Viewing data from:

APRETUDE

NDA

CABOTEGRAVIR | N215499 | VIIV HEALTHCARE CO

1 strength4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Expired (1)Active (3)TodayExclusivity

2026

2027

2028

2029

2030

2031

Today

Feb. 4, 2031

Apr. 28, 2026

Sep. 15, 2031

Sep. 15, 2031

NCE

Jan. 21, 2026

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
Cabotegravir-Hormone PK/PD Interactions for HIV Prevention NCT07672717	Phase 1	Recruiting	Johns Hopkins University	32	2026-07 → 2031-12

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

Medicare Part D Spending

CMS annual spending data for Apretude (2023)

Total Spending

$10.7M

Total Claims

2,642

Beneficiaries

708

Avg Cost/Unit

$1337.92

Spending Trend

$2.7M(2022)→$10.7M(2023)

YoY Change:+3.2%

5yr CAGR:+3.2%

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

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

CIPLA LTDCABOTEGRAVIR

DMF 379392023

APITORIA PHARMA PRIVATE LTDCABOTEGRAVIR (STERILE)

DMF 413092025

MATRIX PHARMACORP PRIVATE LTDCABOTEGRAVIR

DMF 418442025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Apr 21, 2025	SUPPL -9	View Letter (PDF)
Sep 24, 2024	SUPPL -8	View Letter (PDF)
Dec 14, 2023	SUPPL -4	View Letter (PDF)
Feb 28, 2023	SUPPL -2	View Letter (PDF)
Dec 22, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 600MG/3ML (200MG/ML)

RLD

4 patents1 exclusivity▴

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Approved: Dec 20, 2021

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8410103	Feb 4, 2031	—	Yes	Yes	—	—
10927129	Apr 28, 2026	—	Yes	Yes	—	—
11224597	Sep 15, 2031	—	—	Yes	—	—
12138264	Sep 15, 2031	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
NCE	Jan 21, 2026	Expired