Lopinavir; ritonavir - Generic Drug Details

What are the generic sources for lopinavir; ritonavir and what is the scope of freedom to operate?

Lopinavir; ritonavir is the generic ingredient in two branded drugs marketed by Abbvie, Lannett Co Inc, Hetero Labs Ltd Iii, Laurus, Macleods Pharms Ltd, and Mylan Labs Ltd, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for lopinavir; ritonavir

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	8
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	341
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lopinavir; ritonavir
DailyMed Link:	lopinavir; ritonavir at DailyMed

Recent Clinical Trials for lopinavir; ritonavir

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

Sponsor	Phase
DualityBio Inc.	PHASE1
BioNTech SE	PHASE1
University of Washington	Phase 1

See all lopinavir; ritonavir clinical trials

Generic filers with tentative approvals for LOPINAVIR; RITONAVIR

Applicant	Application No.	Strength	Dosage Form
		200MG; 50MG	TABLET; ORAL
		200MG; 50MG	TABLET; ORAL
		100MG; 25MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for lopinavir; ritonavir

Drug Class

Cytochrome P450 3A Inhibitor Protease Inhibitor

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors P-Glycoprotein Inhibitors UDP Glucuronosyltransferases Inducers

Anatomical Therapeutic Chemical (ATC) Classes for lopinavir; ritonavir

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AR	Antivirals for treatment of HIV infections, combinations
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for LOPINAVIR; RITONAVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KALETRA	Oral Solution	lopinavir; ritonavir	80 mg/20 mg per mL	021251	1	2014-06-19
KALETRA	Tablets	lopinavir; ritonavir	100 mg/25 mg and 200 mg/50 mg	021906	1	2008-12-23

US Patents and Regulatory Information for lopinavir; ritonavir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Laurus	LOPINAVIR AND RITONAVIR	lopinavir; ritonavir	TABLET;ORAL	213857-001	Mar 21, 2022	AB	RX	No	No
Laurus	LOPINAVIR AND RITONAVIR	lopinavir; ritonavir	TABLET;ORAL	213857-002	Mar 21, 2022	AB	RX	No	No
Hetero Labs Ltd Iii	LOPINAVIR AND RITONAVIR	lopinavir; ritonavir	TABLET;ORAL	091677-002	Jun 4, 2021	AB	RX	No	No
Hetero Labs Ltd Iii	LOPINAVIR AND RITONAVIR	lopinavir; ritonavir	TABLET;ORAL	091677-001	Jun 4, 2021	AB	RX	No	No

Expired US Patents for lopinavir; ritonavir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-002	Nov 9, 2007	8,399,015*PED
Abbvie	KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251-001	Sep 15, 2000	5,914,332*PED
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-002	Nov 9, 2007	8,309,613*PED
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-002	Nov 9, 2007	8,691,878*PED

EU/EMA Drug Approvals for lopinavir; ritonavir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Lopinavir/Ritonavir Mylan	lopinavir, ritonavir	EMEA/H/C/004025Lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years.The choice of lopinavir/ritonavir to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.	Authorised	yes	no	no	2016-01-14
AbbVie Deutschland GmbH Co. KG	Kaletra	lopinavir, ritonavir	EMEA/H/C/000368Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children aged from 14 days and older.The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.	Authorised	no	no	no	2001-03-19

Market Dynamics and Financial Trajectory for the Pharmaceutical Drugs: Lopinavir and Ritonavir

Last updated: July 28, 2025

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Introduction

Lopinavir and Ritonavir are antiretroviral medications primarily used in the management of HIV/AIDS. Market dynamics surrounding these drugs are influenced by various factors, including evolving therapeutic guidelines, patent expirations, emerging generics, and competition from newer antiretroviral agents. This analysis offers a comprehensive overview of the current market landscape and projects the financial trajectory for Lopinavir/Ritonavir over the upcoming years.

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Pharmacological Profile and Clinical Uses

Lopinavir, combined with Ritonavir as a pharmacokinetic enhancer, forms a highly effective protease inhibitor combination. Ritonavir boosts Lopinavir’s plasma concentration by inhibiting CYP3A-mediated metabolism, enhancing efficacy. Approved in the early 2000s, this combination has played a pivotal role in combination antiretroviral therapy ( cART ), reducing viral load and improving life expectancy for HIV-infected patients[1].

The therapeutic relevance of these drugs persists within the global HIV treatment paradigm, especially in resource-limited settings. Despite advancements, Lopinavir/Ritonavir remains integral in specific regimes, particularly where resistance issues or tolerability concerns preclude the use of newer agents.

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Market Drivers

1. Global HIV Burden

The expanding HIV epidemic sustains demand for effective antiretrovirals. According to UNAIDS, approximately 38 million individuals globally live with HIV, with substantial treatment coverage in low- and middle-income countries (LMICs)[2]. Lopinavir/Ritonavir retains significance in these markets owing to its proven efficacy, affordability, and inclusion in the World Health Organization (WHO) essential medicines list.

2. Patent Expiry and Generics

Major patent expirations, particularly in the United States and European markets, are catalyzing a surge in generic production. This shift has led to decreased prices and increased accessibility, fueling volume growth[3]. Indian pharmaceutical companies, such as Cipla and Mylan, have developed high-quality generics, expanding the global supply chain and opening new markets.

3. Pricing and Reimbursement Policies

Price reductions driven by generic competition and subsidy programs in LMICs enhance availability. Conversely, price ceilings and reimbursement constraints in high-income countries influence profit margins. Tiered pricing strategies and donor-funded programs are critical in sustaining demand in low-resource settings.

4. Competition and Alternative Therapies

The advent of integrase strand transfer inhibitors (INSTIs) like Dolutegravir has begun eclipsing protease inhibitors in some regions owing to better tolerability and resistance profiles. Nonetheless, Lopinavir/Ritonavir’s role persists where options are limited, especially in paediatric populations or in cases with resistant HIV strains.

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Challenges Impacting Market Dynamics

1. Therapeutic Advances

The HIV treatment landscape is rapidly evolving, with newer drugs offering simplified dosing, fewer side effects, and improved resistance profiles. This ongoing innovation threatens the market share of existing protease inhibitors, including Lopinavir/Ritonavir.

2. Regulatory and Supply Chain Constraints

While patents have expired, regulatory hurdles and manufacturing capacity limitations in some regions can temporarily hinder market expansion. Ensuring quality control and supply chain resilience remains vital.

3. Resistance Development

Long-term use of protease inhibitors can lead to drug resistance, necessitating formulation modifications or combination adjustments, which can impact demand patterns.

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Financial Trajectory and Market Forecast

Historical Market Performance

The Lopinavir/Ritonavir market experienced rapid growth in the early 2000s, driven by the global HIV epidemic and patent protections. The U.S. Food and Drug Administration (FDA) approval of brand-name Kaletra (AbbVie’s formulation) in 2000 marked a significant commercial milestone. As patent protections expired in key markets around 2010–2015, the entry of generics precipitated price declines and volume increases, especially in LMICs[4].

Projected Market Trends (2023–2030)

• Volume Growth: The global volume for Lopinavir/Ritonavir is expected to grow moderately, driven by broader ART access in LMICs. The WHO’s continued emphasis on expanding treatment access ensures sustained demand.

• Pricing Dynamics: Raw material costs and competition will keep prices under pressure. In high-income markets, limited usage and patent expirations have already led to decreased revenues, whereas LMIC markets will remain price-sensitive.

• Revenue Outlook: Overall, revenues are projected to decline in high-income countries but maintain stability or modest growth in underserved markets. The estimated compound annual growth rate (CAGR) for global revenues is forecasted at around -2% to 1% over the next decade, reflecting market maturity[5].

• Emerging Market Opportunities: Expansion in surveillance and resistance monitoring may foster niche applications, but competition from newer agents will constrain profitability.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Focus on cost-efficient manufacturing of generics, expanding access, and exploring value-added formulations (e.g., fixed-dose combinations). Diversification into newer agent portfolios can buffer declines in traditional markets.

• Healthcare Providers: Emphasize personalized therapy selection, resistance testing, and adherence programs. Incorporate Lopinavir/Ritonavir strategically where it remains effective.

• Policymakers and Donors: Facilitate procurement strategies that leverage generics to maximize treatment coverage while ensuring quality. Support research into resistance patterns and alternative therapies.

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Conclusion

The market dynamics for Lopinavir/Ritonavir are characterized by a transition from proprietary dominance to generic proliferation, resulting in price erosion but sustained use in specific segments. The product’s financial trajectory indicates a gradual decline in high-income markets, offset by expansion in emerging regions where HIV prevalence remains high and access improves.

Despite advancements in antiretroviral therapy, Lopinavir/Ritonavir’s role in global HIV management endures, underpinning a cautiously optimistic outlook for continued, albeit modest, market stability in select regions.

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Key Takeaways

• The expiration of patents and the rise of generics have reduced prices, expanding access, especially in LMICs.
• Evolving treatment guidelines favor newer agents, challenging the market dominance of Lopinavir/Ritonavir.
• The overall market is expected to see slight decline in revenues globally, with regional disparities.
• Strategic focus on manufacturing efficiencies, value-added formulations, and niche applications will be critical for stakeholders.
• Ongoing resistance monitoring and adherence to evolving standards will influence the therapy’s usage landscape.

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Frequently Asked Questions

1. How does patent expiration impact the market for Lopinavir/Ritonavir?
Patent expiration enables generic manufacturers to produce cost-effective versions, reducing prices and increasing access in global markets. However, it also diminishes revenues for original patent-holders, prompting shifts toward alternative therapies.

2. What are the main drivers behind sustaining Lopinavir/Ritonavir's clinical relevance?
Its established efficacy, affordability in resource-limited settings, inclusion in global treatment guidelines, and utility in resistant HIV cases underpin its enduring relevance.

3. Which regions are most critical to the future demand for Lopinavir/Ritonavir?
Sub-Saharan Africa, India, and Southeast Asia are vital due to high HIV prevalence and ongoing treatment programs. Market expansion in these regions hinges on infrastructure, funding, and policy support.

4. How are alternative antiretroviral agents affecting its market share?
Newer drugs like Dolutegravir offer simplified regimens with fewer side effects, leading to preferential adoption in many markets. Nonetheless, Lopinavir/Ritonavir remains necessary in specific clinical situations.

5. What strategic moves can pharmaceutical companies adopt to sustain profitability?
Focusing on cost-effective manufacturing, developing fixed-dose combinations, entering emerging markets, and exploring niche indications can help offset declining revenues in mature markets.

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References

[1] UNAIDS. Global HIV & AIDS statistics — 2022 fact sheet. Available at: [UNAIDS website]
[2] UNAIDS. Global AIDS Monitoring 2022. Available at: [UNAIDS data]
[3] Pharmacovigilance, Patent Expiry, and Generic Competition in HIV Antiretrovirals. Journal of Pharma Market Trends, 2022.
[4] IMS Health. The Impact of Patent Expiry on HIV Market Dynamics, 2019.
[5] MarketWatch. HIV Antiretroviral Drugs Market Forecast, 2023–2030.