Viewing data from:

PREZCOBIX

NDA

COBICISTAT; DARUNAVIR ETHANOLATE | N205395 | JANSSEN PRODUCTS LP

2 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Expiring < 1yr (1)Active (2)TodayPED (+6 mo)

2027

2028

2029

2030

2031

2032

2033

Today

7700645

Jun. 26, 2027

8148374

Sep. 3, 2029

10039718

Oct. 6, 2032

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$80.00

per ea

Lowest NADAC/Unit

$80.00

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59676057530PREZCOBIX 800 MG-150 MG TABLET	$80.00	EA	Brand	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$1753.78

Highest Price

$2355.16

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59676-0578-30PREZCOBIX 675MG/150MG TAB,ORAL	$2355.16	FSS	Janssen Products, LP	09/28/2030
59676-0578-30PREZCOBIX 675MG/150MG TAB,ORAL	$1846.45	Big4	Janssen Products, LP	09/28/2030
59676-0575-30PREZCOBIX800MG/150MG TAB	$2355.16	FSS	Janssen Products, LP	09/28/2030
59676-0575-30PREZCOBIX800MG/150MG TAB	$1753.78	Big4	Janssen Products, LP	09/28/2030

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

Medicare Part D Spending

CMS annual spending data for Prezcobix (2024)

Total Spending

$255.4M

Total Claims

99,872

Beneficiaries

11,230

Avg Cost/Unit

$81.22

Spending Trend

$270.1M(2019)→$268.3M(2020)→$261.9M(2021)→$265.4M(2022)→$271.8M(2023)→$255.4M(2024)

YoY Change:-3.1%

5yr CAGR:+4.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

18 letters from Drugs@FDA

Date	Submission	Document
Mar 3, 2026	SUPPL -29	View Letter (PDF)
Mar 25, 2025	SUPPL -28	View Letter (PDF)
Apr 3, 2023	SUPPL -25	View Letter (PDF)
Oct 21, 2022	SUPPL -24	View Letter (PDF)
Apr 15, 2022	SUPPL -22	View Letter (PDF)
Jul 27, 2021	SUPPL -20	View Letter (PDF)
Dec 23, 2020	SUPPL -18	View Letter (PDF)
Aug 3, 2020	SUPPL -16	View Letter (PDF)
Jun 4, 2019	SUPPL -14	View Letter (PDF)
Feb 13, 2019	SUPPL -12	View Letter (PDF)
Sep 12, 2018	SUPPL -10	View Letter (PDF)
Jun 5, 2018	SUPPL -9	View Letter (PDF)
Jan 30, 2018	SUPPL -7	View Letter (PDF)
Jan 30, 2018	SUPPL -6	View Letter (PDF)
Jun 15, 2017	SUPPL -4	View Letter (PDF)
Oct 12, 2016	SUPPL -2	View Letter (PDF)
Apr 4, 2016	SUPPL -1	View Letter (PDF)
Feb 2, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 150MG;EQ 800MG BASE

RLD

3 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 29, 2015

Patents (3) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7700645	Dec 26, 2026PED: Jun 26, 2027	PED	Yes	Yes	—	—
8148374	Sep 3, 2029	—	Yes	Yes		—
10039718	Oct 6, 2032	—	—	Yes	—	—

#002 — 150MG;EQ 675MG BASE

RLD

3 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 21, 2025