GABAPENTIN | N022544 | ALMATICA PHARMA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
DEPOMED, INC. v. ACTAVIS ELIZABETH LLC et al 6 patentsANDA 203611, 203625, 203643gabapentin | D.N.J. | 2012-03-02 | Terminated 2014-08-19 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services,Inc. FDA-2026-P-2258 · 7 docket documents Lachman Consulting Services, Inc., on behalf of a client, filed this suitability petition pursuant to Section 505(j)(2)(C) of the FD&C Act requesting that the FDA declare Gabapentin Powder for Oral Solution in 300 mg/sachet, 400 mg/sachet, and 600 mg/sachet strengths suitable for submission as an AN | Suitability | 2026-03-04 | Open | Lachman Consulting Services,Inc. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-0685 · 6 docket documents Hyman, Phelps & McNamara, P.C. filed this suitability petition under FDC Act Section 505(j)(2)(C) and 21 C.F.R. § 314.93 requesting that FDA declare Gabapentin Tablets, 300 mg, suitable for submission as an ANDA referencing Viatris Specialty LLC's NEURONTIN (gabapentin) Tablets approved under NDA 02 | Suitability | 2026-01-22 | Open | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from Public Citizen’s Health Research Group FDA-2022-P-0149 · 9 docket documents Public Citizen submitted this petition on February 9, 2022, under Section 201 of the Controlled Substances Act and FDA regulations requesting that the DEA and FDA initiate proceedings to schedule gabapentin (brand names Neurontin and Gralise) and gabapentin enacarbil (brand name Horizant) into Sched | Other | 2022-02-10 | Denied | Public Citizen’s Health Research Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$15.30
per ea
Lowest NADAC/Unit
$10.14
per ea
Brand NDCs
5
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 52427089060GRALISE ER 900 MG TABLET | $15.30 | EA | Brand | — | 2026-06-17 |
| 52427085060GRALISE ER 750 MG TABLET | $15.19 | EA | Brand | — | 2025-09-17 |
| 52427080390GRALISE ER 300 MG TABLET | $10.19 | EA | Brand | $1.05 | 2026-06-17 |
| 52427080690GRALISE ER 600 MG TABLET | $10.16 | EA | Brand | $0.9984 | 2026-06-17 |
| 52427080460GRALISE ER 450 MG TABLET | $10.14 | EA | Brand | — | 2025-12-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.