DOVATO Drug Patent Profile

When do Dovato patents expire, and when can generic versions of Dovato launch?

Dovato is a drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and ninety-three patent family members in forty-nine countries.

The generic ingredient in DOVATO is dolutegravir sodium; lamivudine. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolutegravir sodium; lamivudine profile page.

DrugPatentWatch^® Generic Entry Outlook for Dovato

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 24, 2031. This may change due to patent challenges or generic licensing.

There have been twenty-four 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 DOVATO

International Patents:	293
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	7
Patent Applications:	43
Drug Prices:	Drug price information for DOVATO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DOVATO
What excipients (inactive ingredients) are in DOVATO?	DOVATO excipients list
DailyMed Link:	DOVATO at DailyMed

See drug prices for DOVATO

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

Constraining patent/regulatory exclusivity:

11,234,985

NDA:

211994

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 DOVATO

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

Sponsor	Phase
ViiV Healthcare	Phase 1
Saint Michael's Medical Center	Phase 4
Societa' Italiana Di Malattie Infettive E Tropicali	Phase 3

See all DOVATO clinical trials

Pharmacology for DOVATO

Drug Class	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	HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Cation Transporter 2 Inhibitors

Paragraph IV (Patent) Challenges for DOVATO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DOVATO	Tablets	dolutegravir sodium; lamivudine	50 mg/300 mg	211994	1	2019-07-30

US Patents and Regulatory Information for DOVATO

DOVATO is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 11,234,985.

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
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	11,234,985		Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	8,129,385*PED				Y
Viiv Hlthcare	DOVATO	dolutegravir sodium; lamivudine	TABLET;ORAL	211994-001	Apr 8, 2019		RX	Yes	Yes	9,242,986*PED				Y

International Patents for DOVATO

When does loss-of-exclusivity occur for DOVATO?

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

African Regional IP Organization (ARIPO)

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Turkey

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 DOVATO around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1874117
Eurasian Patent Organization	032868	КОМБИНАЦИЯ ДЛЯ ЛЕЧЕНИЯ ВИЧ-ИНФЕКЦИИ (COMBINATION FOR TREATING HIV INFECTION)
Hungary	E056603
Morocco	29460	DERIVE POLYCYCLIQUE DE LA CARBAMOYLPYRIDONE A ACTIVITE INHIBITRICE SUR L'INTEGRASE DU VIH
Russian Federation	2527451	СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ (SYNTHESIS OF CARBAMOYL PYRIDONE INHIBITORS OF HIV INTEGRASE AND INTERMEDIATE COMPOUNDS)

Supplementary Protection Certificates for DOVATO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2932970	2018C/041	Belgium		PRODUCT NAME: EEN COMBINATIE OMVATTENDE DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN (BIJVOORBEELD DOLUTEGRAVIRNATRIUM) EN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN (BIJVOORBEELD RILPIVIRINEHYDROCHLORIDE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518
1874117	300676	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
2932970	CA 2018 00036	Denmark		PRODUCT NAME: KOMBINATION OMFATTENDE DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. DOLUTEGRAVIRNATRIUM, OG RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. RILPIVIRINHYDROCHLORID; REG. NO/DATE: EU/1/18/1282/001-002 20180518
3494972	CA 2024 00022	Denmark		PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, INKLUSIV DOLUTEGRAVIRNATRIUM, OG LAMIVUDIN; REG. NO/DATE: EU/1/19/1370 20190703
2465580	PA2021512,C2465580	Lithuania		PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217

Market Dynamics and Financial Trajectory for Dovato

Introduction

Dovato, a groundbreaking two-drug regimen for the treatment of HIV, has been at the forefront of the HIV market since its approval in 2019. Developed by GlaxoSmithKline (GSK) and its majority-owned partner ViiV Healthcare, Dovato combines dolutegravir and lamivudine into a single, once-daily pill. Here, we delve into the market dynamics and financial trajectory of Dovato, highlighting its impact, challenges, and future prospects.

Market Approval and Initial Impact

Dovato was approved by the FDA in April 2019 as the first single-tablet, two-drug regimen for newly diagnosed HIV patients. This approval marked a significant shift in the treatment paradigm, aiming to reduce the burden of multiple medications and potential drug interactions, especially for older patients[1].

Competitive Landscape

The HIV market is highly competitive, with Gilead Sciences Inc. being a major player. Gilead's Biktarvy, a three-drug regimen, has dominated the market since its launch in February 2018. Despite Dovato's entry, Biktarvy continues to hold a substantial market share, with sales significantly outpacing those of Dovato in the initial years[4].

Pricing Strategy

GSK priced Dovato at a 26% discount to Biktarvy, aiming to attract patients and healthcare providers. However, this pricing strategy has not significantly eroded Biktarvy's market share. RBC analysts noted that Dovato's impact on Biktarvy prescriptions has been "negligible"[4].

Sales Performance

In the initial period following its launch, Dovato's sales were modest. By the end of September 2019, Dovato had generated roughly $30 million in sales, compared to Biktarvy's $3.2 billion over the same period. However, GSK has seen gradual growth in Dovato's sales over time. In the third quarter of 2023, Dovato delivered £477 million, reflecting growing market acceptance and healthcare provider confidence[3][4].

Market Acceptance and Growth

Despite initial skepticism from doctors about switching patients from three-drug regimens to two-drug regimens, GSK has made significant strides in building confidence. The company has continued to generate real-world evidence and conduct ongoing studies, such as the Gemini studies, to support Dovato's efficacy and safety. This has led to increased acceptance among healthcare providers, with Dovato firmly consolidating its position as the leading oral two-drug regimen[1][3].

Financial Trajectory

GSK's HIV business, driven largely by Dovato and other two-drug regimens like Juluca, has been a key growth driver. In the third quarter of 2023, GSK's HIV business delivered sales of £1.6 billion, growing 15% year-over-year. This growth was driven by strong patient demand and favorable tender phasing in international markets. Dovato's sales have contributed significantly to this growth, with the drug now a substantial part of GSK's portfolio[3].

Patent Exclusivity

Dovato's financial trajectory is also influenced by its patent exclusivity. The composition-of-matter patent for dolutegravir, a key component of Dovato, expires in April 2028 in the US and July 2029 in Europe. However, formulation and other patents extend the exclusivity period in the US until December 2029 for Dovato and July 2030 for Juluca, providing a longer period of protection against generic competition[3].

Long-Acting Injectables and Prevention

In addition to oral regimens, GSK's HIV portfolio includes long-acting injectable medicines like Cabenuva and Apretude. Cabenuva, which competes in the same market as oral regimens, has seen strong patient demand and high market access and reimbursement rates. Apretude, the world's first long-acting injectable for HIV prevention, has also shown promising momentum, particularly in the US. These products further bolster GSK's position in the HIV market and contribute to its overall financial performance[3].

Challenges and Future Prospects

While Dovato has made significant strides, it still faces challenges in fully displacing three-drug regimens. Doctors' confidence in two-drug regimens is increasing, but it remains a gradual process. GSK's continued investment in real-world evidence and clinical studies is crucial for further market penetration. The company's ability to navigate patent expirations and maintain market share will also be key factors in Dovato's long-term financial trajectory[1][4].

Key Takeaways

• Market Approval: Dovato was approved as the first single-tablet, two-drug regimen for HIV in 2019.
• Competitive Landscape: Dovato competes with Gilead's Biktarvy, but has not significantly eroded its market share.
• Pricing Strategy: Dovato is priced at a 26% discount to Biktarvy.
• Sales Performance: Dovato's sales have grown gradually, with £477 million in the third quarter of 2023.
• Market Acceptance: Growing acceptance among healthcare providers driven by real-world evidence and clinical studies.
• Financial Trajectory: Dovato is a key growth driver for GSK's HIV business, with significant contributions to overall sales.
• Patent Exclusivity: Extended exclusivity period in the US until December 2029.
• Long-Acting Injectables and Prevention: Strong performance of Cabenuva and Apretude adds to GSK's HIV portfolio.

FAQs

Q: What is Dovato and how does it differ from other HIV treatments? A: Dovato is a single-tablet, two-drug regimen combining dolutegravir and lamivudine, designed for newly diagnosed HIV patients. It differs from traditional three-drug regimens, aiming to reduce the burden of multiple medications and potential drug interactions.

Q: How has Dovato performed in the market since its approval? A: Dovato has seen gradual growth in sales, but its impact on Gilead's Biktarvy prescriptions has been negligible in the initial years. However, it has consolidated its position as the leading oral two-drug regimen.

Q: What is the pricing strategy for Dovato? A: Dovato is priced at a 26% discount to Gilead's Biktarvy, aiming to attract patients and healthcare providers.

Q: How does Dovato's patent exclusivity affect its financial trajectory? A: Dovato's composition-of-matter patent expires in April 2028 in the US and July 2029 in Europe, but formulation and other patents extend exclusivity in the US until December 2029.

Q: What other HIV products contribute to GSK's financial performance? A: In addition to Dovato, GSK's long-acting injectable medicines like Cabenuva and Apretude contribute significantly to its HIV business and overall financial performance.

Sources

1. S&P Global Market Intelligence: "Competition in HIV market to intensify as GSK wins 2-drug approval with Dovato"[1]
2. Shionogi Inc.: "1st Quarter of Fiscal 2023 Financial Results"[2]
3. Seeking Alpha: "GSK plc (GSK) Q3 2023 Earnings Call Transcript"[3]
4. Biopharma Dive: "GSK's plan to take over the HIV drug market hasn't worked out"[4]
5. Shionogi Inc.: "Fiscal 2023 Financial Results"[5]