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  1. pharmadog
  2. ›drugs
  3. ›Nucynta ER
drug
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tapentadol hydrochloride ER

Marketedupdated 5mo ago
by $COLL COLLEGIUM PHARMACEUTICAL, INC
Approved
community read0 votes

🐶 often sniffed alongside

top 6
  • tagApproval158 co-mentions · 59 sources
  • drugNUCYNTA155 co-mentions · 59 sources
  • drugNUCYNTA ER155 co-mentions · 59 sources
  • tagSmall Molecule79 co-mentions · 59 sources
  • drugTAPENTADOL HYDROCHLORIDE79 co-mentions · 59 sources
  • companyNovitium Pharma LLC1 co-mentions · 1 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for 4 indications.

all catalysts(58)

approval · 58
Nov 20, 2008
approval
$COLL22.02+0.82%
18y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Nov 9, 2009
approval
$COLL22.02+0.82%
17y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Nov 1, 2010
approval
$COLL22.02+0.82%
16y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Nov 1, 2010
approval
$COLL22.02+0.82%
16y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Aug 25, 2011
approval
$COLL22.02+0.82%
15y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jul 9, 2012
approval
$COLL22.02+0.82%
14y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Aug 28, 2012
approval
$COLL22.02+0.82%
14y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Oct 15, 2012
approval
$COLL22.02+0.82%
14y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Apr 15, 2013
approval
$COLL22.02+0.82%
13y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jul 11, 2013
approval
$COLL22.02+0.82%
13y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jul 11, 2013
approval
$COLL22.02+0.82%
13y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jul 11, 2013
approval
$COLL22.02+0.82%
13y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jul 11, 2013
approval
$COLL22.02+0.82%
13y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jul 11, 2013
approval
$COLL22.02+0.82%
13y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Oct 31, 2013
approval
$COLL22.02+0.82%
13y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Oct 31, 2013
approval
$COLL22.02+0.82%
13y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jan 16, 2014
approval
$COLL22.02+0.82%
13y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jan 16, 2014
approval
$COLL22.02+0.82%
13y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jan 16, 2014
approval
$COLL22.02+0.82%
13y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Apr 16, 2014
approval
$COLL22.02+0.82%
12y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Aug 19, 2014
approval
$COLL22.02+0.82%
12y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Nov 17, 2014
approval
$COLL22.02+0.82%
12y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Nov 17, 2014
approval
$COLL22.02+0.82%
12y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jun 26, 2015
approval
$COLL22.02+0.82%
11y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Apr 20, 2016
approval
$COLL22.02+0.82%
10y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Sep 30, 2016
approval
$COLL22.02+0.82%
10y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Dec 16, 2016
approval
$COLL22.02+0.82%
10y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Dec 16, 2016
approval
$COLL22.02+0.82%
10y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Dec 16, 2016
approval
$COLL22.02+0.82%
10y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
May 26, 2017
approval
$COLL22.02+0.82%
9y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Sep 18, 2018
approval
$COLL22.02+0.82%
8y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Sep 18, 2018
approval
$COLL22.02+0.82%
8y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Sep 18, 2018
approval
$COLL22.02+0.82%
8y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Sep 18, 2018
approval
$COLL22.02+0.82%
8y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Sep 18, 2018
approval
$COLL22.02+0.82%
8y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Sep 18, 2018
approval
$COLL22.02+0.82%
8y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Oct 7, 2019
approval
$COLL22.02+0.82%
7y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Oct 7, 2019
approval
$COLL22.02+0.82%
7y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Oct 7, 2019
approval
$COLL22.02+0.82%
7y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Mar 4, 2021
approval
$COLL22.02+0.82%
6y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Mar 4, 2021
approval
$COLL22.02+0.82%
6y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Mar 4, 2021
approval
$COLL22.02+0.82%
6y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jul 3, 2023
approval
$COLL22.02+0.82%
3y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jul 3, 2023
approval
$COLL22.02+0.82%
3y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Dec 15, 2023
approval
$COLL22.02+0.82%
3y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Dec 15, 2023
approval
$COLL22.02+0.82%
3y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Dec 15, 2023
approval
$COLL22.02+0.82%
3y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jun 14, 2024
approval
$COLL22.02+0.82%
2y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jun 14, 2024
approval
$COLL22.02+0.82%
2y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jun 14, 2024
approval
$COLL22.02+0.82%
2y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Oct 31, 2024
approval
$COLL22.02+0.82%
2y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Oct 31, 2024
approval
$COLL22.02+0.82%
2y ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Oct 31, 2024
approval
$COLL22.02+0.82%
2y ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Dec 22, 2025
approval
$COLL22.02+0.82%
10mo ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Dec 22, 2025
approval
$COLL22.02+0.82%
10mo ago
NUCYNTA (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Dec 22, 2025
approval
$COLL22.02+0.82%
10mo ago
NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) — FDA approval
tapentadol hydrochloride ER
→
Jan 26, 2026
approval
8mo ago
TAPENTADOL HYDROCHLORIDE — FDA approval
tapentadol hydrochloride ER
→
Feb 10, 2026
approval
8mo ago
TAPENTADOL HYDROCHLORIDE — FDA approval
tapentadol hydrochloride ER
→
view all 58 catalysts →

Patent cliff

source: FDA Orange Book
first barrier falls
Jan 3, 2027
91 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (20)

  • Mar 22, 2029patentUS 8536130*PED2.5y
  • Mar 22, 2029patentUS 8536130*PED2.5y
  • Mar 22, 2029patentUS 8536130*PED2.5y
  • Mar 22, 2029patentUS 8536130*PED2.5y
  • Mar 22, 2029patentUS 8536130*PED2.5y
  • Oct 21, 2028patentUS 11344512*PED2.0y
  • Oct 21, 2028patentUS 11344512*PED2.0y
  • Oct 21, 2028patentUS 11344512*PED2.0y
  • Oct 21, 2028patentUS 11344512*PED2.0y
  • Oct 21, 2028patentUS 11344512*PED2.0y
  • Sep 22, 2028method-of-use (U-1276)US 85361302.0y
  • Sep 22, 2028method-of-use (U-1276)US 85361302.0y
  • Sep 22, 2028method-of-use (U-1276)US 85361302.0y
  • Sep 22, 2028method-of-use (U-1276)US 85361302.0y
  • Sep 22, 2028method-of-use (U-1276)US 85361302.0y
  • Apr 21, 2028method-of-use (U-3391)US 113445121.5y
  • Apr 21, 2028method-of-use (U-3392)US 113445121.5y
  • Apr 21, 2028method-of-use (U-3391)US 113445121.5y
  • Apr 21, 2028method-of-use (U-3391)US 113445121.5y
  • Apr 21, 2028method-of-use (U-3391)US 113445121.5y

FDA exclusivities (8)

  • Jan 3, 2027PEDPediatric (6mo bonus)91d
  • Jan 3, 2027PEDPediatric (6mo bonus)91d
  • Jan 3, 2027PEDPediatric (6mo bonus)91d
  • Jan 3, 2027PEDPediatric (6mo bonus)91d
  • Jul 3, 2026NPPNew Product (3y)
  • Jul 3, 2026NPPNew Product (3y)
  • Jul 3, 2026NPPNew Product (3y)
  • Jul 3, 2026NPPNew Product (3y)

News(0)

no news has mentioned this drug yet

brand
Nucynta ER
generic
tapentadol hydrochloride
MOA
12.1 Mechanism of Action Tapentadol is a centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that tapentadol is a mu-opioid receptor (MOR) agonist and a norepinephrine reuptake inhibitor (NRI). Analgesia in animal models is derived from both of these properties.
indication
Diabetic Neuropathic Pain
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 4h ago
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