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GUANFACINE HYDROCHLORIDE

ANDA

GUANFACINE HYDROCHLORIDE | A202578 | PHARMOBEDIENT CONSULTING LLC

4 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Shire LLC et al v. Mylan Pharmaceuticals Inc. et al 1:2011cv00055 2 patentsANDA 202578guanfacine hydrochloride	WVND	2011-04-20	Terminated 2013-03-27	—

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

API Supply Chain7 active DMFs1 inactive

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

MEDICHEM SAGUANFACINE HYDROCHLORIDE

DMF 85901990

QUIMICA SINTETICA SAGUANFACINE HYDROCHLORIDE

DMF 86611990

JUBILANT PHARMOVA LTDGUANFACINE HYDROCHLORIDE USP

DMF 280492014

PROCOS SPAGUANFACINE HYDROCHLORIDE

DMF 283122014

TORRENT PHARMACEUTICALS LTDGUANFACINE HYDROCHLORIDE USP

DMF 284432014

UNICHEM LABORATORIES LTDGUANFACINE HYDROCHLORIDE USP

DMF 346532020

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 4, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

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#001 — EQ 1MG BASE

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 2, 2015

No patent or exclusivity listings for this strength.

#002 — EQ 2MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 2, 2015

#003 — EQ 3MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 2, 2015

#004 — EQ 4MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 2, 2015