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BETAMETHASONE VALERATE

NDA

BETAMETHASONE VALERATE | N018865 | FOUGERA PHARMACEUTICALS LLC

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

160 trials from ClinicalTrials.gov — 13 recruiting, 2 active, 99 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder NCT07879625	N/A	Active	Zichao Zhang	64	2025-06-03 → 2026-10-26
Transdermal Versus Intralesional Betamethasone for Keloids NCT07835438	N/A	Active	First Hospital of China Medical University	45	2025-04-25 → 2026-11-29
Comparison of Post-Inflammatory Pigment Alteration After Psoriasis Treatment (PIPA - Dermavant)NCT05981118	Phase 2/3	By Invitation	Wake Forest University Health Sciences	40	2024-07-15 → 2027-12
Evaluation of the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis NCT07668895	Phase 2/3	Not Yet Recruiting	Peking Union Medical College Hospital	126	2026-11 → 2028-07
New Topical Treatment in Patchy Alopecia Areata NCT07696585	N/A	Not Yet Recruiting	Sohag University	60	2026-06-28 → 2027-12-28
Azithromycin in Atopic Dermatitis NCT07713186	Phase 4	Not Yet Recruiting	Cairo University	40	2026-08-01 → 2027-01
Transconjunctival Versus Transcutaneous Betamethasone for Upper Eyelid Retraction in TED NCT07866261	N/A	Not Yet Recruiting	Assiut University	54	2026-10-10 → 2028-03-01
Comparing Three Epidural Steroid Injection Approaches for Lumbar Radicular Pain NCT07813988	Phase 4	Not Yet Recruiting	Benha University	99	2026-10 → 2028-02
Hyaluronic Acid and I-PRF Mixture for TMJ Disc Displacement Management NCT07683650	N/A	Recruiting	Mansoura University	72	2026-01-06 → 2027-02
Betamethasone vs Dextrose Injections in Trigger Finger NCT07681804	N/A	Recruiting	Istanbul University - Cerrahpasa	42	2026-06-30 → 2027-05

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs

Highest NADAC/Unit

$0.5536

per gm

Lowest NADAC/Unit

$0.4836

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00168003315BETAMETHASONE VALER 0.1% OINTM	$0.5536	GM	Generic	—	2026-10-21
00168003346BETAMETHASONE VALER 0.1% OINTM	$0.4836	GM	Generic	—	2026-10-21

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

API Supply Chain6 active DMFs8 inactive

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

TAPI NL BVBETAMETHASONE VALERATE

DMF 41181981

FARMABIOS SPABETAMETHASONE VALERATE

DMF 127491997

HALCYON LABS PRIVATE LTDBETAMETHASONE VALERATE USP

DMF 213202008

SYMBIOTEC PHARMALAB PRIVATE LTDBETAMETHASONE VALERATE, USP (MICRONIZED)

DMF 220622008

HENAN LIHUA PHARMACEUTICAL CO LTDBETAMETHASONE VALERATE

DMF 358652022

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDBETAMETHASONE VALERATE

DMF 380632023

GLAXOCHEM LTDInactiveBETAMETHASONE VALERATE

DMF 45781982

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveBETAMETHASONE VALERATE USP XX

DMF 54651984

DIOSYNTH BVInactiveBETAMETHASONE VALERATE

DMF 55541984

SCHERING AGInactiveBETAMETHASONE VALERATE

DMF 58631985

PFIZER INCInactiveBETAMETHASONE VALERATE

DMF 64051986

QUATRUMInactiveBETAMETHASONE VALERATE

DMF 70491987

HOECHST MARION ROUSSEL SAInactiveBETAMETHASONE VALERATE USP, BP

DMF 73101988

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveBETAMETHASONE VALERATE USP

DMF 226512008

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

Products (1)

#001 — EQ 0.1% BASE

RLDAB

0 patents0 exclusivities▴

OINTMENT;TOPICAL | Approved: Aug 31, 1983

No patent or exclusivity listings for this strength.