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TOPICORT

NDA

DESOXIMETASONE | N204141 | SUN PHARMA CANADA INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expired (1)Active (1)Today

2027

2028

Today

8277780

Sep. 1, 2028

8715624

May. 26, 2026

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
TARO PHARMACEUTICALS U.S.A., INC. et al v. GLENMARK PHARMACEUTICALS LTD. et al 2:2018cv12569 2 patentsANDA 211760desoximetasone	D.N.J.	2018-08-08	Terminated 2019-11-26	—

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 Chain5 active DMFs2 inactive

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

TARO PHARMACEUTICAL INDUSTRIES LTDDESOXIMETASONE USP

DMF 138611998

EUROAPI FRANCEDESOXIMETASONE USP, MICRONIZED

DMF 148522000

FARMABIOS SPADESOXIMETASONE

DMF 177592004

SYMBIOTEC PHARMALAB PRIVATE LTDDESOXIMETASONE USP (MICRONIZED)

DMF 224002009

TARO PHARMACEUTICAL INDUSTRIES LTDDESOXIMETASONE USP, MICRONIZED

DMF 268412013

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveDESOXIMETASONE

DMF 74241988

TARO PHARMACEUTICAL INDUSTRIES LTDInactiveDESOXIMETASONE

DMF 110181994

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Oct 12, 2021	SUPPL -9	View Letter (PDF)
Dec 17, 2015	SUPPL -4	View Letter (PDF)
Apr 16, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.25%

RLDAT

2 patents0 exclusivities▴

SPRAY;TOPICAL | Approved: Apr 11, 2013

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8277780	Sep 1, 2028	—	—	Yes		—
8715624	May 26, 2026	—	—	Yes		—