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EPIOXA HD/EPIOXA KIT

NDA

RIBOFLAVIN 5'-PHOSPHATE SODIUM | N219910 | GLAUKOS CORP

1 strength0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

2027

2028

Today

Oct. 17, 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.

SIEGFRIED GRAFTON INCRIBOFLAVIN 5'-PHOSPHATE SODIUM

DMF 271882013

TIANJIN PHARMACEUTICAL HOLDINGS GENCOM PHARMACY CO LTDRIBOFLAVIN 5'-PHOSPHATE SODIUM

DMF 299232015

SHANXI JIXIANG BIOLOGICAL ENGINEERING CO LTDRIBOFLAVIN 5'-PHOSPHATE SODIUM

DMF 412442025

HOFFMANN LA ROCHE INCInactiveRIBOFLAVIN 5'-PHOSPHATE SODIUM

DMF 65821986

BASF CO LTDInactiveRIBOFLAVIN (BULK DRUG SUBSTANCE)

DMF 188462005

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 21, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.239% BASE/ML;EQ 0.177% BASE/ML

RLD

0 patents1 exclusivity▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Oct 17, 2025

Code	Date	Status
NP	Oct 17, 2028	Active