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  1. pharmadog
  2. ›drugs
  3. ›Dyanavel XR
drug
save

amfetamine ER

Marketedupdated 3mo ago
by Tris Pharma Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 6
  • drugDYANAVEL XR 2028 co-mentions · 14 sources
  • drugDYANAVEL XR28 co-mentions · 14 sources
  • tagApproval28 co-mentions · 14 sources
  • drugamfetamine ER-ODT14 co-mentions · 14 sources
  • companyTris Pharma Inc14 co-mentions · 14 sources
  • tagSmall Molecule14 co-mentions · 14 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for attention deficit hyperactivity disorder and 3 investigational indications.

indications

investigational
Obesity

all catalysts(17)

approval · 17
Oct 19, 2015
approval
$TRAW
11y ago
DYANAVEL XR (AMPHETAMINE) — FDA approval
amfetamine ER
→
Jan 4, 2017
approval
$TRAW
10y ago
DYANAVEL XR (AMPHETAMINE) — FDA approval
amfetamine ER
→
May 12, 2017
approval
$TRAW
9y ago
DYANAVEL XR (AMPHETAMINE) — FDA approval
amfetamine ER
→
Feb 5, 2019
approval
$TRAW
8y ago
DYANAVEL XR (AMPHETAMINE) — FDA approval
amfetamine ER
→
Aug 5, 2019
approval
7y ago
AMPHETAMINE SULFATE — FDA approval
amfetamine ER
→
Oct 27, 2020
approval
6y ago
AMPHETAMINE SULFATE — FDA approval
amfetamine ER
→
Feb 10, 2022
approval
5y ago
AMPHETAMINE SULFATE — FDA approval
amfetamine ER
→
Feb 25, 2022
approval
$TRAW
4y ago
DYANAVEL XR (AMPHETAMINE) — FDA approval
amfetamine ER
→
Feb 25, 2022
approval
4y ago
AMPHETAMINE SULFATE — FDA approval
amfetamine ER
→
Feb 25, 2022
approval
4y ago
AMPHETAMINE SULFATE — FDA approval
amfetamine ER
→
Jun 1, 2022
approval
$TRAW
4y ago
DYANAVEL XR (AMPHETAMINE) — FDA approval
amfetamine ER
→
Oct 13, 2023
approval
3y ago
AMPHETAMINE SULFATE — FDA approval
amfetamine ER
→
Oct 13, 2023
approval
$TRAW
3y ago
DYANAVEL XR (AMPHETAMINE) — FDA approval
amfetamine ER
→
Oct 17, 2023
approval
3y ago
AMPHETAMINE SULFATE — FDA approval
amfetamine ER
→
Sep 23, 2025
approval
$TRAW
11mo ago
DYANAVEL XR (AMPHETAMINE) — FDA approval
amfetamine ER
→
Sep 26, 2025
approval
11mo ago
AMPHETAMINE SULFATE — FDA approval
amfetamine ER
→
Sep 26, 2025
approval
11mo ago
AMPHETAMINE SULFATE — FDA approval
amfetamine ER
→
view all 17 catalysts →

Patent cliff

source: FDA Orange Book
first barrier falls
Mar 15, 2027
216 days

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

patents (69)

  • Feb 11, 2040method-of-use (U-3538)US 12458592
  • Feb 11, 2040method-of-use (U-3538)US 12458592
  • Feb 11, 2040method-of-use (U-3538)US 12458592
  • Sep 24, 2038formulationUS 11590081
  • Sep 24, 2038formulationUS 11590081
  • Sep 24, 2038formulationUS 11590081
  • Mar 10, 2037formulationUS 10441554
  • Mar 10, 2037formulationUS 10441554
  • Mar 10, 2037formulationUS 10441554
  • Mar 10, 2037formulationUS 10441554
  • Mar 10, 2037formulationUS 10441554
  • Mar 10, 2037formulationUS 11160772
  • Mar 10, 2037formulationUS 11160772
  • Mar 10, 2037formulationUS 11160772
  • Mar 10, 2037formulationUS 11160772
  • Mar 10, 2037formulationUS 11160772
  • Mar 10, 2037method-of-use (U-3299)US 11896562
  • Mar 10, 2037method-of-use (U-3299)US 11896562
  • Mar 10, 2037method-of-use (U-3299)US 11896562
  • Mar 10, 2037method-of-use (U-3299)US 11896562
  • Sep 7, 2036formulationUS 11590228
  • Jun 28, 2032formulationUS 8709491
  • Jun 28, 2032formulationUS 8709491
  • Jun 28, 2032formulationUS 8709491
  • Jun 28, 2032formulationUS 8709491
  • Jun 28, 2032formulationUS 8709491
  • Jun 28, 2032formulationUS 8709491
  • Jun 28, 2032formulationUS 8709491
  • Jun 28, 2032formulationUS 9017731
  • Jun 28, 2032formulationUS 9017731
  • Jun 28, 2032formulationUS 9017731
  • Jun 28, 2032formulationUS 9017731
  • Jun 28, 2032formulationUS 9017731
  • Jun 28, 2032formulationUS 9017731
  • Jun 28, 2032formulationUS 9017731
  • Jun 28, 2032formulationUS 9265737
  • Jun 28, 2032formulationUS 9265737
  • Jun 28, 2032formulationUS 9265737
  • Jun 28, 2032formulationUS 9265737
  • Jun 28, 2032formulationUS 9265737
  • Jun 28, 2032formulationUS 9265737
  • Jun 28, 2032formulationUS 9265737
  • Jun 28, 2032formulationUS 9839619
  • Jun 28, 2032formulationUS 9839619
  • Jun 28, 2032formulationUS 9839619
  • Jun 28, 2032formulationUS 9839619
  • Jun 28, 2032formulationUS 9839619
  • Jun 28, 2032formulationUS 9839619
  • Mar 29, 2029formulationUS 80626672.6y
  • Mar 15, 2027formulationUS 10086087216d
  • Mar 15, 2027formulationUS 8337890216d
  • Mar 15, 2027formulationUS 8337890216d
  • Mar 15, 2027formulationUS 8337890216d
  • Mar 15, 2027formulationUS 8597684216d
  • Mar 15, 2027formulationUS 8747902216d
  • Mar 15, 2027formulationUS 8747902216d
  • Mar 15, 2027formulationUS 8747902216d
  • Mar 15, 2027formulationUS 8747902216d
  • Mar 15, 2027formulationUS 8883217216d
  • Mar 15, 2027formulationUS 9675703216d
  • Mar 15, 2027formulationUS 9675704216d
  • Mar 15, 2027formulationUS 9675704216d
  • Mar 15, 2027formulationUS 9675704216d
  • Apr 9, 2026formulationUS 8840924
  • Apr 9, 2026formulationUS 8840924
  • Apr 9, 2026formulationUS 8840924
  • Apr 9, 2026formulationUS 8840924
  • Apr 9, 2026formulationUS 8840924
  • Apr 9, 2026formulationUS 8840924

News(0)

no news has mentioned this drug yet

brand
Dyanavel XR
generic
amfetamine [INN]
MOA
12.1 Mechanism of Action Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known.
indication
Attention Deficit Hyperactivity Disorder (ADHD)
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 55m ago
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