Viewing data from:

RUKOBIA

NDA

FOSTEMSAVIR TROMETHAMINE | N212950 | VIIV HEALTHCARE CO

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

Today

7745625

Nov. 19, 2027

8168615

Jul. 13, 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 Rukobia (2023)

Total Spending

$91.2M

Total Claims

9,968

Beneficiaries

1,227

Avg Cost/Unit

$149.94

Spending Trend

$6.7M(2020)→$38.9M(2021)→$63.9M(2022)→$91.2M(2023)

YoY Change:+7.0%

5yr CAGR:+4.8%

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
Feb 14, 2024	SUPPL -4	View Letter (PDF)
Jul 6, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 600MG BASE

RLD

2 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jul 2, 2020

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7745625	Nov 19, 2027	—	Yes	—	—	—
8168615	Jul 13, 2029	—	—	Yes	—	—