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Serving leading biopharmaceutical companies globally:

Fish and Richardson
UBS
QuintilesIMS
Queensland Health
Boehringer Ingelheim
Baxter
Colorcon
Farmers Insurance
Federal Trade Commission
Medtronic

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022304

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NDA 022304 describes NUCYNTA, which is a drug marketed by Depomed Inc and is included in three NDAs. It is available from six suppliers. There are seven patents protecting this drug and four Paragraph IV challenges. Additional details are available on the NUCYNTA profile page.

The generic ingredient in NUCYNTA is tapentadol hydrochloride. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
Summary for 022304
Tradename:NUCYNTA
Applicant:Depomed Inc
Ingredient:tapentadol hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022304
Mechanism of ActionOpioid Agonists
Suppliers and Packaging for NDA: 022304
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304 NDA Rebel Distributors Corp 21695-069 E 21695-069-72
NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304 NDA Lake Erie Medical DBA Quality Care Products LLC 35356-525 N 35356-525-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Nov 20, 2008TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN
Patent:➤ Try a Free TrialPatent Expiration:Aug 5, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Nov 20, 2008TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN

Expired US Patents for NDA 022304

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depomed Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Depomed Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Depomed Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Colorcon
Medtronic
Daiichi Sankyo
Fuji
McKinsey
Deloitte
Covington
Harvard Business School

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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