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REQUIP XL Drug 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. There are two patents protecting this drug and seven Paragraph IV challenges.
This drug has fifty-one patent family members in twenty-seven countries.
The generic ingredient in REQUIP XL is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-two 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 MYLAN on May 5th, 2008.
Summary for REQUIP XL
| International Patents: | 51 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 116 |
| Clinical Trials: | 35 |
| Patent Applications: | 1,272 |
| 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 | NDA | Submissiondate |
|---|---|---|---|---|
| REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2009-07-14 |
| REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2009-02-05 |
| REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2009-01-08 |
| REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2008-11-03 |
| REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 2008-10-31 |
| REQUIP XL | TABLET, EXTENDED RELEASE;ORAL | ropinirole hydrochloride | 022008 | 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 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-005 | Oct 31, 2008 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-003 | Jun 13, 2008 | DISCN | 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 |
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 | 022008-003 | Jun 13, 2008 | Start Trial | Start Trial |
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-001 | Jun 13, 2008 | Start Trial | Start Trial |
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-005 | Oct 31, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for REQUIP XL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 101158968 | Start Trial |
| European Patent Office | 0432607 | Start Trial |
| Italy | MI20001963 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for REQUIP XL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0299602 | SPC/GB96/040 | United Kingdom | Start Trial | PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702 |
| 0299602 | 97C0036 | Belgium | Start Trial | PRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
