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Last Updated: June 5, 2020

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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 Collegium Pharm Inc and is included in three NDAs. There are seven patents protecting this drug and four Paragraph IV challenges.

This drug has eighty-two patent family members in thirty-four 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.

US ANDA Litigation and Generic Entry Outlook for Nucynta

Nucynta was eligible for patent challenges on November 20, 2012.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (tapentadol hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for NUCYNTA
Drug Prices for NUCYNTA

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Recent Clinical Trials for NUCYNTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Grünenthal GmbHPhase 4
Ortho-McNeil Janssen Scientific Affairs, LLCPhase 3
Grünenthal GmbHPhase 3

See all NUCYNTA clinical trials

Recent Litigation for NUCYNTA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Celltrion Healthcare Co., Ltd. v. Janssen Biotech, Inc.2014-03-31
GRUNENTHAL GMBH v. ALKEM LABORATORIES LIMITED2013-12-23
Janssen Pharmaceuticals, Inc. v. Roxane Laboratories, Inc.2013-11-15

See all NUCYNTA litigation

PTAB Litigation
PetitionerDate
2016-01-15

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-[(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
3-[1-(Dimethylamino)-2-methylpentan-3-yl]phenol--hydrogen chloride (1/1)
3-[3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol
4084AH
591T238
71204KII53
AB1008538
AB1008539
ACN-050883
AK-43468
AKOS015951190
AKOS016842888
AR-270/43507984
AX8210956
B-1798
BCP9000118
BDBM50386381
BN 200
BN 200 (BASE)
BN-200
BN-200 HYDROCHLORIDE
CG 5503
CG-5503
CG-5503 HYDROCHLORIDE
CG5503
CG5503 (BASE)
CG5503 HYDROCHLORIDE
CG5503 IR
CHEBI:135935
CHEMBL1201776
CHEMBL1201777
CS-0879
CS-M0020
D06007
D10199
DB06204
DEA No. 9780
DTXSID00938677
DTXSID30170003
EBD2202137
FT-0674809
FT-0699883
GTPL7477
H8A007M585
HSDB 8309
HY-70042A
JNS-024 ER
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]-
Q27265914
Q414463
QC-1146
R-331333
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
Paragraph IV (Patent) Challenges for NUCYNTA
Tradename Dosage Ingredient NDA Submissiondate
NUCYNTA SOLUTION;ORAL tapentadol hydrochloride 203794 2013-12-20
NUCYNTA TABLET;ORAL tapentadol hydrochloride 022304 2012-11-20

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
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No   Start Trial   Start Trial Y   Start Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 RX Yes No   Start Trial   Start Trial   Start Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No   Start Trial   Start Trial   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
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008   Start Trial   Start Trial
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012   Start Trial   Start Trial
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008   Start Trial   Start Trial
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NUCYNTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693475 1190004-0.L Sweden   Start Trial 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
0693475 SPC/GB11/031 United Kingdom   Start 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 CA 2010 00036 Denmark   Start Trial
0693475 C300541 Netherlands   Start Trial PRODUCT NAME: TAPENTADOL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TAPENTADOL HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 110721-110724 RVG 110728-110731 20120316; FIRST REGISTRATION: DE 75043.00.00 - 75045.00.00, 75046.00.00, 76261.00.00 - 76270.00.00 20120819
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
AstraZeneca
Express Scripts
Johnson and Johnson
Merck

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 verification 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.