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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
Accenture
Chubb
Mallinckrodt
Colorcon
Federal Trade Commission
US Department of Justice
Queensland Health

Generated: November 16, 2018

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NUCYNTA Drug Profile

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Which patents cover Nucynta, and what generic alternatives are available?

Nucynta is a drug marketed by Depomed Inc and Depo Nf and is included in three NDAs. There are seven patents protecting this drug and four Paragraph IV challenges.

The generic ingredient in NUCYNTA is tapentadol hydrochloride. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.

Drug patent expirations by year for NUCYNTA
Pharmacology for NUCYNTA
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Synonyms for NUCYNTA
(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol
(R,R)-Tapentadol
175591-23-8
3-((1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl)phenol
3-((2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl)phenol
3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methyl-propyl]phenol
3-[(2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl]phenol
3-[(2R,3R)-1-dimethylamino-2-methylpentan-3-yl]phenol
4084AH
AB1008538
ACN-050883
AJ-08434
AKOS015951190
AN-3500
B-1798
BCP9000118
BDBM50386381
BN 200
BN 200 (BASE)
BN-200
CG 5503
CG-5503
CG5503
CG5503 (BASE)
CHEBI:135935
CHEMBL1201776
CS-M0020
D06007
D0K4MH
DB06204
DEA No. 9780
DTXSID30170003
FT-0699883
GTPL7477
H8A007M585
HSDB 8309
KB-79930
KWTWDQCKEHXFFR-SMDDNHRTSA-N
Nucynta ER
Palexia
Phenol, 3-((1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-
phenol, 3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-
Phenol,3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-
QC-1146
RL02248
SCHEMBL116924
Tapentadol
Tapentadol (USAN/INN)
Tapentadol [USAN:INN]
UNII-H8A007M585
ZINC20783

US Patents and Regulatory Information for NUCYNTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for NUCYNTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008 ➤ Sign Up ➤ Sign Up
Depomed Inc NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012 ➤ Sign Up ➤ Sign Up
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008 ➤ Sign Up ➤ Sign Up
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for NUCYNTA
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets x50 mg, 75 mg, and 100 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe ➤ Sign Up
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for NUCYNTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693475/01 Switzerland ➤ Sign Up PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
90004-0.L Sweden ➤ Sign Up PRODUCT NAME: TAPENTADOL; NAT. REG. NO/DATE: 42622-42628 20100910; FIRST REG.: DE 7543-7548,7661-76270" EESGODKLANDKOD="DE" EESGODKDATUM="2010-08-19" SEGODKNR="42622-42628 20100819
11/010 Ireland ➤ Sign Up PRODUCT NAME: TAPENTADOL IN BASIC FORM OR IN THE FORM OF A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY TAPENTADOL HYDROCHLORIDE; NAT REGISTRATION NO/DATE: PA1189/007/001-008 20101221; FIRST REGISTRATION NO/DATE: PA1189/008/001-008 21/12/2010 GERMANY 75043.00.00 75044.00.00 75045.00.00 19/08/2010 GERMANY 76261.00.00 76262.00.00 76263.00.00 76264.00.00 76265.00.00 19/08/2010 GERMANY 75046.00.00 75047.00.00 75048.00.00 19/08/2010 GERMANY 76266.00.00 76267.00.00 76268.00.0076269.00.00 76270.00.00 20100819
C0016 France ➤ Sign Up PRODUCT NAME: TAPENTADOL SOUS FORME DE SA BASE LIBRE OU SOUS FORME D'UN DE SES SELS D'ACIDES ACCEPTABLES DU POINT DE VUE PHYSIOLOGIQUE; NAT. REGISTRATION NO/DATE: NL40884 20111003; FIRST REGISTRATION: DE - 76261.00.00 20100819
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
Accenture
Chubb
Mallinckrodt
Colorcon
Federal Trade Commission
US Department of Justice
Queensland 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.