REQUIP XL Drug Patent Profile
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When do Requip Xl patents expire, and when can generic versions of Requip Xl launch?
Requip Xl is a drug marketed by Glaxosmithkline Llc and is included in one NDA.
The generic ingredient in REQUIP XL is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Requip Xl
A generic version of REQUIP XL was approved as ropinirole hydrochloride by PRINSTON INC on May 5th, 2008.
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Summary for REQUIP XL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 136 |
| Clinical Trials: | 36 |
| Patent Applications: | 1,647 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for REQUIP XL |
| DailyMed Link: | REQUIP XL at DailyMed |
Recent Clinical Trials for REQUIP XL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Titan Pharmaceuticals | Phase 1/Phase 2 |
| Vanderbilt University Medical Center | Phase 4 |
| Seoul National University Hospital | Phase 4 |
Paragraph IV (Patent) Challenges for REQUIP XL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| REQUIP XL | Extended-release Tablets | ropinirole hydrochloride | 6 mg | 022008 | 1 | 2009-07-14 |
| REQUIP XL | Extended-release Tablets | ropinirole hydrochloride | 12 mg | 022008 | 1 | 2009-02-05 |
| REQUIP XL | Extended-release Tablets | ropinirole hydrochloride | 3 mg | 022008 | 1 | 2009-01-08 |
| REQUIP XL | Extended-release Tablets | ropinirole hydrochloride | 8 mg | 022008 | 1 | 2008-11-03 |
| REQUIP XL | Extended-release Tablets | ropinirole hydrochloride | 4 mg | 022008 | 1 | 2008-10-31 |
| REQUIP XL | Extended-release Tablets | ropinirole hydrochloride | 2 mg | 022008 | 1 | 2008-10-14 |
US Patents and Regulatory Information for REQUIP XL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-001 | Jun 13, 2008 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-006 | Apr 10, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-002 | Jun 13, 2008 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for REQUIP XL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-006 | Apr 10, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-002 | Jun 13, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-002 | Jun 13, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for REQUIP XL
See the table below for patents covering REQUIP XL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2031393 | COMPRIMES A LIBERATION PROGRESSIVE DE SUBSTANCES ACTIVES (TABLETS WITH CONTROLLED-RATE RELEASE OF ACTIVE SUBSTANCES) | ⤷ Sign Up |
| Germany | 60134964 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 0178688 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for REQUIP XL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0299602 | 97C0036 | Belgium | ⤷ Sign Up | PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702 |
| 0299602 | SPC/GB96/040 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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.
ISSN: 2162-2639
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