STRIBILD Drug Patent Profile

Which patents cover Stribild, and when can generic versions of Stribild launch?

Stribild 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 four hundred and one patent family members in forty-eight countries.

The generic ingredient in STRIBILD is cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Stribild

Stribild was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 6, 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 STRIBILD

International Patents:	401
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	27
Patent Applications:	182
Drug Prices:	Drug price information for STRIBILD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STRIBILD
What excipients (inactive ingredients) are in STRIBILD?	STRIBILD excipients list
DailyMed Link:	STRIBILD at DailyMed

See drug prices for STRIBILD

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

Constraining patent/regulatory exclusivity:

10,039,718*PED

NDA:

203100

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 STRIBILD

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

Sponsor	Phase
University of California, Los Angeles	Phase 1/Phase 2
Gilead Sciences	Phase 1/Phase 2
ViiV Healthcare	N/A

See all STRIBILD clinical trials

Pharmacology for STRIBILD

Drug Class	Cytochrome P450 3A Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for STRIBILD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STRIBILD	Tablets	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	150 mg/150 mg/ 200 mg/300 mg	203100	1	2018-10-04

US Patents and Regulatory Information for STRIBILD

STRIBILD is protected by seven US patents.

This potential generic entry date is based on patent 10,039,718.

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	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	7,176,220*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,981,103*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	8,633,219*PED				Y
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012		RX	Yes	Yes	7,635,704*PED				Y

Expired US Patents for STRIBILD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	5,922,695*PED
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	9,457,036
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	6,642,245*PED
Gilead Sciences Inc	STRIBILD	cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	203100-001	Aug 27, 2012	5,814,639*PED

International Patents for STRIBILD

When does loss-of-exclusivity occur for STRIBILD?

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

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Peru

Poland

Portugal

San Marino

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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 STRIBILD around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2021004264	組み合わせ抗ウイルス治療のための組成物および方法 (COMPOSITION AND METHOD FOR COMBINATION ANTIVIRAL TREATMENT)
New Zealand	594214	TABLETS COMPRISING COBICISTAT, ELVITEGRAVIR, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE FOR COMBINATION THERAPY
Portugal	1583542
South Korea	101659971

Supplementary Protection Certificates for STRIBILD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1564210	122013000088	Germany		PRODUCT NAME: ELVITEGRAVIR ODER EIN HYDRAT, SOLVAT, TAUTOMER ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 20130524
2487162	17C1002	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE ET LE DARUNAVIR OU SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVATE, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; REGISTRATION NO/DATE: EU/1/14/967 20141121
2049506	300780	Netherlands		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
3150586	CA 2020 00021	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIR ETHANOLAT, OG EMTRICITABIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/17/1225 20170925

Market Dynamics and Financial Trajectory for the Drug: STRIBILD

Introduction

STRIBILD, a single-tablet regimen (STR) developed by Gilead Sciences, was approved by the US FDA in 2012 for the treatment of HIV-1 infection. This article delves into the market dynamics and financial trajectory of STRIBILD, highlighting its launch, pricing, market performance, and the impact of various factors on its success.

Approval and Launch

STRIBILD was approved by the FDA in August 2012, following a 13-1 vote in favor by the FDA's Antiviral Drugs Advisory Committee. The drug was made available almost immediately, marking a significant milestone for Gilead Sciences[1].

Pricing Strategy

The pricing of STRIBILD was a critical factor in its market reception. The wholesale acquisition cost (WAC) was set at $2,342.47 per month, which translates to an annual cost range of $26,000 to $34,000. This pricing represented a 33% premium over Gilead's existing triple combination therapy, Atripla, and was 7% higher than Merck & Co's HIV integrase inhibitor, Isentress. Despite being at the lower end of the expected cost range, the pricing was still a point of contention, particularly with regards to its impact on governmental AIDS Drug Assistance Programs (ADAPs)[1].

Market Positioning

STRIBILD was positioned as a key growth driver for Gilead Sciences, particularly in the first-line treatment setting. It competed directly with other dominant HIV therapies such as Atripla, Isentress, and Reyataz (in combination with Truvada). The convenience of a single-tablet regimen was a significant selling point, as it simplified treatment for patients compared to multi-tablet regimens[1].

Initial Market Performance

The initial focus for STRIBILD was on new patients, given the lack of data on the safety of switching therapies. Despite this, the drug saw significant uptake, partly due to its convenience and the established trust in Gilead's HIV treatment portfolio. However, its success was also dependent on its ability to compete with other established therapies and to secure pricing and reimbursement approvals, especially in European markets[1].

Safety and Monitoring

The labeling of STRIBILD included slightly more stringent kidney monitoring compared to Atripla, but this was considered a routine part of HIV/AIDS treatment and did not pose a significant commercial setback. The drug's safety profile was generally in line with expectations, although long-term data on switching therapies was initially limited[1].

Competitive Landscape

STRIBILD operated in a highly competitive HIV treatment market. It faced competition from other single-tablet regimens like Complera (rilpivirine + tenofovir + emtricitabine) and later from newer therapies such as Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide). Biktarvy, in particular, has been a market leader since 2019, with sales amounting to $4.6 billion, and continues to drive growth in the HIV market[4].

Financial Performance

The financial performance of STRIBILD was closely tied to Gilead's overall HIV franchise. While STRIBILD was a key growth driver, its impact was part of a broader trend in Gilead's HIV product sales. In 2020, Gilead's HIV product sales decreased by 7% in the fourth quarter and increased by 3% for the full year, primarily due to the loss of exclusivity for Truvada and Atripla in the United States. However, this decline was offset by the continued uptake of newer therapies like Biktarvy and Descovy[3].

Legal and Regulatory Challenges

STRIBILD, along with other TDF-based drugs like Truvada and Viread, has been embroiled in legal challenges. Lawsuits have alleged that Gilead knowingly withheld a safer alternative, TAF (tenofovir alafenamide), to protect profits from TDF-based drugs. These lawsuits claim that Gilead prioritized financial gains over patient safety, leading to kidney and bone injuries in patients. This legal landscape could impact the long-term financial trajectory of STRIBILD and other TDF-based products[2].

Future Outlook

The future success of STRIBILD and similar HIV therapies will be influenced by several factors:

• Patient Switching: Patients switching from older STRs to newer, safer alternatives like Biktarvy and Descovy.
• Market Competition: Increasing competition from ViiV Healthcare's two-drug regimens like Dovato and Juluca.
• Generic Erosion: The impact of generic versions of major brands on market dynamics.
• New Therapies: The introduction of new salvage therapies and INSTIs (integrase strand transfer inhibitors) which are expected to dominate the treatment paradigm[4].

Key Takeaways

• STRIBILD's Launch: Approved in 2012 with a competitive pricing strategy.
• Market Position: Positioned as a key growth driver in the first-line treatment setting.
• Safety and Monitoring: Required slightly more stringent kidney monitoring but generally safe.
• Competitive Landscape: Faced competition from other single-tablet regimens and newer therapies.
• Financial Performance: Part of Gilead's broader HIV franchise performance.
• Legal Challenges: Embroiled in lawsuits related to the use of TDF over TAF.

FAQs

What is STRIBILD and how is it used?

STRIBILD is a single-tablet regimen (STR) used for the treatment of HIV-1 infection. It contains elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate.

How was STRIBILD priced upon its launch?

STRIBILD was priced at $2,342.47 per month, representing a 33% premium over Gilead's Atripla and 7% higher than Merck & Co's Isentress.

What were the initial market challenges for STRIBILD?

The initial focus was on new patients due to lack of data on switching therapies, and it faced competition from established HIV therapies.

What legal issues has STRIBILD faced?

STRIBILD, along with other TDF-based drugs, has been involved in lawsuits alleging that Gilead withheld a safer alternative, TAF, to protect profits.

How has the market for HIV treatments evolved since STRIBILD's launch?

The market has seen significant growth driven by newer therapies like Biktarvy, increased competition from two-drug regimens, and the impact of generic erosion.

What is the future outlook for STRIBILD and similar HIV therapies?

The future will be influenced by patient switching to newer therapies, market competition, generic erosion, and the introduction of new salvage therapies and INSTIs.

Sources

1. S&P Global: "US FDA Clears Gilead's Newly Branded Stribild, Focus on New Patients Expected" - August 28, 2012.
2. Lawsuit-Information-Center: "Truvada Lawsuit | Projected Settlement Amounts | February 2024" - October 19, 2024.
3. Gilead Sciences: "Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results" - February 4, 2021.
4. BusinessWire: "World HIV Treatment Forecast and Market Analysis Report 2021-2027" - June 4, 2021.