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Serving leading biopharmaceutical companies globally:

Citi
Novartis
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US Department of Justice
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Mallinckrodt
Cerilliant
Merck
Farmers Insurance
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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021745

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NDA 021745 describes RYZOLT, which 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. Additional details are available on the RYZOLT profile page.

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

Summary for 021745

Tradename:1
Applicant:1
Ingredient:1
Patents:2
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 021745

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 30, 2008TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jun 29, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Oct 27, 2023Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 30, 2008TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jun 29, 2020Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021745

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue PharmaRYZOLTtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 2008► Subscribe► Subscribe
Purdue PharmaRYZOLTtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021745-003Dec 30, 2008► Subscribe► Subscribe
Purdue PharmaRYZOLTtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 2008► Subscribe► Subscribe
Purdue PharmaRYZOLTtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021745-003Dec 30, 2008► Subscribe► Subscribe
Purdue PharmaRYZOLTtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021745-002Dec 30, 2008► Subscribe► Subscribe
Purdue PharmaRYZOLTtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL021745-001Dec 30, 2008► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Medtronic
Cipla
Harvard Business School
Accenture
Federal Trade Commission
McKinsey
Cantor Fitzgerald
Julphar
Fish and Richardson
Argus Health

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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