Viewing data from:

KIMYRSA

NDA

ORITAVANCIN DIPHOSPHATE | N214155 | MELINTA THERAPEUTICS LLC

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2027

2028

2029

2030

2031

2032

2033

2034

2035

Today

Aug. 29, 2029

Jul. 16, 2035

Apr. 26, 2030

Aug. 29, 2029

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Kimyrsa (2023)

Total Spending

$1.0M

Total Claims

198

Beneficiaries

102

Avg Cost/Unit

$5135.20

Spending Trend

$627K(2022)→$1.0M(2023)

YoY Change:+31.9%

5yr CAGR:+31.9%

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

Medicare Part B Spending

CMS physician-administered drug spending for Kimyrsa (2023)

Total Spending

$8.4M

Total Claims

1,753

Beneficiaries

1,177

ASP Price

—

HCPCS: J2406 — Injection, oritavancin (kimyrsa), 10 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 27, 2021	SUPPL -1	View Letter (PDF)
Mar 16, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1.2GM BASE/VIAL

RLD

4 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Mar 12, 2021

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8420592	Aug 29, 2029	—	—	—		—
9649352	Jul 16, 2035	—	Yes	Yes	—	—
9682061	Apr 26, 2030	—	—	—		—
12514899	Aug 29, 2029	—	—	—		—