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RYZOLT Drug Profile

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Ryzolt is a drug marketed by Purdue Pharma and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eighty patent family members in twenty-nine countries.

The generic ingredient in RYZOLT is tramadol hydrochloride. There are thirty-five drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

Summary for Tradename: RYZOLT

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

Pharmacology for Tradename: RYZOLT

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: RYZOLT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 2008DISCNNo7,988,998Oct 27, 2023Y
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 2008DISCNNo6,607,748Jun 29, 2020Y
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 2008DISCNNo6,607,748Jun 29, 2020Y
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Expired Patents for Tradename: RYZOLT

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 20085,591,452<disabled>
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-003Dec 30, 20085,591,452<disabled>
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 20086,254,887<disabled>
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Paragraph IV activity for: RYZOLT

Drugname Dosage Strength RLD Submissiondate
tramadol hydrochlorideExtended-release Tablets100 mg, 200 mg and 300 mgRyzolt6/18/2009

Non-Orange Book Patents for Tradename: RYZOLT

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
2,009,047,345<disabled in preview>
8,487,002Controlled-release compositions<disabled in preview>
2,010,151,022<disabled in preview>
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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: RYZOLT

Country Document Number Estimated Expiration
Brazil0315659<disabled in preview>
Brazil0112140<disabled in preview>
Argentina029549<disabled in preview>
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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: RYZOLT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00152Netherlands<disabled>PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
C/GB04/012United Kingdom<disabled>PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
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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 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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