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VIRAZOLE

NDA

RIBAVIRIN | N018859 | BAUSCH HEALTH US 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Ribavirin* (2023)

Total Spending

$279K

Total Claims

1,990

Beneficiaries

1,130

Avg Cost/Unit

$1.59

Spending Trend

$183K(2019)→$243K(2020)→$228K(2021)→$282K(2022)→$279K(2023)

YoY Change:+11.7%

5yr CAGR:+6.4%

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

API Supply Chain5 active DMFs8 inactive

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

SIEGFRIED EVIONNAZ SARIBAVIRIN

DMF 121561996

YUHAN CHEMICAL INCRIBAVIRIN USP, 1H-1,2,4-TRIAZOLE-3-CARBOXAMIDE, 1-BETA-D-RIBOFURANOSYL

DMF 156112001

CURIA ITALY SRLRIBAVIRIN USP-EP

DMF 157002001

APITORIA PHARMA PRIVATE LTDRIBAVIRIN USP

DMF 189732005

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTDRIBAVIRIN

DMF 268452012

ORGAMOL SAInactiveRIBAVIRIN

DMF 56871985

HEINRICH MACK NACHFInactiveRIBAVIRIN

DMF 64961986

YAMASA CORPInactiveRIBAVIRIN

DMF 127661997

XINXIANG PHARMACEUTICAL CO LTDInactiveRIBAVIRIN NON-STERILE BULK FORM

DMF 156552001

BIDACHEM SPAInactiveRIBAVIRIN

DMF 157562001

ZHEJIANG CHENG YI PHARMACEUTICAL CO LTDInactiveRIBAVIRIN (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 192132006

EUTICALS SPAInactiveRIBAVIRIN

DMF 230042009

ERREDUE SPA INNOVATIVE CHEMICAL AND LIFEInactiveRIBAVIRIN USP EP

DMF 230232009

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

Products (1)

#001 — 6GM/VIAL

RLD

0 patents0 exclusivities▴

FOR SOLUTION;INHALATION | Approved: Dec 31, 1985

No patent or exclusivity listings for this strength.