DORAVIRINE - Generic Drug Details

What are the generic drug sources for doravirine and what is the scope of freedom to operate?

Doravirine is the generic ingredient in two branded drugs marketed by Msd Merck Co and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Doravirine has seventy-three patent family members in forty-four countries.

Two suppliers are listed for this compound.

Summary for DORAVIRINE

International Patents:	73
US Patents:	3
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	51
Patent Applications:	482
Drug Prices:	Drug price trends for DORAVIRINE
What excipients (inactive ingredients) are in DORAVIRINE?	DORAVIRINE excipients list
DailyMed Link:	DORAVIRINE at DailyMed

See drug prices for DORAVIRINE

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

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

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

Sponsor	Phase
Insel Gruppe AG, University Hospital Bern	Phase 4
University of Bern	Phase 4
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland	Phase 4

See all DORAVIRINE clinical trials

Pharmacology for DORAVIRINE

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DORAVIRINE

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for DORAVIRINE

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	PIFELTRO	doravirine	TABLET;ORAL	210806-001	Aug 30, 2018		RX	Yes	Yes
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes			Y
Msd Merck Co	PIFELTRO	doravirine	TABLET;ORAL	210806-001	Aug 30, 2018		RX	Yes	Yes			Y	Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes			Y
Msd Merck Co	DELSTRIGO	doravirine; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210807-001	Aug 30, 2018		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for DORAVIRINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Pifeltro	doravirine	EMEA/H/C/004747 Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class.	Authorised	no	no	no	2018-11-22

International Patents for DORAVIRINE

Country	Patent Number	Title	Estimated Expiration
Brazil	112012024691	composto, e, composição farmacêutica
Norway	2019019
World Intellectual Property Organization (WIPO)	2011120133
Montenegro	02181	NE-NUKLEOZIDNI INHIBITORI REVERZNE TRANSKRIPTAZE (NON-NUCLEOSIDE REVERSE TRANSCRIPT ASE INHIBITORS)
Netherlands	300980
Honduras	2012002039	INHIBIDORES NO NUCLEOSIDICOS DE LA TRANSCRIPTASA INVERSA

Supplementary Protection Certificates for DORAVIRINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2552902	C20190024 00304	Estonia		PRODUCT NAME: DORAVIRIIN;REG NO/DATE: EU/1/18/1332 27.11.2018
2924034	CR 2019 00024	Denmark		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND IN COMBINATION WITH TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126
2924034	SPC/GB19/024	United Kingdom		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL; REGISTERED: UK EU/1/18/1333/001-002 20181122; UK PLGB 5305/0015 20181122
2924034	CA 2019 00024	Denmark		PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126
2924034	25/2019	Austria		PRODUCT NAME: DORAVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON IN KOMBINATION MIT LAMIVUDIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON IN KOMBINATION MIT TENOFOVIR ODER EINEM ESTER DAVON, INSBESONDERE EINEM DISOPROXILESTER ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON, INSBESONDERE EINEM FUMARATSALZ; REGISTRATION NO/DATE: EU/1/18/1333/001-002 (MITTEILUNG) 20181126

Market Dynamics and Financial Trajectory for Doravirine

Introduction to Doravirine

Doravirine, marketed as PIFELTRO, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Merck for the treatment of HIV-1 infection. It has been a significant addition to the antiretroviral therapy (ART) landscape, offering a new treatment option for patients.

Clinical Efficacy and Safety

The efficacy and safety of doravirine have been extensively evaluated in several clinical trials. The Phase 3 DRIVE-FORWARD study demonstrated that doravirine, in combination with other antiretroviral agents, achieved viral suppression in 73.1% of treatment-naïve patients at Week 96, compared to 66.0% for the ritonavir-boosted darunavir group[2].

Market Approval and Adoption

Doravirine was approved by regulatory authorities in 2018 for the treatment of adults with HIV-1 infection, both as a single agent (PIFELTRO) and as a component of a single-tablet regimen (DELSTRIGO; DOR/3TC/TDF)[4].

Market Dynamics

Growth Drivers

The US HIV drug market, where doravirine is a key player, is experiencing significant growth driven by several factors:

• High Success Rate of Antiretrovirals: The success rate associated with available antiretrovirals, including doravirine, is expanding at historic levels, boosting market growth[1].
• Novel Product Launches: The pipeline for HIV drugs is robust, with new products like doravirine contributing to market expansion[1].
• Increased Patient Centric Approaches: Bio-pharmaceutical companies are adopting patient-centric strategies, which are driving market growth and improving healthcare outcomes for HIV patients[1].

Market Size and Forecast

The US HIV drug market is projected to exceed billions of dollars in the coming years, with a high compound annual growth rate (CAGR). This growth is fueled by increased spending on HIV treatments and the high uptake of novel products like doravirine[1].

Financial Trajectory

Revenue and Spending

The net manufacturer revenue generated by the HIV drug market, including doravirine, is expected to grow significantly. The total invoice spending for HIV treatments is also increasing at a high CAGR, contributing to the overall market growth[1].

Competitive Landscape

Merck, the developer of doravirine, is a major player in the HIV treatment market. The company's commitment to advancing innovative science and addressing unmet patient needs has positioned doravirine as a competitive option in the market[2][4].

Patient Access and Affordability

Merck has implemented various strategies to improve patient access to doravirine, particularly in low- and middle-income countries. This includes collaborations with other organizations and the implementation of patient assistance programs to ensure affordability and accessibility of the drug[3].

Ongoing Research and Development

Combination Therapies

Merck is continuing to evaluate doravirine in combination with other antiretrovirals, such as islatravir, in Phase 3 trials. The DOR/ISL combination has shown promising results, with efficacy comparable to commonly used three-drug regimens[4].

Future Prospects

The ongoing research and development activities around doravirine, including its use in diverse populations and different treatment regimens, are expected to further solidify its position in the market and contribute to the overall growth of the HIV treatment sector[4].

Safety and Tolerability

The safety and tolerability profile of doravirine has been consistent with previous studies. Adverse events leading to discontinuation of the study medication were relatively low, indicating a favorable safety profile[2][4].

Conclusion

Doravirine has emerged as a significant player in the HIV treatment market, driven by its clinical efficacy, safety, and the robust market dynamics of the US HIV drug sector. As the market continues to grow, driven by novel product launches and increased patient-centric approaches, doravirine is poised to remain a key treatment option for patients with HIV-1 infection.

Key Takeaways

• Clinical Efficacy: Doravirine has demonstrated high viral suppression rates in clinical trials.
• Market Approval: Approved in 2018 as a single agent and part of a single-tablet regimen.
• Market Growth: The US HIV drug market is growing significantly, driven by novel product launches and patient-centric approaches.
• Financial Trajectory: Expected to contribute to the high CAGR of the US HIV drug market.
• Patient Access: Merck is working to improve access and affordability, especially in low- and middle-income countries.
• Ongoing Research: Continued evaluation in combination therapies and diverse populations.

FAQs

Q1: What is doravirine, and how is it used in HIV treatment? Doravirine, marketed as PIFELTRO, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in combination with other antiretroviral agents to treat HIV-1 infection in adults.

Q2: What were the key findings of the DRIVE-FORWARD study on doravirine? The DRIVE-FORWARD study showed that doravirine achieved viral suppression in 73.1% of treatment-naïve patients at Week 96, compared to 66.0% for the ritonavir-boosted darunavir group[2].

Q3: How is doravirine contributing to the growth of the US HIV drug market? Doravirine is one of the novel products driving the growth of the US HIV drug market through its high success rate and increased patient uptake, contributing to the market's high CAGR[1].

Q4: What strategies is Merck implementing to improve patient access to doravirine? Merck is implementing patient assistance programs and collaborating with other organizations to improve access and affordability of doravirine, especially in low- and middle-income countries[3].

Q5: What are the ongoing research and development activities around doravirine? Merck is evaluating doravirine in combination with other antiretrovirals, such as islatravir, in Phase 3 trials, and continuing to study its efficacy in diverse populations[4].

Sources

1. United States HIV Infection Drug Market Report 2021-2026 - ResearchAndMarkets.com
2. Merck Announces Week 96 Data from Pivotal Phase 3 DRIVE-FORWARD Study of Its Investigational HIV Therapy Doravirine - Merck
3. Environmental, Social & Governance (ESG) Progress Report 2020 - Merck
4. Merck Announces Positive Top-Line Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily Oral Fixed Dose Combination of Doravirine/Islatravir for the Treatment of People with HIV-1 Infection - Merck