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Last Updated: October 20, 2019

DrugPatentWatch Database Preview

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 Assertio 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-nine 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. Five suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.

Drug patent expirations by year for NUCYNTA
Drug Prices for NUCYNTA

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Recent Clinical Trials for NUCYNTA

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SponsorPhase
GrĂ¼nenthal GmbHPhase 4
Ortho-McNeil Janssen Scientific Affairs, LLCPhase 3
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Phase 3

See all NUCYNTA clinical trials

Recent Litigation for NUCYNTA

Identify potential future generic entrants

District Court Litigation
Case NameDate
GRUNENTHAL GMBH v. ROXANE LABORATIORES, INC.2014-06-19
Celltrion Healthcare Co., Ltd. v. Janssen Biotech, Inc.2014-03-31
GRUNENTHAL GMBH v. ALKEM LABORATORIES LIMITED2013-12-23

See all NUCYNTA litigation

PTAB Litigation
PetitionerDate
Rosellini Scientific, LLC2016-01-15

See all NUCYNTA litigation

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   Start Trial   Start Trial Y   Start Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 RX Yes No   Start Trial   Start Trial   Start Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NUCYNTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008   Start Trial   Start Trial
Assertio NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012   Start Trial   Start Trial
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008   Start Trial   Start Trial
Depo Nf NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for NUCYNTA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets x50 mg, 75 mg, and 100 mg ➤ Subscribe   Start Trial
➤ Subscribe Extended-release Tablets 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg ➤ Subscribe   Start Trial
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe   Start Trial
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe   Start Trial

Supplementary Protection Certificates for NUCYNTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693475 12C0016 France   Start Trial 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
0693475 CR 2010 00036 Denmark   Start 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 CA 2010 00036 Denmark   Start Trial
0693475 PA2011007 Lithuania   Start Trial PRODUCT NAME: TAPENTADOLUM; NAT. REGISTRATION NO/DATE: LT/1/10/2341/001 - LT/1/10/2341/66, 2011 02 19; LT/1/10/2342/001 - LT/1/10/2342/110 20110219; FIRST REGISTRATION: 75043.00.00 - 75048.00.00, 2010 08 19; 76261.00.00 - 76270.00.00 20100819
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Colorcon

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