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:	340
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
University of Washington	Phase 1
University of Wisconsin, Madison	Phase 1
Wisconsin Partnership Program	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
Abbvie	KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251-001	Sep 15, 2000	AA	RX	Yes	Yes
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-002	Nov 9, 2007	AB	RX	Yes	No
Laurus	LOPINAVIR AND RITONAVIR	lopinavir; ritonavir	TABLET;ORAL	213857-001	Mar 21, 2022	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
Abbvie	KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251-001	Sep 15, 2000
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-001	Oct 28, 2005

EU/EMA Drug Approvals for LOPINAVIR; RITONAVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH Co. KG	Kaletra	lopinavir, ritonavir	EMEA/H/C/000368 Kaletra 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
Mylan Pharmaceuticals Limited	Lopinavir/Ritonavir Mylan	lopinavir, ritonavir	EMEA/H/C/004025 Lopinavir/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

Market Dynamics and Financial Trajectory for Lopinavir/Ritonavir

Introduction

Lopinavir and ritonavir, commonly known as Kaletra, are potent antiviral medications that belong to the class of protease inhibitors. These drugs are primarily used in the treatment of HIV/AIDS and have also been explored for their potential in treating other conditions such as COVID-19. Here, we delve into the market dynamics and financial trajectory of lopinavir/ritonavir.

Global Market Overview

The global lopinavir/ritonavir market is anticipated to experience significant growth over the forecast period of 2021 to 2028. According to Data Bridge Market Research, the market is expected to grow at a CAGR of 5% during this period. This growth is driven by several factors, including the rising prevalence of HIV/AIDS, increasing government initiatives, advancements in treatment options, and growing awareness about the disease[1].

Market Segmentation

The lopinavir/ritonavir market is segmented based on type, dosage, route of administration, application, demographic, end-users, and distribution channels. The market is dominated by the antiretroviral and protease inhibitor segments. The oral route of administration is the most common, and the market is primarily driven by the treatment of HIV-1. The end-users include clinics, hospitals, and other healthcare facilities, with hospital pharmacies and retail pharmacies being the main distribution channels[1].

Regional Market Analysis

North America currently dominates the lopinavir/ritonavir market due to the presence of major pharmaceutical companies, a well-developed healthcare sector, and increasing awareness about HIV/AIDS. However, the Asia-Pacific and European regions are also expected to show significant growth due to increasing research and development activities, growing awareness, and rising investments in the healthcare sector[1].

India Market Specifics

In India, the lopinavir/ritonavir market was valued at USD 100.21 million in 2023 and is projected to reach USD 133.38 million by 2030, growing at a CAGR of 5.08%. The demand for these drugs is driven by the rising prevalence of HIV/AIDS, increased investments in infrastructure development, and growing government initiatives. The western region of India is the largest market for these medications[4].

Key Drivers

• Rising Prevalence of HIV/AIDS: The increasing number of HIV/AIDS cases globally is a major driver for the lopinavir/ritonavir market.
• Government Initiatives: Government support and initiatives to improve access to HIV treatment are boosting the market.
• Advancements in Treatment: Continuous research and development in antiretroviral therapies are expanding treatment options.
• Growing Awareness: Increasing awareness about HIV/AIDS and the importance of antiretroviral therapy is driving market growth[1][4].

Challenges

• High Cost of Treatment: The high cost of lopinavir/ritonavir is a significant barrier, especially in developing countries.
• Adverse Reactions: Common adverse reactions such as diarrhea, nausea, vomiting, hypertriglyceridemia, and hypercholesterolemia can hamper market growth.
• Lack of Awareness: Limited awareness in some regions about the availability and benefits of these medications can also impede market expansion[1][4].

Financial Trajectory

The financial trajectory of lopinavir/ritonavir is positive, with steady growth anticipated over the coming years. Here are some key financial insights:

• Cost-Effectiveness: Studies have shown that lopinavir/ritonavir can be cost-effective in the long term. For instance, a model estimated that lopinavir/ritonavir could save $3,461 per patient in total HIV care costs over five years compared to nelfinavir[3].
• Market Size: The India lopinavir/ritonavir market alone is expected to grow from USD 100.21 million in 2023 to USD 133.38 million by 2030[4].
• Revenue Growth: The global market is expected to grow at a CAGR of 5%, indicating a steady increase in revenue for pharmaceutical companies involved in the production and distribution of these drugs[1].

Competitive Landscape

The competitive landscape of the lopinavir/ritonavir market includes major players such as AbbVie Inc. and Cipla Inc. These companies are investing heavily in research and development to improve treatment options and expand their market share. The market share data is available for different regions, including North America, Europe, Asia-Pacific, and others[1].

Clinical Efficacy and Safety

Lopinavir/ritonavir has been shown to be efficacious and safe in various clinical studies. A meta-analysis highlighted that lopinavir/ritonavir-based regimens demonstrate high virologic suppression rates and low resistance as second-line antiretroviral therapy. However, the drug did not show significant benefits in treating COVID-19 in a large-scale randomized clinical trial[2][5].

COVID-19 Impact

Although lopinavir/ritonavir was initially considered as a potential treatment for COVID-19, a randomized trial conducted as part of the RECOVERY study found no significant difference in outcomes between patients treated with lopinavir/ritonavir and those receiving usual care. This finding has limited the use of lopinavir/ritonavir for COVID-19 treatment[5].

Key Takeaways

• The global lopinavir/ritonavir market is expected to grow at a CAGR of 5% from 2021 to 2028.
• The market is driven by the rising prevalence of HIV/AIDS, government initiatives, and advancements in treatment options.
• High cost of treatment and adverse reactions are significant challenges.
• The India market is expected to grow significantly, driven by infrastructure development and government support.
• Lopinavir/ritonavir has shown efficacy and safety in HIV treatment but not in COVID-19 treatment.

FAQs

Q: What are the primary uses of lopinavir/ritonavir? A: Lopinavir/ritonavir is primarily used in the treatment of HIV/AIDS and has also been explored for its potential in treating other conditions like COVID-19.

Q: What is the expected growth rate of the global lopinavir/ritonavir market? A: The global lopinavir/ritonavir market is expected to grow at a CAGR of 5% from 2021 to 2028.

Q: Which regions dominate the lopinavir/ritonavir market? A: North America currently dominates the market, but the Asia-Pacific and European regions are also expected to show significant growth.

Q: What are the major challenges facing the lopinavir/ritonavir market? A: High cost of treatment, adverse reactions, and lack of awareness are significant challenges.

Q: Did lopinavir/ritonavir show any benefits in treating COVID-19? A: No, a large-scale randomized clinical trial found no significant benefits of lopinavir/ritonavir in treating COVID-19.

Sources:

1. Data Bridge Market Research - Global Lopinavir/ritonavir Market – Global Industry Trends and Forecast to 2028.
2. Frontiers in Pharmacology - Assessing the Efficacy of Lopinavir/Ritonavir-Based Preferred and Simplified Second-Line Antiretroviral Therapy in HIV-Infected Patients.
3. PubMed - Cost-effectiveness of lopinavir/ritonavir versus nelfinavir as the first protease inhibitor in an antiretroviral regimen.
4. TechSci Research - India Lopinavir & Ritonavir Market By Size, Share & Forecast 2030F.
5. The Lancet - Lopinavir–ritonavir in patients admitted to hospital with COVID-19: a randomised, controlled, open-label, platform trial.