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NDA

FLAVOXATE HYDROCHLORIDE | N016769 | ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC

1 strength0 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 Chain2 active DMFs6 inactive

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

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAFLAVOXATE HYDROCHLORIDE

DMF 64941986

ISOCHEMFLAVOXATE HYDROCHLORIDE

DMF 90421991

LONZA INCInactiveFLAVOXATE HYDROCHLORIDE

DMF 44301982

SANKYO CHEMICAL INDUSTRIES INCInactiveFLAVOXATE HYDROCHLORIDE

DMF 68791987

SUMIKA FINE CHEMICALS CO LTDInactiveFLAVOXATE HYDROCHLORIDE

DMF 84431990

YAMAMOTO CHEMICAL INDUSTRIES CO LTDInactiveFLAVOXATE HYDROCHLORIDE JP XIII

DMF 131791998

SCINOPHARM TAIWAN LTDInactiveFLAVOXATE HYDROCHLORIDE

DMF 156132001

DAITO CORPInactiveFLAVOXATE HYDROCHLORIDE JP14

DMF 163362002

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

Products (1)

#001 — 100MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.