Viewing data from:

VIVJOA

NDA

OTESECONAZOLE | N215888 | MYCOVIA PHARMACEUTICALS INC

1 strength5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Apr. 22, 2031

Apr. 22, 2031

Mar. 17, 2036

Mar. 17, 2036

May. 9, 2033

NCE

Apr. 26, 2027

GAIN

Apr. 26, 2032

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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Platform Trial For Cryptococcal Meningitis (PLATFORM-CM)NCT06666322	Phase 2/3	Recruiting	University of Minnesota	2,000	2025-05-28 → 2032-04-21

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

Medicare Part D Spending

CMS annual spending data for Vivjoa (2023)

Total Spending

$222K

Total Claims

Beneficiaries

Avg Cost/Unit

$162.41

Spending Trend

$95K(2022)→$222K(2023)

YoY Change:+4.3%

5yr CAGR:+4.3%

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 12, 2024	SUPPL -2	View Letter (PDF)
Apr 27, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MG

RLD

5 patents2 exclusivities▴

CAPSULE;ORAL | Approved: Apr 26, 2022

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8236962	Apr 22, 2031	—	Yes	Yes	—	—
8754227	Apr 22, 2031	—	—	—		—
9840492	Mar 17, 2036	—	Yes	Yes	—	—
10414751	Mar 17, 2036	—	Yes	Yes	—	—
11247981	May 9, 2033	—	—	—		—

Exclusivities (2)

Code	Date	Status
GAIN	Apr 26, 2032	Active
NCE	Apr 26, 2027	< 1 year