DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE - Generic Drug Details

What are the generic drug sources for doravirine; lamivudine; tenofovir disoproxil fumarate and what is the scope of patent protection?

Doravirine; lamivudine; tenofovir disoproxil fumarate is the generic ingredient in one branded drug marketed by Msd Merck Co and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Doravirine; lamivudine; tenofovir disoproxil fumarate has ninety-seven patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

International Patents:	97
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	13
DailyMed Link:	DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Constraining patent/regulatory exclusivity:

8,486,975

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 DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

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

Sponsor	Phase
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida	N/A
Prism Health North Texas	Phase 3
Merck Sharp & Dohme LLC	Phase 3

See all DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE clinical trials

Pharmacology for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

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 DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

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 DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DELSTRIGO	Tablets	doravirine; lamivudine; tenofovir disoproxil fumarate	100 mg/300 mg/ 300 mg	210807	1	2022-08-30

US Patents and Regulatory Information for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes	10,603,282		Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes	10,842,751		Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes	8,486,975		Y	Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes

International Patents for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Country	Patent Number	Title	Estimated Expiration
Nicaragua	201200146	INHIBIDORES NO NUCLEOSÍDICOS DE LA TRANSCRIPTASA INVERSA
European Patent Office	4424373	COMPOSITIONS PHARMACEUTIQUES CONTENANT DE LA DORAVIRINE, DU FUMARATE DE TÉNOFOVIR DISOPROXIL ET DE LAMIVUDINE (PHARMACEUTICAL COMPOSITIONS CONTAINING DORAVIRINE, TENOFOVIR DISOPROXIL FUMARATE AND LAMIVUDINE)
Slovenia	2552902
Hungary	E031785
Spain	2536295
Brazil	112012024691	composto, e, composição farmacêutica
Ukraine	108495	НЕНУКЛЕОЗИДНІ ІНГІБІТОРИ ЗВОРОТНОЇ ТРАНСКРИПТАЗИ (REVERSE TRANSCRIPTASE NUCLEOSIDE INHIBITORS)

Supplementary Protection Certificates for DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2924034	19C1025	France		PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN COMBINAISON AVEC LE L0181126 AMIVUDINE EN COMBINAISON AVEC LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333 2
2924034	122019000042	Germany		PRODUCT NAME: DORAVIRIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT LAMIVUDIN UND TENOFOVIR-DISOPROXIL-FUMARAT; REGISTRATION NO/DATE: EU/1/18/1333 20181122
2552902	2019/020	Ireland		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/18/1332/001, EU/1/18/1332/002, EU/1/18/1333/001, EU/1/18/1333/002, 20181122
2924034	C201930027	Spain		PRODUCT NAME: DORAVIRINA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA EN COMBINACION CON LAMIVUDINA Y TENOFOVIR DISOPROXILO FUMARATO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1333; DATE OF AUTHORISATION: 20181122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1333; DATE OF FIRST AUTHORISATION IN EEA: 20181122
2552902	19C1024	France		PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/18/1333 20181126
2552902	1990025-7	Sweden		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1333 20181126
2924034	132019000000062	Italy		PRODUCT NAME: DORAVIRINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE IN COMBINAZIONE CON LAMIVUDINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE IN COMBINAZIONE CON TENOFOVIR O UN SUO ESTERE, IN PARTICOLARE UN ESTERE DI DISOPROXIL O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE UN SALE FUMARATO(DELSTRIGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1333/001-002, 20181127

DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Doravirine, Lamivudine, and Tenofovir Disoproxil Fumarate

Introduction to Doravirine, Lamivudine, and Tenofovir Disoproxil Fumarate

Doravirine, in combination with lamivudine and tenofovir disoproxil fumarate, marketed as DELSTRIGO™, and as a single agent as PIFELTRO™, represents a significant advancement in the treatment of HIV-1 infection. This combination therapy has garnered substantial attention due to its efficacy, safety profile, and convenience.

Regulatory Approvals and Market Access

The regulatory approvals for DELSTRIGO™ and PIFELTRO™ have been a crucial factor in their market dynamics. Both drugs received positive opinions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in 2018, and subsequent approvals from the U.S. Food and Drug Administration (FDA)[1][2][4].

These approvals have opened up significant market opportunities, particularly in regions with high HIV prevalence. The drugs are now available in several countries, including the United States, European Union, and Australia, expanding their reach and potential patient base.

Clinical Efficacy and Safety

The clinical efficacy of DELSTRIGO™ and PIFELTRO™ has been well-documented through several Phase 3 trials, including DRIVE-FORWARD, DRIVE-AHEAD, and DRIVE-SHIFT. These studies have shown that doravirine, either as a single agent or in combination with lamivudine and tenofovir disoproxil fumarate, is non-inferior to other antiretroviral therapies in achieving viral suppression[2][3][5].

For instance, the DRIVE-FORWARD trial demonstrated that 73.1% of patients treated with doravirine achieved viral suppression at Week 96, compared to 66.0% treated with ritonavir-boosted darunavir[3].

The safety profile of these drugs is also favorable, with low rates of adverse reactions and discontinuations due to adverse events. In the DRIVE-FORWARD trial, common adverse reactions included nausea, headache, fatigue, diarrhea, and abdominal pain, but no severe reactions occurred in more than 2% of participants[2].

Market Competition

The HIV treatment market is highly competitive, with several established antiretroviral therapies available. However, DELSTRIGO™ and PIFELTRO™ offer unique advantages, such as a once-daily dosing regimen, a favorable lipid profile, and a lower pill burden, which can enhance patient adherence and quality of life.

Competitive Landscape

• Other Antiretroviral Therapies: Drugs like efavirenz, darunavir, and emtricitabine/tenofovir disoproxil fumarate are well-established in the market. However, doravirine's profile, particularly its non-inferior efficacy and better lipid profile, positions it as a competitive option[2][3].
• New Entrants: The continuous development of new antiretroviral agents means that the market is dynamic, with new treatments potentially challenging the market share of existing drugs.

Financial Trajectory

Revenue Potential

The approval and launch of DELSTRIGO™ and PIFELTRO™ have contributed significantly to Merck's revenue. The drugs' unique selling points, such as their efficacy and safety, have helped in capturing a substantial share of the HIV treatment market.

Pricing Strategy

The pricing of these drugs is a critical factor in their financial trajectory. While the exact pricing varies by region, the drugs are generally priced competitively with other antiretroviral therapies. The cost-effectiveness, considering the reduced need for additional medications and the convenience of a once-daily regimen, can also influence prescribing decisions and patient adherence.

Market Expansion

Merck's commitment to expanding access to these drugs in various regions, including low- and middle-income countries, is expected to further boost revenue. Partnerships with global health organizations and governments can facilitate this expansion.

Impact on Patient Care and Public Health

Improved Adherence

The once-daily dosing regimen and the favorable safety profile of DELSTRIGO™ and PIFELTRO™ can significantly improve patient adherence, which is a critical factor in the effective management of HIV.

Public Health Benefits

By providing effective and safe treatment options, these drugs contribute to the overall public health goal of reducing HIV transmission and improving the quality of life for people living with HIV.

Future Outlook

Ongoing Research and Development

Merck continues to invest in research and development to further enhance the clinical profile of doravirine. Ongoing and future trials will focus on expanding the use of these drugs to different patient populations, such as those with transmitted resistance to NNRTIs and those switching from other antiretroviral regimens due to intolerability[3].

Market Growth

The HIV treatment market is expected to grow, driven by increasing awareness, improved diagnostic tools, and the need for effective and safe treatments. DELSTRIGO™ and PIFELTRO™ are well-positioned to capture a significant share of this growing market.

Key Takeaways

• Regulatory Approvals: Positive opinions and approvals from major regulatory bodies have facilitated market access.
• Clinical Efficacy: Non-inferior efficacy and favorable safety profiles compared to existing antiretroviral therapies.
• Market Competition: Unique selling points such as once-daily dosing and better lipid profiles.
• Financial Trajectory: Significant revenue potential driven by competitive pricing and market expansion.
• Public Health Impact: Improved patient adherence and overall public health benefits.

FAQs

1. What are the key components of DELSTRIGO™?

DELSTRIGO™ is a once-daily fixed-dose combination tablet containing doravirine (100 mg), lamivudine (300 mg), and tenofovir disoproxil fumarate (300 mg)[2].

2. How does doravirine compare to other antiretroviral therapies?

Doravirine has been shown to be non-inferior to other antiretroviral therapies in achieving viral suppression, with a favorable lipid profile and low rates of adverse reactions[2][3].

3. What are the common adverse reactions associated with DELSTRIGO™ and PIFELTRO™?

Common adverse reactions include nausea, headache, fatigue, diarrhea, and abdominal pain, but severe reactions are rare[2].

4. How does the pricing of DELSTRIGO™ and PIFELTRO™ compare to other HIV treatments?

The pricing is generally competitive with other antiretroviral therapies, considering the cost-effectiveness of a once-daily regimen and reduced need for additional medications.

5. What is the future outlook for DELSTRIGO™ and PIFELTRO™ in the HIV treatment market?

The future outlook is positive, with ongoing research and development aimed at expanding the use of these drugs to different patient populations and continued market growth driven by increasing demand for effective and safe HIV treatments.

Cited Sources:

1. Merck Receives Positive CHMP Opinion for DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) and PIFELTRO™ (doravirine) in the European Union for the Treatment of HIV-1 Infection. Merck.
2. Merck's PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive US FDA Approval for Use in Appropriate Adults Living with HIV-1. Merck.
3. Merck Announces Week 96 Data from Pivotal Phase 3 DRIVE-FORWARD Study of Its Investigational HIV Therapy Doravirine. Merck.
4. auspar-doravirine-doravirine-lamivudine-tenofovir-disoproxil-fumarate. Therapeutic Goods Administration.
5. Merck's HIV Therapy DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate) Meets Primary Efficacy Endpoint in Phase 3 DRIVE-SHIFT Study Evaluating Switch to DELSTRIGO from Other Antiretroviral Treatment Regimens. Merck.