Viewing data from:

GUANFACINE HYDROCHLORIDE

ANDA

GUANFACINE HYDROCHLORIDE | A205430 | APOTEX INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: INTUNIV(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Shire LLC et al v. Apotex, Inc. et al 1:2013cv01965 2 patentsANDA 205430Guanfacine Hydrochloride	D. Del.	2013-11-21	Terminated 2014-04-07	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$0.1861

per ea

Lowest NADAC/Unit

$0.1441

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
60505393001GUANFACINE HCL ER 4 MG TABLET	$0.1861	EA	Generic	—	2026-06-17
60505392801GUANFACINE HCL ER 2 MG TABLET	$0.1764	EA	Generic	—	2026-06-17
60505392901GUANFACINE HCL ER 3 MG TABLET	$0.1713	EA	Generic	—	2026-06-17
60505392701GUANFACINE HCL ER 1 MG TABLET	$0.1441	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$23.20

Highest Price

$23.20

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
60505-3927-01GUANFACINE 1MG 24HR TAB,SA	$23.20	FSS	The Davinci Company, LLC	06/30/2029
60505-3928-01GUANFACINE 2MG 24HR TAB,SA	$23.20	FSS	The Davinci Company, LLC	06/30/2029
60505-3929-01GUANFACINE 3MG 24HR TAB,SA	$23.20	FSS	The Davinci Company, LLC	06/30/2029
60505-3930-01GUANFACINE 4MG 24HR TAB,SA	$23.20	FSS	The Davinci Company, LLC	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain8 active DMFs1 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

MEDICHEM SAGUANFACINE HYDROCHLORIDE

DMF 85901990

QUIMICA SINTETICA SAGUANFACINE HYDROCHLORIDE

DMF 86611990

JUBILANT BIOSYS LTDGUANFACINE HYDROCHLORIDE USP

DMF 280492014

PROCOS SPAGUANFACINE HYDROCHLORIDE

DMF 283122014

TORRENT PHARMACEUTICALS LTDGUANFACINE HYDROCHLORIDE USP

DMF 284432014

UNICHEM LABORATORIES LTDGUANFACINE HYDROCHLORIDE USP

DMF 346532020

PHARMABLOCK PHARMACEUTICALS (ZHEJIANG) CO LTDGUANFACINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE

DMF 364312021

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDGUANFACINE HYDROCHLORIDE

DMF 394042024

SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INCInactiveGUANFACINE HYDROCHLORIDE

DMF 49851983

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (4)

Sort:

#001 — EQ 1MG BASE

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 25, 2018

No patent or exclusivity listings for this strength.

#002 — EQ 2MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 25, 2018

#003 — EQ 3MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 25, 2018

#004 — EQ 4MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 25, 2018