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  2. ›drugs
  3. ›PREGABALIN
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PREGABALIN

Marketedupdated 3mo ago
by RK Pharma Inc
Approved
annual revenue · 2024–2024peak $383M
2024: $383M2024$383M
community read0 votes

🐶 often sniffed alongside

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  • tagSmall Molecule29 co-mentions · 29 sources
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  • companyLupin Ltd3 co-mentions · 3 sources
  • companyStrides Pharma Inc3 co-mentions · 3 sources

all catalysts(14)

approval · 14
Apr 13, 2021
approval
5y ago
PREGABALIN — FDA approval
PREGABALIN
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Apr 13, 2021
approval
5y ago
PREGABALIN — FDA approval
PREGABALIN
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Mar 8, 2022
approval
4y ago
PREGABALIN — FDA approval
PREGABALIN
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May 3, 2022
approval
4y ago
PREGABALIN — FDA approval
PREGABALIN
→
Apr 26, 2023
approval
3y ago
PREGABALIN — FDA approval
PREGABALIN
→
Jul 21, 2023
approval
3y ago
PREGABALIN — FDA approval
PREGABALIN
→
May 30, 2024
approval
2y ago
PREGABALIN — FDA approval
PREGABALIN
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Dec 9, 2024
approval
2y ago
PREGABALIN — FDA approval
PREGABALIN
→
Sep 30, 2025
approval
11mo ago
PREGABALIN — FDA approval
PREGABALIN
→
Feb 2, 2026
approval
6mo ago
PREGABALIN — FDA approval
PREGABALIN
→
Feb 3, 2026
approval
6mo ago
PREGABALIN — FDA approval
PREGABALIN
→
Feb 23, 2026
approval
6mo ago
PREGABALIN — FDA approval
PREGABALIN
→
Feb 23, 2026
approval
6mo ago
PREGABALIN — FDA approval
PREGABALIN
→
Mar 30, 2026
approval
5mo ago
PREGABALIN — FDA approval
PREGABALIN
→
view all 14 catalysts →

Trials studying PREGABALIN

  • phase1Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in U.S. Healthy Participantsnot yet recruitingn=11
  • phase2Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathyrecruitingn=300
  • phase1A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Painrecruitingn=168
  • phase2Y-4 to Treat the Postherpetic Neuralgiarecruitingn=160
  • phase3Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathyrecruitingn=1,100
  • —A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweatsactive not recruitingn=999
  • phase2Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)completedn=194
  • EP1Pharmacodynamic Study of 300mg Pregabalin vs Placebo in Healthy Male Adultscompletedn=20
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 2, 2026
79 days

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

patents (18)

  • May 2, 2027patentUS 10022447*PED260d
  • May 2, 2027patentUS 10022447*PED260d
  • May 2, 2027patentUS 10022447*PED260d
  • May 2, 2027patentUS 8945620*PED260d
  • May 2, 2027patentUS 8945620*PED260d
  • May 2, 2027patentUS 8945620*PED260d
  • May 2, 2027patentUS 9144559*PED260d
  • May 2, 2027patentUS 9144559*PED260d
  • May 2, 2027patentUS 9144559*PED260d
  • Nov 2, 2026method-of-use (U-2136)US 1002244779d
  • Nov 2, 2026method-of-use (U-2136)US 1002244779d
  • Nov 2, 2026method-of-use (U-2136)US 1002244779d
  • Nov 2, 2026formulationUS 894562079d
  • Nov 2, 2026formulationUS 894562079d
  • Nov 2, 2026formulationUS 894562079d
  • Nov 2, 2026formulationUS 914455979d
  • Nov 2, 2026formulationUS 914455979d
  • Nov 2, 2026formulationUS 914455979d

News(0)

no news has mentioned this drug yet

brand
PREGABALIN
generic
PREGABALIN
indication
Diabetic Peripheral Neuropathy
phase
marketed
approved
2004-12-30
Data sources
openFDA · ClinicalTrials.gov
last refreshed 26m ago
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