Viewing data from:

BRYHALI

NDA

HALOBETASOL PROPIONATE | N209355 | BAUSCH HEALTH AMERICAS INC

1 strength6 unique patents0 unique exclusivities

Patent Timeline

6 unique patents by expiration date

Active (6)Today

2027

2028

2029

2030

2031

2032

Today

Nov. 2, 2031

Nov. 2, 2031

Nov. 2, 2031

Nov. 2, 2031

Nov. 2, 2031

Nov. 2, 2031

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
BAUSCH HEALTH IRELAND LIMITED et al v. PADAGIS ISRAEL PHARMACEUTICALS LTD et al 2:2020cv05426 2 patentsANDA 214285halobetasol propionate	D.N.J.	2020-05-01	Terminated 2022-12-01	—
BAUSCH HEALTH IRELAND LIMITED et al v. GLENMARK PHARMACEUTICALS LIMITED 3:2019cv14502 1 patentANDA 213323halobetasol propionate	D.N.J.	2019-06-28	Terminated 2020-01-06	—

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 Bryhali (2023)

Total Spending

$142K

Total Claims

330

Beneficiaries

190

Avg Cost/Unit

$5.40

Spending Trend

$527K(2019)→$354K(2020)→$238K(2021)→$198K(2022)→$142K(2023)

YoY Change:+10.2%

5yr CAGR:+7.6%

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

API Supply Chain7 active DMFs2 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

WAVELENGTH ENTERPRISES LTDHALOBETASOL PROPIONATE

DMF 168562003

STERLING SPAHALOBETASOL PROPIONATE

DMF 168612003

HOVIONE FARMACIENCIA SAHALOBETASOL PROPIONATE

DMF 169532003

TARO PHARMACEUTICAL INDUSTRIES LTDHALOBETASOL PROPIONATE USP, MICRONIZED

DMF 175292004

TRIFARMA SPAHALOBETASOL PROPIONATE

DMF 185662005

SYMBIOTEC PHARMALAB PRIVATE LTDHALOBETASOL PROPIONATE

DMF 194022006

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDHALOBETASOL PROPIONATE

DMF 309062016

SAFC INCInactiveHALOBETASOL PROPIONATE (HBS)

DMF 163292002

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveHALOBETASOL PROPIONATE

DMF 169442003

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 15, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.01%

RLD

6 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Nov 6, 2018

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8809307	Nov 2, 2031	—	—	Yes	—	—
10478502	Nov 2, 2031	—	—	Yes		—
11839656	Nov 2, 2031	—	—	—		—
11957753	Nov 2, 2031	—	—	Yes	—	—
11986527	Nov 2, 2031	—	—	—		—
12076403	Nov 2, 2031	—	—	Yes	—	—