Viewing data from:

ORBACTIV

NDA

ORITAVANCIN DIPHOSPHATE | N206334 | 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 Orbactiv (2023)

Total Spending

$231K

Total Claims

Beneficiaries

Avg Cost/Unit

$22.67

Spending Trend

$631K(2019)→$719K(2020)→$1.0M(2021)→$643K(2022)→$231K(2023)

YoY Change:-63.9%

5yr CAGR:+10.6%

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 Orbactiv (2023)

Total Spending

$1.8M

Total Claims

568

Beneficiaries

363

ASP Price

—

HCPCS: J2407 — Injection, oritavancin (orbactiv), 10 mg

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jan 19, 2022	SUPPL -7	View Letter (PDF)
Jul 27, 2021	SUPPL -6	View Letter (PDF)
Dec 12, 2019	SUPPL -5	View Letter (PDF)
Mar 28, 2018	SUPPL -4	View Letter (PDF)
Oct 19, 2016	SUPPL -3	View Letter (PDF)
Jan 21, 2016	SUPPL -2	View Letter (PDF)
Aug 7, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 400MG BASE/VIAL

RLD

4 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Aug 6, 2014

Patents (4)

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