Viewing data from:

FLUOCINONIDE

ANDA

FLUOCINONIDE | A208989 | ZYDUS LIFESCIENCES LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: VANOS(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
MEDICIS PHARMACEUTICAL CORPORATION et al v. ZYDUS PHARMACEUTICALS (USA) INC. et al 1:2016cv01565 4 patentsANDA 208989fluocinonide	D.N.J.	2016-03-21	Terminated 2017-01-05	—

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

API Supply Chain3 active DMFs5 inactive

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

TAPI NL BVFLUOCINONIDE

DMF 45911982

TARO PHARMACEUTICAL INDUSTRIES LTDFLUOCINONIDE USP MICRONIZED

DMF 141511999

TAPI NL BVFLUOCINONIDE (NEW PROCESS)

DMF 212612008

ANTIBIOTICOS SPAInactiveFLUOCINONIDE (BULK, NON STERILE, NON-MICRONIZED & MICRONIZED)

DMF 31121978

CESQUISA SAInactiveFLUOCINONIDE

DMF 73841988

FARMABOISInactiveFLUOCINONIDE

DMF 73911988

QUATRUMInactiveFLUOCINONIDE

DMF 74321988

NOBEL CHEMICALS AB DIV FINE CHEMICALS INCInactiveFLUOCINONIDE

DMF 75031988

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

Products (1)

#001 — 0.1%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Feb 10, 2020

No patent or exclusivity listings for this strength.