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WYTENSIN

NDA

GUANABENZ ACETATE | N018587 | WYETH AYERST LABORATORIES

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain0 active DMFs6 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

EVONIK TECHNOCHEMIE GMBHInactiveGUANABENZ ACETATE

DMF 57391985

HELSINN CHEMICALS SAInactiveGUANABENZ ACETATE

DMF 58971985

PROSINTEX INDUSTRIE CHIMIQUE ITALIANE SRLInactiveGUANABENZ ACETATE

DMF 78421988

CILAG CHEMIE AGInactiveGUANABENZ ACETATE

DMF 79571989

FINE CHEMICALS CORPInactiveGUANABENZ ACETATE

DMF 81871989

MEDICHEM SAInactiveGUANABENZ ACETATE

DMF 82911989

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

Products (3)

Sort:

#001 — EQ 4MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 7, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 8MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 7, 1982

#003 — EQ 16MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 7, 1982