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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	WVND	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

Medicare Part D Spending

CMS annual spending data for Complera (2023)

Total Spending

$25.7M

Total Claims

6,649

Beneficiaries

782

Avg Cost/Unit

$121.98

Spending Trend

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

YoY Change:+6.9%

5yr CAGR:+6.5%

Source: CMS Medicare Part D Spending by Drug (2023). 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	—	—