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HYDELTRASOL

NDA

PREDNISOLONE SODIUM PHOSPHATE | N011028 | MERCK AND CO INC

1 strength0 unique patents0 unique exclusivities

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

2 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome NCT01624805	Phase 2	Recruiting	M.D. Anderson Cancer Center	140	2012-06-25 → 2029-06-30
IA Lidocaine and Methylprednisolone for Headache Associated With Subarachnoid Hemorrhage NCT07054801	Phase 2	Recruiting	Daniel Raper, MBBS	25	2026-06-23 → 2027-06-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Prednisolone Sodium Phosphate* (2023)

Total Spending

$1.0M

Total Claims

30,382

Beneficiaries

21,651

Avg Cost/Unit

$1.53

Spending Trend

$135K(2019)→$788K(2019)→$100K(2020)→$580K(2020)→$160K(2021)→$794K(2021)→$915K(2022)→$157K(2022)→$172K(2023)→$1.0M(2023)

YoY Change:-21.6%

5yr CAGR:-4.3%

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

API Supply Chain5 active DMFs5 inactive

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

EUROAPI FRANCEPREDNISOLONE SODIUM PHOSPHATE

DMF 40511981

CURIA SPAIN SAUPREDNISOLONE SODIUM PHOSPHATE

DMF 226242009

SYMBIOTEC PHARMALAB PRIVATE LTDPREDNISOLONE SODIUM PHOSPHATE USP

DMF 238992010

HENAN LIHUA PHARMACEUTICAL CO LTDPREDNISOLONE SODIUM PHOSPHATE USP

DMF 297512015

FARMABIOS SPAPREDNISOLONE SODIUM PHOSPHATE

DMF 401172024

ORGANON INCInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 7581963

ANTIBIOTICOS SPAInactivePREDNISOLONE SODIUM PHOSPHATE BULK

DMF 23761974

DIOSYNTHInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 38191980

PFIZER INCInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 93071991

NEWCHEM SPAInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 218222008

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

Products (1)

#001 — EQ 0.25% PHOSPHATE

0 patents0 exclusivities▴

OINTMENT;OPHTHALMIC, OTIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.