COMPLERA Drug Patent Profile

When do Complera patents expire, and what generic alternatives are available?

Complera is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and thirty-four patent family members in fifty-two countries.

The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Complera

Complera was eligible for patent challenges on May 20, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 14, 2033. This may change due to patent challenges or generic licensing.

There have been seventeen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for COMPLERA

International Patents:	334
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	6
Patent Applications:	119
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for COMPLERA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COMPLERA
What excipients (inactive ingredients) are in COMPLERA?	COMPLERA excipients list
DailyMed Link:	COMPLERA at DailyMed

See drug prices for COMPLERA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for COMPLERA

NDA:

202123

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for COMPLERA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
CIHR Canadian HIV Trials Network	Phase 3
Ottawa Hospital Research Institute	Phase 3
Gilead Sciences	Phase 3

See all COMPLERA clinical trials

Pharmacology for COMPLERA

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for COMPLERA

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for COMPLERA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMPLERA	Tablets	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	200 mg/25 mg/ 300 mg	202123	1	2015-05-20

US Patents and Regulatory Information for COMPLERA

COMPLERA is protected by eight US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting COMPLERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes			Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes			Y	Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes			Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes			Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes			Y

Expired US Patents for COMPLERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011

International Patents for COMPLERA

When does loss-of-exclusivity occur for COMPLERA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering COMPLERA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2002220388	L-ENANTIOMER OF CIS-1-(2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5- YL)-5-FLUOROCYTOSINE
Czech Republic	9301835
South Korea	20060038451
Mexico	PA06002437	COMBINACIONES DE UN INHIBIDOR NO NUCLEOSIDO DE LA TRANSCRIPTASA INVERSA CON CONTENIDO DE PIRIMIDINA CON INHIBIDORES DE TRANSCRIPTASA INVERSA. (COMBINATIONS OF A PYRIMIDINE CONTAINING NNRTI WITH RT INHIBITORS.)
Hungary	9202496

Supplementary Protection Certificates for COMPLERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	22/2012	Austria		PRODUCT NAME: KOMBINATION VON RILPIVIRIN UND PHARMAZEUTISCH ANNEHMBAREN ADDITIONSSALZEN VON RILPIVIRIN, EINSCHLIESSLICH DEM HYDROCHLORID VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	CA 2016 00064	Denmark		PRODUCT NAME: KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, EMTRICITABIN OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
1663240	300851	Netherlands		PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1663240	224 5022-2015	Slovakia		PRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
1663240	PA2015035,C1663240	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128