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Serving hundreds of leading biopharmaceutical companies globally:

Merck
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Generated: August 17, 2018

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 Depomed Inc 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
Generic Entry Opportunity Date for NUCYNTA
Generic Entry Dates for NUCYNTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;ORAL
Generic Entry Dates for NUCYNTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NUCYNTA
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Synonyms for NUCYNTA
(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol
(R,R)-Tapentadol
175591-23-8
3-((1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl)phenol
3-((2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl)phenol
3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methyl-propyl]phenol
3-[(2R,3R)-1-(dimethylamino)-2-methylpentan-3-yl]phenol
3-[(2R,3R)-1-dimethylamino-2-methylpentan-3-yl]phenol
4084AH
AB1008538
ACN-050883
AJ-08434
AKOS015951190
AN-3500
B-1798
BCP9000118
BDBM50386381
BN 200
BN 200 (BASE)
BN-200
CG 5503
CG-5503
CG5503
CG5503 (BASE)
CHEBI:135935
CHEMBL1201776
CS-M0020
D06007
D0K4MH
DB06204
DEA No. 9780
DTXSID30170003
FT-0699883
GTPL7477
H8A007M585
HSDB 8309
KB-79930
KWTWDQCKEHXFFR-SMDDNHRTSA-N
Nucynta ER
Palexia
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]-
QC-1146
RL02248
SCHEMBL116924
Tapentadol
Tapentadol (USAN/INN)
Tapentadol [USAN:INN]
UNII-H8A007M585
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
Depomed Inc 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
Depomed Inc 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 Y ➤ Try a Free Trial
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Depomed Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y 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
Depomed Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Depomed Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Depomed Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 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 Tablets x50 mg, 75 mg, and 100 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Tablets 50 mg, 100 mg, 150 mg, 200 mg, and 250 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

Non-Orange Book US Patents for NUCYNTA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,248,737 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects ➤ Try a Free Trial
6,344,558 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effect ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for NUCYNTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/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
00541 Netherlands ➤ Try a Free 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
2010 00036 Denmark ➤ Try a Free Trial
90004-0.L Sweden ➤ Try a Free 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
2011007 Lithuania ➤ Try a Free 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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Colorcon
Harvard Business School
Merck
Chubb
Federal Trade Commission
Citi
Cantor Fitzgerald
Johnson and Johnson

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