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REQUIP XL Drug Profile

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Requip Xl is a drug marketed by Glaxosmithkline Llc and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and seven Paragraph IV challenges.

This drug has forty-five 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. Thirty-five suppliers are listed for this compound. Additional details are available on the ropinirole hydrochloride profile page.

Summary for Tradename: REQUIP XL

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: REQUIP XL

Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-001Jun 13, 2008RXYes7,927,624► subscribeY ► subscribe
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-006Apr 10, 2009RXNo7,927,624► subscribeY ► subscribe
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-002Jun 13, 2008DISCNNo8,303,986► subscribeY ► subscribe
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Expired Patents for Tradename: REQUIP XL

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-004Jun 13, 20085,422,123► subscribe
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-001Jun 13, 20085,422,123► subscribe
Glaxosmithkline Llc
REQUIP XL
ropinirole hydrochloride
TABLET, EXTENDED RELEASE;ORAL022008-005Oct 31, 20085,422,123► subscribe
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Paragraph IV activity 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
Slovenia1272167► subscribe
Czech Republic20023415► subscribe
Brazil0110038► 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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