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Last Updated: April 5, 2025

LOPINAVIR AND RITONAVIR Drug Patent Profile


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Which patents cover Lopinavir And Ritonavir, and when can generic versions of Lopinavir And Ritonavir launch?

Lopinavir And Ritonavir is a drug marketed by Lannett Co Inc, Hetero Labs Ltd Iii, Laurus, Macleods Pharms Ltd, and Mylan Labs Ltd. and is included in five NDAs.

The generic ingredient in LOPINAVIR AND RITONAVIR is lopinavir; ritonavir. There are thirteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the lopinavir; ritonavir profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Lopinavir And Ritonavir

A generic version of LOPINAVIR AND RITONAVIR was approved as lopinavir; ritonavir by LANNETT CO INC on December 27th, 2016.

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Drug patent expirations by year for LOPINAVIR AND RITONAVIR

US Patents and Regulatory Information for LOPINAVIR AND RITONAVIR

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Mylan Labs Ltd LOPINAVIR AND RITONAVIR lopinavir; ritonavir TABLET;ORAL 079074-001 Feb 7, 2024 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hetero Labs Ltd Iii LOPINAVIR AND RITONAVIR lopinavir; ritonavir TABLET;ORAL 091677-001 Jun 4, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hetero Labs Ltd Iii LOPINAVIR AND RITONAVIR lopinavir; ritonavir TABLET;ORAL 091677-002 Jun 4, 2021 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Macleods Pharms Ltd LOPINAVIR AND RITONAVIR lopinavir; ritonavir TABLET;ORAL 204739-002 Jul 25, 2024 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Lannett Co Inc LOPINAVIR AND RITONAVIR lopinavir; ritonavir SOLUTION;ORAL 207407-001 Dec 27, 2016 AA RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Laurus LOPINAVIR AND RITONAVIR lopinavir; ritonavir TABLET;ORAL 213857-001 Mar 21, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 6 of 6 entries

EU/EMA Drug Approvals for LOPINAVIR AND RITONAVIR

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing 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
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 2 of 2 entries

Market Dynamics and Financial Trajectory for Lopinavir and Ritonavir

Introduction to Lopinavir and Ritonavir

Lopinavir and ritonavir, commonly known by the brand name Kaletra, are a combination of antiretroviral medications used primarily to treat HIV-1 infection. This combination is a protease inhibitor, which works by blocking the HIV virus's ability to replicate and spread within the body.

Market Size and Growth

The global lopinavir/ritonavir market is anticipated to experience significant growth over the forecast period of 2021 to 2028. According to market analyses, the market is expected to grow at a Compound Annual Growth Rate (CAGR) of 5% during this period[1].

Key Drivers of Market Growth

Several factors are driving the growth of the lopinavir/ritonavir market:

  • Rising Prevalence of HIV: The increasing number of HIV cases globally is a major driver, as more patients require effective antiretroviral therapies[1].
  • Government Initiatives: Growing government support and initiatives aimed at improving healthcare access and reducing the burden of HIV/AIDS contribute to market expansion[1].
  • Advancements in Treatment Options: Continuous research and development in antiretroviral therapies, including the improvement of existing treatments like lopinavir/ritonavir, are crucial drivers[1].
  • Increasing Awareness: Rising awareness about HIV/AIDS and the importance of antiretroviral treatment among the general public and healthcare providers also boosts market growth[1].

Market Segmentation

The lopinavir/ritonavir market is segmented based on several criteria:

  • Type: Antiretroviral and protease inhibitor (anti-HIV)[1].
  • Dosage: Tablet, capsule, and oral solution[1].
  • Route of Administration: Oral and other routes[1].
  • Application: Primarily for Human Immunodeficiency Virus-1 (HIV-1) and other applications[1].
  • Demographic: Adult and pediatric[1].
  • End-Users: Clinics, hospitals, and others[1].
  • Distribution Channel: Hospital pharmacy, retail pharmacy, and online pharmacy[1].

Regional Analysis

The market is analyzed across various regions, with North America currently dominating due to the presence of major key players, a well-developed healthcare sector, and increasing awareness. The Asia-Pacific and European regions are also expected to grow significantly due to increasing research and development activities, growing awareness, and rising investment in the healthcare sector[1].

Competitive Landscape

The competitive landscape of the lopinavir/ritonavir market includes major players such as AbbVie Inc. and Cipla Inc., among other domestic and global players. Market share data is available for different regions, and competitive analysis highlights the strengths, weaknesses, and market strategies of each competitor[1].

Financial Impact and Cost-Effectiveness

Studies have shown that lopinavir/ritonavir is cost-effective compared to other antiretroviral regimens. For instance, a study comparing lopinavir/ritonavir with nelfinavir estimated that lopinavir/ritonavir could save $3,461 USD per patient in total HIV care costs over the first five years, and up to $5,546 USD when considering the resistance advantage of lopinavir/ritonavir[2].

Challenges and Restraints

Despite the positive market outlook, several challenges and restraints affect the growth of the lopinavir/ritonavir market:

  • High Cost of Treatment: The high cost of antiretroviral therapy, including lopinavir/ritonavir, is a significant barrier, especially in low-income countries[1].
  • Adverse Reactions: Common side effects such as diarrhea, nausea, vomiting, hypertriglyceridemia, and hypercholesterolemia can deter patients from adhering to the treatment regimen[3].
  • Lack of Awareness: Limited awareness about HIV/AIDS and the availability of effective treatments in some regions hampers market growth[1].

COVID-19 Impact

During the COVID-19 pandemic, lopinavir/ritonavir was investigated as a potential treatment for COVID-19, although it was not licensed for this use. The drug was included in several clinical trials, such as the RECOVERY trial, to evaluate its efficacy against COVID-19. However, these trials did not yield conclusive results that would support its widespread use for COVID-19 treatment[5].

Future Outlook and Opportunities

The future of the lopinavir/ritonavir market looks promising due to ongoing research and development activities, including clinical trials and the advancement of treatment options. Rising R&D activities and the focus of pharmaceutical companies on developing more effective and safer treatments will provide beneficial opportunities for market growth[1].

Technological Innovations and Market Trends

Technological advancements in drug formulation, such as the development of more convenient dosing forms (e.g., tablets vs. capsules), and improvements in manufacturing processes are expected to influence the market positively. Additionally, the integration of digital health technologies to enhance patient adherence and monitoring will be a key trend[4].

Regional Expansion and Market Attractiveness

Regions with growing healthcare investments and increasing awareness about HIV/AIDS, such as Asia-Pacific and Latin America, are expected to be highly attractive for market expansion. The market attractiveness in these regions is driven by government initiatives, rising disposable incomes, and a growing demand for quality healthcare services[1].

Key Takeaways

  • The global lopinavir/ritonavir market is expected to grow at a CAGR of 5% from 2021 to 2028.
  • Key drivers include the rising prevalence of HIV, government initiatives, advancements in treatment options, and increasing awareness.
  • The market is segmented based on type, dosage, route of administration, application, demographic, end-users, and distribution channel.
  • North America dominates the market, but Asia-Pacific and Europe are expected to grow significantly.
  • High cost of treatment and adverse reactions are significant challenges.
  • Ongoing R&D activities and technological innovations are expected to drive future growth.

FAQs

What is the primary use of lopinavir and ritonavir?

Lopinavir and ritonavir are primarily used to treat Human Immunodeficiency Virus-1 (HIV-1) infection in combination with other antiretroviral medications.

Which regions are expected to dominate the lopinavir/ritonavir market?

North America currently dominates the market, but the Asia-Pacific and European regions are expected to grow significantly during the forecast period.

What are the common side effects of lopinavir/ritonavir?

Common side effects include diarrhea, nausea, vomiting, hypertriglyceridemia, and hypercholesterolemia. Serious side effects can include diabetes, immune reconstitution syndrome, and increased fat levels in the blood[3].

Is lopinavir/ritonavir cost-effective compared to other antiretroviral regimens?

Yes, studies have shown that lopinavir/ritonavir can be cost-effective, saving up to $5,546 USD per patient over five years compared to nelfinavir[2].

Were lopinavir and ritonavir used as treatments for COVID-19?

Lopinavir/ritonavir were investigated as potential treatments for COVID-19 in several clinical trials, but they were not licensed for this use and did not yield conclusive results supporting widespread use for COVID-19 treatment[5].

Cited Sources:

  1. Data Bridge Market Research, "Global Lopinavir/ritonavir Market – Global Industry Trends and Forecast to 2028".
  2. PubMed, "Cost-effectiveness of lopinavir/ritonavir versus nelfinavir as the first HAART regimen in treating HIV patients".
  3. AbbVie, "KALETRA® (lopinavir/ritonavir) - Antiretroviral Medication".
  4. Cognitive Market Research, "Lopinavir and Ritonavir Market Report 2024 (Global Edition)".
  5. The Pharmaceutical Journal, "Investigational treatments for COVID-19".

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