LAMIVUDINE; RALTEGRAVIR POTASSIUM - Generic Drug Details

What are the generic drug sources for lamivudine; raltegravir potassium and what is the scope of freedom to operate?

Lamivudine; raltegravir potassium is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lamivudine; raltegravir potassium has ninety-five patent family members in forty-three countries.

Summary for LAMIVUDINE; RALTEGRAVIR POTASSIUM

International Patents:	95
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	1
DailyMed Link:	LAMIVUDINE; RALTEGRAVIR POTASSIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LAMIVUDINE; RALTEGRAVIR POTASSIUM

Constraining patent/regulatory exclusivity:

7,754,731*PED

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 LAMIVUDINE; RALTEGRAVIR POTASSIUM

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

Sponsor	Phase
St. James's Hospital, Ireland	Phase 4

See all LAMIVUDINE; RALTEGRAVIR POTASSIUM clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LAMIVUDINE; RALTEGRAVIR POTASSIUM

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

US Patents and Regulatory Information for LAMIVUDINE; RALTEGRAVIR POTASSIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015		DISCN	No	No	7,754,731*PED				Y
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015		DISCN	No	No	7,169,780*PED

Expired US Patents for LAMIVUDINE; RALTEGRAVIR POTASSIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015	7,169,780*PED
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015	7,820,660
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015	7,435,734*PED
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015	7,217,713*PED

EU/EMA Drug Approvals for LAMIVUDINE; RALTEGRAVIR POTASSIUM

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp Dohme Limited	Dutrebis	lamivudine, raltegravir potassium	EMEA/H/C/003823 Dutrebis is indicated in combination with other anti‑retroviral medicinal products for the treatment of human immunodeficiency virus (HIV‑1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes (see sections 4.2, 4.4 and 5.1).	Withdrawn	no	no	no	2015-03-26

International Patents for LAMIVUDINE; RALTEGRAVIR POTASSIUM

Country	Patent Number	Title	Estimated Expiration
Norway	20073404
Israel	183614	ANHYDROUS CRYSTALLINE POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR
Brazil	PI0518760	sal de potÁssio do composto, e, composiÇço farmacÊutica
Argentina	101429	SAL POTÁSICA DE UN INHIBIDOR DE LA INTEGRASA DE VIH
Malaysia	144320	POTASSIUM SALT OF AN HIV INTEGRASE INHIBITOR
Taiwan	200631944	Potassium salt of an HIV integrase inhibitor

Supplementary Protection Certificates for LAMIVUDINE; RALTEGRAVIR POTASSIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	30/2008	Austria		PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ; REGISTRATION NO/DATE: EU/1/07/436 (MITTEILUNG) 20071220
1441735	DO 67; 3-2008	Slovakia		PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: Registration in Community EU/1/07/436/001-002 20071220; FORMER OWNER: ISTITUTO DI RICERCHE DI BIOLOGIA MOLECOLARE P. ANGELETTI SPA. IT
1441735	C20080001 00016	Estonia		PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801
1441735	300340	Netherlands		PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20080102
1441735	PA2008 007, C1441735	Lithuania		PRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1441735	67 3-2008	Slovakia		PRODUCT NAME: RALTEGRAVIR; REGISTRATION NO/DATE: EU/1/07/436/001 - EU/1/07/436/002 20080102

LAMIVUDINE; RALTEGRAVIR POTASSIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Lamivudine and Raltegravir Potassium

Introduction to Lamivudine and Raltegravir Potassium

Lamivudine and raltegravir potassium are two crucial antiviral drugs used in the treatment of HIV and hepatitis B. Understanding their market dynamics and financial trajectories is essential for pharmaceutical companies, investors, and healthcare policymakers.

Market Size and Growth Projections for Lamivudine

Current Market Size

The lamivudine market was valued at USD 1.2 billion in 2023 and is projected to reach USD 2.1 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7.2% from 2024 to 2031[1].

Drivers of Market Growth

The growth of the lamivudine market is driven by several key factors:

• Increasing Incidence of HIV and Hepatitis B: The rising global incidence of these diseases increases the demand for effective antiviral therapies like lamivudine[1][3].
• Advancements in Drug Formulations: Improvements in medication formulations, such as better tablets, capsules, and oral solutions, enhance patient adherence and outcomes[1][3].
• Supportive Government Policies: Policies aimed at expanding access to HIV and hepatitis B treatments globally contribute to market growth[1][3].
• Rising Healthcare Expenditure: Increased healthcare spending in various regions fuels the demand for lamivudine[3].

Market Segmentation for Lamivudine

By Application

The lamivudine market is segmented into lamivudine tablets, capsules, and oral solutions. Each formulation type has its own market share and growth prospects[1].

By Product

Lamivudine is used primarily for HIV treatment, hepatitis B treatment, and as part of antiviral therapy. These segments are critical in understanding the diverse applications of the drug[1].

Geographical Regions

The market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own market dynamics and growth potential[1].

Market Dynamics for Raltegravir Potassium

Clinical Use and Efficacy

Raltegravir potassium, an integrase inhibitor, has shown high efficacy in treating HIV, particularly in therapy-naive patients and those with virological failure. It is known for its good tolerability and favorable safety profile[2].

Market Drivers

• High Efficacy in HIV Treatment: Raltegravir's ability to achieve high levels of virological suppression makes it a preferred choice in antiretroviral therapy[2].
• Combination Therapy: Its use in combination with other antiretroviral drugs enhances treatment outcomes and patient adherence[2][4].
• Research and Development: Ongoing research into its potential applications in other viral infections and its incorporation into new treatment regimens drives market interest[2].

Financial Trajectory for Lamivudine

Revenue Projections

The lamivudine market is expected to grow significantly, reaching USD 2.1 billion by 2031. This growth is fueled by increasing demand and advancements in drug formulations[1].

Key Players and Market Share

Companies like Gilead Sciences, GlaxoSmithKline, Bristol-Myers Squibb, and others play a significant role in the lamivudine market. Their market share and competitive strategies are crucial in shaping the financial trajectory of the drug[1][3].

Financial Trajectory for Raltegravir Potassium

Market Impact

Raltegravir potassium, as part of the integrase inhibitor class, contributes to the overall antiretroviral drug market. Its financial impact is significant due to its high efficacy and widespread use in HIV treatment regimens[2].

Pricing and Cost Considerations

The cost of raltegravir potassium can be a factor in its market dynamics. However, its inclusion in combination therapies and its effectiveness often justify the costs, making it a valuable component of antiretroviral treatment plans[2][4].

Challenges and Restraints

Drug Resistance

Both lamivudine and raltegravir potassium face challenges related to drug resistance. The development of resistance can reduce the efficacy of these drugs and impact their market growth[1][3].

Regulatory Framework

Stringent regulatory requirements can pose challenges for the approval and distribution of these drugs. Compliance with these regulations is essential for maintaining market presence[3].

Generic Competition

The increasing availability of generic versions of lamivudine and other antiviral drugs can reduce the market share of branded products, affecting their financial trajectory[3].

Opportunities and Future Prospects

Leveraging Biosimilars and Generics

The use of biosimilars and generics can reduce costs and expand access to these drugs, particularly in emerging markets. This presents an opportunity for market growth and increased patient access[3].

Telemedicine and Online Pharmacies

The expansion of telemedicine and online pharmacy services can widen the distribution networks for lamivudine and raltegravir potassium, making them more accessible to a broader patient population[3].

Research and Development

Continuous research into new applications and formulations of these drugs can enhance their market presence and financial performance. Innovations in treatment regimens and combination therapies are key to future growth[1][2].

Competitive Landscape

Key Companies

Companies such as Gilead Sciences, GlaxoSmithKline, Bristol-Myers Squibb, and others are major players in the market for lamivudine and raltegravir potassium. Their competitive strategies, product portfolios, and research efforts shape the market dynamics[1][3].

Porter’s Five Forces Analysis

This analysis helps in understanding the competitive position of businesses in the lamivudine market. It identifies the strength of current competitive positions and potential repositioning opportunities, highlighting areas of strength, weakness, and potential threats[3].

Conclusion

The market dynamics and financial trajectories of lamivudine and raltegravir potassium are influenced by a combination of factors including increasing disease incidence, advancements in drug formulations, supportive government policies, and ongoing research. While challenges such as drug resistance and regulatory hurdles exist, opportunities in leveraging biosimilars, expanding distribution networks, and continuous innovation offer promising avenues for growth.

Key Takeaways

• Growing Market Size: The lamivudine market is projected to reach USD 2.1 billion by 2031, driven by increasing demand and advancements in drug formulations.
• High Efficacy: Raltegravir potassium has shown high efficacy in HIV treatment, making it a preferred choice in antiretroviral therapy.
• Challenges and Opportunities: Drug resistance, regulatory frameworks, and generic competition pose challenges, while biosimilars, telemedicine, and ongoing research offer opportunities for growth.
• Competitive Landscape: Major pharmaceutical companies play a significant role in shaping the market dynamics through their competitive strategies and research efforts.

FAQs

Q1: What is the current market size of the lamivudine market?

The lamivudine market was valued at USD 1.2 billion in 2023[1].

Q2: What are the primary drivers of the lamivudine market growth?

The primary drivers include the increasing incidence of HIV and hepatitis B, advancements in drug formulations, and supportive government policies[1][3].

Q3: How effective is raltegravir potassium in HIV treatment?

Raltegravir potassium has shown high efficacy in achieving virological suppression, particularly in therapy-naive patients and those with virological failure[2].

Q4: What are the challenges faced by the lamivudine and raltegravir potassium markets?

Challenges include drug resistance, stringent regulatory requirements, and increased generic competition[1][3].

Q5: What opportunities exist for the growth of the lamivudine and raltegravir potassium markets?

Opportunities include leveraging biosimilars and generics, expanding distribution through telemedicine and online pharmacies, and continuous research into new applications and formulations[3].

Sources

1. Market Research Intellect - Lamivudine Market Size, Share | Industry Research Report 2031
2. PLOS ONE - Clinical Use of HIV Integrase Inhibitors: A Systematic Review and Meta-Analysis
3. 360iResearch - Lamivudine Drugs Market Size & Share 2025-2030
4. JAMA Network - Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults and Adolescents
5. Unitaid - End-of-project-evaluation-of-the-chai-paediatric-hiv-aids-and-innovation-in-paediatric-market-access-ipma-projects