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Serving leading biopharmaceutical companies globally:

Chubb
Merck
US Department of Justice
Cipla
Farmers Insurance
Chinese Patent Office
QuintilesIMS
Fish and Richardson
McKinsey
Daiichi Sankyo

Generated: October 17, 2017

DrugPatentWatch Database Preview

RYZOLT Drug Profile

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What is the patent landscape for Ryzolt, and when can generic versions of Ryzolt launch?

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

This drug has eighty-nine patent family members in twenty-nine countries and two supplementary protection certificates in two countries.

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

Summary for Tradename: RYZOLT

US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list27
Patent Applications: see list1,245
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:RYZOLT at DailyMed

Pharmacology for Tradename: RYZOLT

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 2008DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 2008DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 2008DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 2008DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-003Dec 30, 2008DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-003Dec 30, 2008DISCNYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: RYZOLT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 2008► Subscribe► Subscribe
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 2008► Subscribe► Subscribe
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-003Dec 30, 2008► Subscribe► Subscribe
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 2008► Subscribe► Subscribe
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 2008► Subscribe► Subscribe
Purdue Pharma
RYZOLT
tramadol hydrochloride
TABLET, EXTENDED RELEASE;ORAL021745-003Dec 30, 2008► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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► Subscribe
8,487,002Controlled-release compositions► Subscribe
2,010,151,022► 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: RYZOLT

Country Document Number Estimated Expiration
TaiwanI319713► Subscribe
Russian Federation2005115883► Subscribe
Hungary0301302► Subscribe
Norway20026254► Subscribe
MexicoPA05004410► Subscribe
Denmark1305009► Subscribe
Spain2305567► Subscribe
Spain2310686► Subscribe
Brazil0315657► Subscribe
South Korea101120729► 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: RYZOLT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00152Netherlands► SubscribePRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
C/GB04/012United Kingdom► SubscribePRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Covington
Healthtrust
US Department of Justice
Teva
Johnson and Johnson
Dow
Merck
QuintilesIMS
Daiichi Sankyo
Deloitte

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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