COMPLERA Drug Patent Profile

Which patents cover Complera, and what generic alternatives are available?

Complera is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are seven 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:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	6
Patent Applications:	89
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

Constraining patent/regulatory exclusivity:

10,857,102

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

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 seven US patents.

This potential generic entry date is based on patent 10,857,102.

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

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	8,592,397		Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	10,857,102		Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	8,716,264		Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	8,841,310		Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	9,457,036		Y
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011		RX	Yes	Yes	7,125,879		Y	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	7,067,522
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	8,716,264
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	5,977,089*PED
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	6,838,464
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	5,814,639*PED
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	9,457,036

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
Australia	2018202635	Therapeutic compositions comprising rilpivirine HCl and tenofovir disoproxil fumarate
Japan	5507791
Norway	326249
Norway	2017064
Denmark	0915894
Eurasian Patent Organization	201390651	ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ РИЛПИВИРИН HCL И ТЕНОФОВИРА ДИЗОПРОКСИЛФУМАРАТ

Supplementary Protection Certificates for COMPLERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	92008	Luxembourg		92008, EXPIRES: 20261128
1632232	93385	Luxembourg		PRODUCT NAME: COMBINAISON DE CHLORHYDRATE DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, EMTRICITABINE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
0513200	SZ 7/2004	Austria
1663240	C20150041 00168	Estonia		PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA) JA TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
1419152	12C0036	France		PRODUCT NAME: COMBINAISON DE RILPIVIRINE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE, TELLES QUE LES SELS D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE ET DE TENOFOVIR, EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
0915894	C00915894/02	Switzerland		PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009

COMPLERA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for COMPLERA

Introduction to COMPLERA

COMPLERA is a fixed-dose combination antiretroviral drug used in the treatment of HIV-1 infection. It combines emtricitabine, rilpivirine, and tenofovir disoproxil fumarate. Understanding the market dynamics and financial trajectory of COMPLERA is crucial for stakeholders in the pharmaceutical industry.

Market Size and Growth

The global HIV drugs market, within which COMPLERA operates, was valued at $32.8 billion in 2022 and is projected to reach $51.1 billion by 2032, growing at a CAGR of 4.5% from 2023 to 2032[1].

Segmentation and Market Share

COMPLERA falls under the multi-class combination drugs segment, which held the largest share in the HIV drugs market in 2022. This segment is driven by the preference for single-tablet regimens (STRs) due to their convenience and adherence benefits[1].

Distribution Channels

The hospital pharmacies segment dominated the HIV drugs market in 2022, including sales of COMPLERA. However, the online pharmacies segment is expected to witness the highest CAGR during the forecast period due to convenience, improvements in logistics, and ease in payment options[1].

Regional Performance

North America, particularly the U.S., has been a significant market for COMPLERA, driven by the presence of major players like Gilead Sciences, advanced healthcare facilities, and high healthcare expenditure. However, the Asia-Pacific region is expected to grow at the highest rate during the forecast period due to rising cases of HIV and increasing purchasing power in countries like China and India[1].

Financial Performance of Gilead Sciences

Gilead Sciences, the manufacturer of COMPLERA, has seen mixed financial results in recent years. For instance, in the third quarter of 2023, Gilead's total revenue was $7.1 billion, which was flat compared to the same period in 2022. The revenue was driven by increased sales in HIV and Oncology, offset by lower Veklury (remdesivir) sales[2].

Impact of Generic Erosion

COMPLERA, like other STRs, faces the threat of generic erosion. The loss of exclusivity for Truvada and Atripla in the United States in October 2020 has led to expected declines in sales of these older STRs. Patients are increasingly switching to newer STRs like Biktarvy, which has outpaced rival STRs to gain market leader status[3][4].

Competition Analysis

The HIV treatment market is highly competitive, with several key players including Gilead Sciences, ViiV Healthcare, and others. COMPLERA competes with other STRs such as Biktarvy, Genvoya, Stribild, and Odefsey. ViiV Healthcare's two-drug regimens, Dovato and Juluca, also pose significant competition[4].

Patient Switching and Uptake

Patients are increasingly switching from older STRs like COMPLERA to newer regimens like Biktarvy due to its efficacy and patient preference. This trend is expected to continue, driving the growth of newer therapies while impacting the sales of older drugs like COMPLERA[4].

Price Dynamics

The HIV treatment market is also influenced by price rises in the U.S. and other regions. While this can drive revenue growth, it also faces regulatory and market pressures to keep prices manageable for patients[4].

Future Outlook

Despite the challenges from generic erosion and competition, the HIV treatment market, including COMPLERA, is expected to grow driven by increasing HIV prevalence, patient switching to newer regimens, and the introduction of new salvage therapies like lenacapavir. However, the market will need to adapt to changing patient needs and competitive landscapes[1][4].

Key Takeaways

• Market Growth: The global HIV drugs market is expected to grow at a CAGR of 4.5% from 2023 to 2032.
• Segment Dominance: Multi-class combination drugs, including COMPLERA, dominate the market.
• Distribution: Hospital pharmacies currently lead, but online pharmacies are growing rapidly.
• Regional Focus: North America is a major market, but Asia-Pacific is expected to grow significantly.
• Financial Performance: Gilead Sciences' revenue is influenced by HIV and Oncology sales, offset by declines in other areas.
• Generic Erosion: COMPLERA faces generic competition, leading to patient switching to newer STRs.
• Competition: The market is highly competitive with several key players and new therapies emerging.

FAQs

Q: What is the projected growth rate of the global HIV drugs market? A: The global HIV drugs market is expected to grow at a CAGR of 4.5% from 2023 to 2032[1].

Q: Which segment dominates the HIV drugs market? A: The multi-class combination drugs segment, which includes COMPLERA, dominates the HIV drugs market[1].

Q: What is the impact of generic erosion on COMPLERA sales? A: Generic erosion leads to expected declines in sales as patients switch to newer STRs like Biktarvy[3][4].

Q: Which region is expected to grow the fastest in the HIV drugs market? A: The Asia-Pacific region is expected to grow at the highest rate during the forecast period[1].

Q: How does patient switching affect the sales of COMPLERA? A: Patients switching from older STRs like COMPLERA to newer regimens like Biktarvy impacts the sales negatively, driving growth for newer therapies[4].

Cited Sources

1. Allied Market Research - HIV Drugs Market Size, Share and Growth Analysis | Report, 2032
2. Biospace - Gilead Sciences Announces Third Quarter 2023 Financial Results
3. Gilead Sciences - Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results
4. Businesswire - World HIV Treatment Forecast and Market Analysis Report 2021-2027
5. Businesswire - Gilead Sciences Announces Second Quarter 2023 Financial Results