GUANFACINE HYDROCHLORIDE | N022037 | TAKEDA PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2013-11-21 | Terminated 2014-04-07 | — | |
Shire LLC et al v. Mylan Pharmaceuticals Inc. et al 2 patentsANDA 202578guanfacine hydrochloride | N.D. W. Va. | 2011-04-20 | Terminated 2013-03-27 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-7432 · 7 docket documents Hyman, Phelps & McNamara, P.C., on behalf of an unnamed client, submitted this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Guanfacine Extended-Release Powder for Oral Suspension, 1 mg/mL, suitable for submission as an Ab | Suitability | 2025-12-31 | Open | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$9.40
per ea
Lowest NADAC/Unit
$9.28
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 54092051302INTUNIV ER 1 MG TABLET | $9.40 | EA | Brand | $0.1441 | 2026-06-17 |
| 54092051702INTUNIV ER 3 MG TABLET | $9.30 | EA | Brand | $0.1713 | 2026-06-17 |
| 54092051902INTUNIV ER 4 MG TABLET | $9.30 | EA | Brand | $0.1861 | 2026-06-17 |
| 54092051502INTUNIV ER 2 MG TABLET | $9.28 | EA | Brand | $0.1764 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.