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Last Updated: October 22, 2019

DrugPatentWatch Database Preview

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

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

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Recent Litigation for NUCYNTA ER

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

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PTAB Litigation
PetitionerDate
Rosellini Scientific, LLC2016-01-15

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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
591T238
71204KII53
AB1008539
AK-43468
AX8210956
CHEMBL1201777
CS-0879
D10199
EBD2202137
FT-0674809
HY-70042A
JNS-024 ER
KB-80810
KS-00000OJT
MFCD00944992
Nucynta
Nucynta (TN)
Palexia retard
Palexia SR
Phenol, 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-, hydrochloride
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

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
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 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 200533-004 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 200533-003 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for NUCYNTA ER
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for NUCYNTA ER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0693475 2011/010 Ireland   Start 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 PA2011007,C0693475 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 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 91793 Luxembourg   Start Trial 91793, EXPIRES: 20200712
0693475 C00693475/01 Switzerland   Start Trial PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
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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