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Generated: December 17, 2017

DrugPatentWatch Database Preview

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 patent family members in twenty-seven countries and two supplementary protection certificates in two countries.

The generic ingredient in REQUIP XL is ropinirole hydrochloride. There are fourteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.
Drug patent expirations by year for REQUIP XL

Pharmacology for REQUIP XL

Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-001Jun 13, 2008ABRXYesYes► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-005Oct 31, 2008ABRXYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-003Jun 13, 2008ABRXYesNo► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-002Jun 13, 2008DISCNYesNo► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-006Apr 10, 2009ABRXYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-003Jun 13, 2008ABRXYesNo► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-005Oct 31, 2008ABRXYesNo► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-004Jun 13, 2008ABRXYesNo► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-001Jun 13, 2008ABRXYesYes► Subscribe► SubscribeY► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-001Jun 13, 2008ABRXYesYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: REQUIP XL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-003Jun 13, 2008► Subscribe► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-001Jun 13, 2008► Subscribe► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-004Jun 13, 2008► Subscribe► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-002Jun 13, 2008► Subscribe► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-006Apr 10, 2009► Subscribe► Subscribe
Glaxosmithkline LlcREQUIP XLropinirole hydrochlorideTABLET, EXTENDED RELEASE;ORAL022008-005Oct 31, 2008► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for REQUIP XL

Drugname Dosage Strength RLD Submissiondate
ropinirole hydrochloride*Extended-release Tablets3 mgRequip XL1/8/2009
ropinirole hydrochlorideExtended-release Tablets6 mgRequip XL7/22/2009
ropinirole hydrochlorideExtended-release Tablets12 mgRequip XL2/5/2009
ropinirole hydrochlorideExtended-release Tablets3 mgRequip XL1/8/2009
ropinirole hydrochlorideExtended-release Tablets8 mgRequip XL11/3/2008
ropinirole hydrochlorideExtended-release Tablets4 mgRequip XL10/31/2008
ropinirole hydrochloride Extended-release Tablets2 mgRequip XL10/14/2008

Non-Orange Book Patents for Tradename: REQUIP XL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,460,706Hydrophilic/lipophilic polymeric matrix dosage formulation► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: REQUIP XL

Country Document Number Estimated Expiration
Poland365837► Subscribe
South Korea20090094406► Subscribe
Japan2003530423► Subscribe
Italy1318470► Subscribe
Norway20024919► Subscribe
Israel152184► Subscribe
European Patent Office1272167► Subscribe
ItalyMI20000852► Subscribe
South Korea101158968► Subscribe
European Patent Office3175848► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: REQUIP XL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0036Belgium► SubscribePRODUCT NAME: CHLORHYDRATE DE ROPINIROLE (=ROPINIROLE); NAT. REGISTRATION NO/DATE: 981 IS 120 F 3 19970414; FIRST REGISTRATION: GB PL 10592/0085 19960702
C/GB96/040United Kingdom► SubscribePRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
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Serving leading biopharmaceutical companies globally:

Cerilliant
Colorcon
Teva
Dow
Fuji
McKesson
Johnson and Johnson
Federal Trade Commission
Fish and Richardson
AstraZeneca

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 verifification 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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