Viewing data from:

VANOS

NDA

FLUOCINONIDE | N021758 | BAUSCH HEALTH US LLC

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

2 cases 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	—
Medicis Pharmaceutical Corporation v. Nycomed US Inc. 1:2010cv01099 4 patentsANDA 20735Fluocinolide	D. Del.	2010-12-15	Terminated 2011-07-01	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Vanos (2023)

Total Spending

$26K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$29.23

Spending Trend

$679K(2019)→$628K(2020)→$205K(2021)→$57K(2022)→$26K(2023)

YoY Change:+2.3%

5yr CAGR:+3.0%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Mar 19, 2012	SUPPL -17	View Letter (PDF)
Nov 16, 2011	SUPPL -16	View Letter (PDF)
Jan 5, 2011	SUPPL -14	View Letter (PDF)
Mar 10, 2010	SUPPL -12	View Letter (PDF)
Dec 28, 2006	SUPPL -7	View Letter (PDF)
Mar 3, 2006	SUPPL -1	View Letter (PDF)
Nov 30, 2005	SUPPL -2	View Letter (PDF)
Feb 17, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

RLDAB

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Feb 11, 2005

No patent or exclusivity listings for this strength.