar 11, 2014 | AB2 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Upsher Smith Labs | QUDEXY XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122-002 | Mar 11, 2014 | AB2 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Upsher Smith Labs | QUDEXY XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122-001 | Mar 11, 2014 | AB2 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Upsher Smith Labs | QUDEXY XR | topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 205122-003 | Mar 11, 2014 | AB2 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
>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
See the table below for patents covering Qudexy XR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 112015022434 | cápsulas de topiramato de liberação estendida | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2014143380 | ⤷ Try a Trial | |
Israel | 241053 | קפסולות של טופיראמאט עם שחרור מושהה (Extended-release topiramate capsules) | ⤷ Try a Trial |
South Korea | 20200010608 | 서방성 토피라메이트 캡슐 (EXTENDED-RELEASE TOPIRAMATE CAPSULES) | ⤷ Try a Trial |
South Korea | 102072618 | ⤷ Try a Trial | |
South Korea | 20160124930 | 서방성 토피라메이트 캡슐 (EXTENDED-RELEASE TOPIRAMATE CAPSULES) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >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 | ⤷ Try a Trial | PRODUCT NAME: TOPIRAMATE; REGISTERED: UK 0242/0301 19950718 |
2317997 | 2190050-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |