Viewing data from:

CELESTONE SOLUSPAN

NDA

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE | N014602 | ORGANON LLC A SUB OF ORGANON AND CO

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, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study NCT03707795	Early Phase 1	Completed	Edward Kasaraskis	6	2017-08-21 → 2019-01-10
Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy NCT02652884	Phase 4	UNKNOWN	Hospital Italiano de Buenos Aires	110	2016-01 → 2017-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$8.80

per ml

Lowest NADAC/Unit

$8.80

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206011801CELESTONE SOLUSPAN 30 MG/5 ML	$8.80	ML	Brand	$9.46	2026-01-01

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$27.41

Highest Price

$43.05

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
78206-0118-01CELESTONE 6MG/ML SUSP INJ	$43.05	FSS	Organon LLC	01/14/2027
78206-0118-01CELESTONE 6MG/ML SUSP INJ	$27.41	Big4	Organon LLC	01/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Approval Letters

9 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 3MG/ML;EQ 3MG BASE/ML

RLDAB

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.