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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment NCT07393659	Phase 3	Recruiting	ViiV Healthcare	181	2026-07-21 → 2032-09-14

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 1 NDC

Highest NADAC/Unit

$156.58

per ea

Lowest NADAC/Unit

$156.58

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
49702025018RUKOBIA ER 600 MG TABLET	$156.58	EA	Brand	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$6016.14

Highest Price

$8838.37

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
49702-0250-18RUKOBIA 600MG TAB	$6016.14	Big4	ViiV HealthCare Company	08/14/2026
49702-0250-18RUKOBIA 600MG TAB	$8838.37	FSS	ViiV HealthCare Company	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Rukobia (2024)

Total Spending

$115.0M

Total Claims

12,716

Beneficiaries

1,505

Avg Cost/Unit

$147.93

Spending Trend

$6.7M(2020)→$38.9M(2021)→$63.9M(2022)→$91.2M(2023)→$115.0M(2024)

YoY Change:-1.3%

5yr CAGR:+3.2%

Source: CMS Medicare Part D Spending by Drug (2024). 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	—	—