ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE - Generic Drug Details

What are the generic sources for abacavir sulfate; dolutegravir sodium; lamivudine and what is the scope of freedom to operate?

Abacavir sulfate; dolutegravir sodium; lamivudine is the generic ingredient in two branded drugs marketed by Viiv Hlthcare and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Abacavir sulfate; dolutegravir sodium; lamivudine has one hundred and fifty-five patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

International Patents:	155
US Patents:	2
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
DailyMed Link:	ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Constraining patent/regulatory exclusivity:

9,242,986*PED

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

9,242,986*PED

Dosage:

TABLET, FOR SUSPENSION;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.

Pharmacology for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

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	Cytochrome P450 1A1 Inhibitors HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

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

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRIUMEQ PD	Tablets for Oral Suspension	abacavir sulfate; dolutegravir sodium; lamivudine	60 mg/5 mg/30 mg	215413	1	2023-03-31
TRIUMEQ	Tablets	abacavir sulfate; dolutegravir sodium; lamivudine	600 mg/50 mg/ 300 mg	205551	5	2017-08-14

US Patents and Regulatory Information for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014		RX	Yes	Yes	8,129,385*PED				Y
Viiv Hlthcare	TRIUMEQ PD	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET, FOR SUSPENSION;ORAL	215413-001	Mar 30, 2022		RX	Yes	Yes	9,242,986*PED				Y

Expired US Patents for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014	5,905,082*PED
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014	6,417,191*PED
Viiv Hlthcare	TRIUMEQ	abacavir sulfate; dolutegravir sodium; lamivudine	TABLET;ORAL	205551-001	Aug 22, 2014	6,294,540*PED

International Patents for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Country	Patent Number	Title	Estimated Expiration
Philippines	12007502373	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase
Japan	5086478
China	101346376	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase

Supplementary Protection Certificates for ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	05C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
1874117	14C0041	France		PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1874117	1490036-9	Sweden		PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116

ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Abacavir Sulfate; Dolutegravir Sodium; Lamivudine

Introduction

Abacavir sulfate, dolutegravir sodium, and lamivudine, combined under the brand name Triumeq, is a pivotal antiretroviral medication for the treatment of HIV/AIDS. This fixed-dose combination has been a significant player in the HIV treatment market since its approval in 2014. Here, we delve into the market dynamics and financial trajectory of this drug.

Approval and Regulatory Framework

Triumeq was approved by the U.S. Food and Drug Administration (FDA) and the European Union in 2014, marking a significant milestone in HIV treatment[1][4][5].

Mechanism of Action and Clinical Use

The combination of abacavir (a nucleoside analog reverse transcriptase inhibitor), dolutegravir (an integrase inhibitor), and lamivudine (another nucleoside analog reverse transcriptase inhibitor) provides a comprehensive approach to inhibiting HIV replication. This combination is indicated for the treatment of HIV infection in adults and adolescents aged 12 years and older, who are either antiretroviral treatment-naive or do not have documented or clinically suspected resistance to any of the three components[1][4].

Clinical Trials and Efficacy

The efficacy of Triumeq was demonstrated in several clinical trials, notably the SINGLE trial, which compared dolutegravir plus abacavir/lamivudine to efavirenz/emtricitabine/tenofovir. The results showed superior viral suppression rates for the dolutegravir-based regimen[1].

Market Position

Triumeq has established itself as a leading treatment option in the HIV market due to its high efficacy, once-daily dosing, and favorable safety profile. The drug's market position is further strengthened by its convenience as a single-tablet regimen, which enhances patient adherence.

Economic Considerations

Cost and Accessibility

A significant factor in the market dynamics of Triumeq is its cost. A year's supply of Triumeq costs approximately $33,000, making it one of the more expensive HIV treatments on the market. This high cost is due to the drug being under patent and not yet available as a generic[1].

Pricing Strategies

To address the high cost and improve accessibility, especially in developing countries, ViiV Healthcare has engaged in pricing strategies. For example, in 2015, ViiV Healthcare struck a deal with Desano Pharmaceuticals to provide a cheaper supply of dolutegravir in China and other developing countries[1].

Financial Performance

Revenue

The financial performance of Triumeq has been robust, driven by its strong market position and high demand. As a flagship product of ViiV Healthcare, Triumeq contributes significantly to the company's revenue.

Market Share

Triumeq has captured a substantial share of the HIV treatment market, competing with other antiretroviral therapies. Its market share is sustained by its clinical efficacy, patient preference for a single-tablet regimen, and ongoing marketing efforts by ViiV Healthcare.

Competitive Landscape

The HIV treatment market is highly competitive, with several other antiretroviral therapies available. However, Triumeq's unique combination and clinical profile have helped it maintain a strong competitive edge. Other notable competitors include regimens like efavirenz/emtricitabine/tenofovir and newer integrase inhibitors[1].

Future Outlook

Patent Expiry

The patent for dolutegravir, a key component of Triumeq, is set to expire in the coming years, which could lead to the introduction of generic versions. This could significantly impact the pricing and market dynamics of Triumeq, potentially reducing its revenue but increasing accessibility for patients[1].

Emerging Markets

The growing demand for HIV treatments in emerging markets presents an opportunity for Triumeq. ViiV Healthcare's efforts to reduce costs and improve accessibility in these regions could further expand the drug's market reach.

Impact of Regulatory Guidance

The FDA's draft guidance documents provide a framework for the development and approval of generic versions of Triumeq. These guidelines outline the necessary studies and bioequivalence criteria, which will be crucial as generic competitors enter the market[2][3][5].

Conclusion

Triumeq has established a strong presence in the HIV treatment market due to its efficacy, convenience, and robust marketing. However, its high cost and impending patent expiry pose significant challenges. As the market evolves, ViiV Healthcare will need to adapt its pricing strategies and expand its reach into emerging markets to maintain its market position.

Key Takeaways

• Approval and Use: Triumeq was approved in 2014 for the treatment of HIV/AIDS in adults and adolescents.
• Mechanism of Action: The drug combines abacavir, dolutegravir, and lamivudine to inhibit HIV replication.
• Clinical Efficacy: Demonstrated superior viral suppression rates in clinical trials.
• Cost and Accessibility: High cost due to patent status, but efforts are being made to reduce costs in developing countries.
• Financial Performance: Significant revenue contributor for ViiV Healthcare.
• Competitive Landscape: Strong market position but faces competition from other antiretroviral therapies.
• Future Outlook: Patent expiry and generic competition could impact revenue but increase accessibility.

FAQs

What is Triumeq used for?

Triumeq is used for the treatment of HIV/AIDS in adults and adolescents aged 12 years and older.

How does Triumeq work?

Triumeq works by combining three antiretroviral medications: abacavir (a nucleoside analog reverse transcriptase inhibitor), dolutegravir (an integrase inhibitor), and lamivudine (a nucleoside analog reverse transcriptase inhibitor) to inhibit HIV replication.

Why is Triumeq so expensive?

Triumeq is expensive because it is under patent and not yet available as a generic, with a year's supply costing around $33,000.

What are the clinical benefits of Triumeq?

Triumeq has shown superior viral suppression rates compared to other antiretroviral regimens and offers the convenience of a single-tablet regimen.

How will the patent expiry of dolutegravir affect Triumeq?

The patent expiry of dolutegravir could lead to the introduction of generic versions, potentially reducing the revenue of Triumeq but increasing its accessibility for patients.

Sources

1. Wikipedia: Abacavir/dolutegravir/lamivudine
2. FDA: Draft Guidance on Abacavir sulfate; Dolutegravir sodium; Lamivudine
3. FDA: Draft Guidance on Abacavir Sulfate; Dolutegravir Sodium; Lamivudine
4. TGA: AusPAR Triumeq Dolutegravir sodium/abacavir sulfate/lamivudine
5. FDA: Abacavir Sulfate; Dolutegravir Sodium; Lamivudine Oral Tablet