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Generated: March 20, 2019

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NUCYNTA Drug Profile

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Which patents cover Nucynta, and when can generic versions of Nucynta launch?

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.

This drug has seventy-seven patent family members in thirty-three countries.

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 hydrochloride
(-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol
(R,R)-Tapentadol
175591-09-0
175591-23-8
3-((1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl) phenol hydrochloride
3-((1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl)-phenol hydrochloride
3-((1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl)phenol
3-((1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl)phenol hydrochloride
3-((2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl)phenol
3-((2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl)phenol hydrochloride
3-(1-DIMETHYLAMINO-2-METHYL-PENTAN-3-YL)PHENOL
3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methyl-propyl]phenol
3-[(1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl]phenol hdrochloride
3-[(1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl]phenol Hydrochloride
3-[(1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride
3-[(2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl]phenol
3-[(2R,3R)-1-dimethylamino-2-methylpentan-3-yl]phenol
4084AH
591T238
71204KII53
AB1008538
AB1008539
ACN-050883
AJ-08434
AK-43468
AKOS015951190
AN-3500
AX8210956
B-1798
BCP9000118
BDBM50386381
BN 200
BN 200 (BASE)
BN-200
CG 5503
CG-5503
CG5503
CG5503 (BASE)
CHEBI:135935
CHEMBL1201776
CHEMBL1201777
CS-0879
CS-M0020
D06007
D10199
DB06204
DEA No. 9780
DTXSID30170003
EBD2202137
FT-0674809
FT-0699883
GTPL7477
H8A007M585
HSDB 8309
HY-70042A
JNS-024 ER
KB-79930
KB-80810
KS-00000OJT
KWTWDQCKEHXFFR-SMDDNHRTSA-N
MFCD00944992
Nucynta (TN)
Nucynta ER
Palexia
Palexia retard
Palexia SR
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]-, hydrochloride
Phenol,3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-
QC-1146
R-331333
RL02248
SB17333
SB17334
SCHEMBL116924
SCHEMBL238138
ST24049325
Tapentadol
Tapentadol (hydrochloride)
Tapentadol (USAN/INN)
Tapentadol [USAN:INN]
Tapentadol HCl
Tapentadol hydrochloride
Tapentadol hydrochloride (JAN)
Tapentadol hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Tydol|||Zyntap|||3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-phenol hydrochloride
UNII-71204KII53
UNII-H8A007M585
W-5241
X4992
ZELFLGGRLLOERW-YECZQDJWSA-N
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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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
Depomed Inc NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 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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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 ➤ Try a Free Trial
➤ Subscribe Tablets x50 mg, 75 mg, and 100 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for NUCYNTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693475 CR 2010 00036 Denmark ➤ Try a Free Trial PRODUCT NAME: TAPENTADOL ((1R-2R)-3-(3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL)-PHENOL), HERUNDER HYDROCHLORIDET; NAT. REG. NO/DATE: 45151-45158, 45162-45169 20100830; FIRST REG. NO/DATE: EU 75043.00.00-75048.00.00, 75261.00.00-75270.00.00 20100819
0693475 SPC/GB11/031 United Kingdom ➤ Try a Free Trial PRODUCT NAME: TAPENTADOL IN THE FORM OF ITS BASE OR A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY THE HYDROCHLORIDE SALT.; REGISTERED: DE 75043 20100819; UK PL 21727/0032 - 0050 20110204
0693475 C00693475/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
0693475 2011/010 Ireland ➤ Try a Free Trial 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
0693475 91793 Luxembourg ➤ Try a Free Trial 91793, EXPIRES: 20200712
0693475 CA 2010 00036 Denmark ➤ Try a Free Trial
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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