REQUIP Drug Patent Profile
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Which patents cover Requip, and what generic alternatives are available?
Requip is a drug marketed by Glaxosmithkline Llc and is included in two NDAs.
The generic ingredient in REQUIP is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Requip
A generic version of REQUIP was approved as ropinirole hydrochloride by PRINSTON INC on May 5th, 2008.
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Questions you can ask:
- What is the 5 year forecast for REQUIP?
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Summary for REQUIP
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 136 |
| Clinical Trials: | 36 |
| Patent Applications: | 1,647 |
| Drug Prices: | Drug price information for REQUIP |
| What excipients (inactive ingredients) are in REQUIP? | REQUIP excipients list |
| DailyMed Link: | REQUIP at DailyMed |
Recent Clinical Trials for REQUIP
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
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| REQUIP | Tablets | ropinirole hydrochloride | 3 mg, 4 mg and 5 mg | 020658 | 1 | 2005-02-04 |
| REQUIP | Tablets | ropinirole hydrochloride | 0.25 mg, 0.5 mg, 1 mg and 2 mg | 020658 | 1 | 2004-12-22 |
US Patents and Regulatory Information for REQUIP
| 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 | ropinirole hydrochloride | TABLET;ORAL | 020658-001 | Sep 19, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-005 | Sep 19, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-004 | Sep 19, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline Llc | REQUIP XL | ropinirole hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022008-004 | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-005 | Sep 19, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-007 | Jan 27, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-001 | Sep 19, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline Llc | REQUIP | ropinirole hydrochloride | TABLET;ORAL | 020658-002 | Sep 19, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for REQUIP
See the table below for patents covering REQUIP around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Portugal | 87542 | PROCESSO DE PREPARACAO DE UM MEDICAMENTO A BASE DE DERIVADOS DA INDOLONA PARA O TRATAMENTO DA DOENCA DE PARKINSON | ⤷ Sign Up |
| Philippines | 22067 | 4-AMINOALKYL-2(3H)-INDOLES | ⤷ Sign Up |
| New Zealand | 206344 | 4-OMEGA-INOALKYLINDOL-2(3H)-ONES AND PHARMACEUTICAL COMPOSITIONS | ⤷ Sign Up |
| Denmark | 169609 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for REQUIP
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0113964 | 97C0037 | Belgium | ⤷ Sign Up | PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826 |
| 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 |
| 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 |
| 0113964 | SPC/GB96/039 | United Kingdom | ⤷ Sign Up | SPC/GB96/039: 20031130, EXPIRES: 20081129 |
| >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.
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