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FLO-PRED

NDA

PREDNISOLONE ACETATE | N022067 | SUN PHARMA CANADA INC

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

Today

7799331

Oct. 11, 2028

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs2 inactive

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

EUROAPI FRANCEPREDNISOLONE ACETATE

DMF 35291979

HENAN LIHUA PHARMACEUTICAL CO LTDPREDNISOLONE ACETATE USP

DMF 285182014

SYMBIOTEC PHARMALAB PRIVATE LTDPREDNISOLONE ACETATE USP

DMF 327282018

DIOSYNTH BVInactivePREDNISOLONE ACETATE MICRO

DMF 39491980

PFIZER INCInactivePREDNISOLONE ACETATE USP,MICRO & NON MICRO

DMF 55041984

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2024	SUPPL -15	View Letter (PDF)
Jul 19, 2021	SUPPL -14	View Letter (PDF)
Jun 17, 2011	SUPPL -7	View Letter (PDF)
May 12, 2010	SUPPL -4	View Letter (PDF)
Oct 8, 2008	SUPPL -2	View Letter (PDF)
Jul 1, 2008	SUPPL -1	View Letter (PDF)
Jan 23, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 5MG BASE/5ML

2 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Jan 17, 2008

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7799331	Oct 11, 2028	—	—	Yes		—
7799331	Oct 11, 2028	—	—	Yes		—

#002 — EQ 15MG BASE/5ML

2 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: Jan 17, 2008