Viewing data from:

COMPLERA

NDA

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE | N202123 | GILEAD SCIENCES INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

2032

2033

Today

10857102

Jan. 14, 2033

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

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
JANSSEN SCIENCES IRELAND UNLIMITED COMPANY et al v. LAURUS LABS, LTD. et al 3:2025cv02049 3 patentsANDA 220232emtricitabine, rilpivirine, and tenofovir disoproxil fumarate	D.N.J.	2025-03-24	Active	—
Janssen Pharmaceutica, N.V. et al v. Mylan Pharmaceuticals, Inc. et al 1:2015cv00152 3 patentsANDA 208452emtricitabine, rilpivirine, and tenofovir disoproxil fumarate	N.D. W. Va.	2015-09-02	Terminated 2017-07-06	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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

$130.14

per ea

Lowest NADAC/Unit

$130.14

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61958110101COMPLERA TABLET	$130.14	EA	Brand	$114.99	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$2444.76

Highest Price

$2444.76

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61958-1101-01COMPLERA TABLETS	$2444.76	FSS	Gilead Sciences, Inc.	09/29/2026
61958-1101-01COMPLERA TABLETS	$2444.76	Big4	Gilead Sciences, Inc.	09/29/2026

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

Medicare Part D Spending

CMS annual spending data for Complera (2024)

Total Spending

$22.7M

Total Claims

5,950

Beneficiaries

700

Avg Cost/Unit

$119.73

Spending Trend

$51.9M(2019)→$37.1M(2020)→$31.1M(2021)→$28.4M(2022)→$25.7M(2023)→$22.7M(2024)

YoY Change:-1.9%

5yr CAGR:+4.4%

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Nov 29, 2019	SUPPL -31	View Letter (PDF)
Oct 31, 2018	SUPPL -29	View Letter (PDF)
Apr 12, 2017	SUPPL -27	View Letter (PDF)
Feb 25, 2016	SUPPL -21	View Letter (PDF)
Feb 25, 2016	SUPPL -24	View Letter (PDF)
Feb 11, 2016	SUPPL -23	View Letter (PDF)
May 11, 2015	SUPPL -20	View Letter (PDF)
Sep 17, 2014	SUPPL -18	View Letter (PDF)
Jun 10, 2014	SUPPL -16	View Letter (PDF)
Dec 17, 2013	SUPPL -12	View Letter (PDF)
Oct 25, 2013	SUPPL -15	View Letter (PDF)
Jun 21, 2013	SUPPL -11	View Letter (PDF)
Jan 30, 2013	SUPPL -3	View Letter (PDF)
Aug 15, 2012	SUPPL -6	View Letter (PDF)
Aug 12, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG;EQ 25MG BASE;300MG

RLDAB

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Aug 10, 2011

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10857102	Jan 14, 2033	—	—	Yes	—	—