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NDA

HALOBETASOL PROPIONATE | N208183 | LACER PHARMA LLC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

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2033

Today

8962028

Jun. 19, 2033

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
Sun Pharmaceutical Industries, Inc. et al v. Perrigo Company et al 1:2018cv00530 1 patentANDA 211464halobetasol propionate	MIWD	2018-05-10	Terminated 2018-08-24	—
Sun Pharmaceutical Industries, Inc. et al v. Perrigo Company et al 1:2018cv00703 1 patentANDA 211464halobetasol propionate	D. Del.	2018-05-09	Terminated 2020-03-11	—

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

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

2 letters from Drugs@FDA

Date	Submission	Document
Aug 28, 2020	SUPPL -2	View Letter (PDF)
Nov 13, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05%

RLD

1 patent0 exclusivities▴

LOTION;TOPICAL | Approved: Nov 6, 2015

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8962028	Jun 19, 2033	—	—	Yes		—