Viewing data from:

TENEX

NDA

GUANFACINE HYDROCHLORIDE | N019032 | PROMIUS PHARMA LLC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Unichem Pharmaceuticals (USA) Inc. FDA-2020-P-0813 Unichem Pharmaceuticals (USA) Inc. filed this citizen petition on February 13, 2020, requesting that the FDA Commissioner determine whether the Reference Listed Drug TENEX (Guanfacine Hydrochloride) Tablets, 1 mg and 2 mg (NDA 019032), held by Promius Pharma LLC, has been voluntarily withdrawn from	505(q)	2020-03-12	Denied	Unichem Pharmaceuticals (USA) Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

3 letters from Drugs@FDA

Date	Submission	Document
Jul 5, 2013	SUPPL -21	View Letter (PDF)
Mar 12, 2002	SUPPL -16	View Letter (PDF)
Mar 12, 2002	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 27, 1986

No patent or exclusivity listings for this strength.

#002 — EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 7, 1988

#003 — EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 7, 1988