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Last Updated: April 4, 2020

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NUCYNTA ER Drug Profile


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

Nucynta Er is a drug marketed by Depo Nf and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seventy-five patent family members in thirty-seven countries.

The generic ingredient in NUCYNTA ER 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 Er

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

There have been twenty-seven 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 ER
Drug Prices for NUCYNTA ER

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Recent Clinical Trials for NUCYNTA ER

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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 ER clinical trials

Recent Litigation for NUCYNTA ER

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharma L.P. v. Ascent Pharmaceuticals, Inc.2018-01-11
Purdue Pharma L.P. v. Kashiv Pharma, LLC2018-01-03
Purdue Pharma L.P. v. Amneal Pharmaceuticals, LLC2018-01-03

See all NUCYNTA ER litigation

PTAB Litigation
PetitionerDate
2016-01-15

See all NUCYNTA ER litigation

Pharmacology for NUCYNTA ER
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Synonyms for NUCYNTA ER
(-)-(1r,2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride
(-)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
175591-09-0
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 hydrochloride
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-[1-(Dimethylamino)-2-methylpentan-3-yl]phenol--hydrogen chloride (1/1)
591T238
71204KII53
AB1008539
AK-43468
AKOS016842888
AX8210956
BN-200 HYDROCHLORIDE
CG-5503 HYDROCHLORIDE
CG5503 HYDROCHLORIDE
CHEMBL1201777
CS-0879
D10199
DTXSID00938677
EBD2202137
FT-0674809
HY-70042A
JNS-024 ER
KS-00000OJT
MFCD00944992
Nucynta
Nucynta (TN)
Palexia retard
Palexia SR
Phenol, 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-, hydrochloride
Q27265914
R-331333
SB17334
SCHEMBL238138
ST24049325
Tapentadol (hydrochloride)
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
W-5241
X4992
ZELFLGGRLLOERW-YECZQDJWSA-N
Paragraph IV (Patent) Challenges for NUCYNTA ER
Tradename Dosage Ingredient NDA Submissiondate
NUCYNTA ER TABLET, EXTENDED RELEASE;ORAL tapentadol hydrochloride 200533 2012-11-20

US Patents and Regulatory Information for NUCYNTA ER

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 200533-005 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
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
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 RX Yes No   Start Trial   Start Trial Y 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 ER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011   Start Trial   Start Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011   Start Trial   Start Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011   Start Trial   Start Trial
Depo Nf NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NUCYNTA ER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0693475 91793 Luxembourg   Start Trial 91793, EXPIRES: 20200712
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 C00693475/01 Switzerland   Start Trial PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Baxter
AstraZeneca
Dow
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.