RITONAVIR - Generic Drug Details

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

Ritonavir is the generic ingredient in two branded drugs marketed by Abbott, Abbvie, Hikma, Norvium Bioscience, Amneal, Aurobindo Pharma Ltd, Cipla, and Hetero Labs Ltd Iii, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for ritonavir. Seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for RITONAVIR

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	12
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	1,019
Drug Prices:	Drug price trends for RITONAVIR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RITONAVIR
What excipients (inactive ingredients) are in RITONAVIR?	RITONAVIR excipients list
DailyMed Link:	RITONAVIR at DailyMed

See drug prices for RITONAVIR

Recent Clinical Trials for RITONAVIR

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

Sponsor	Phase
AMS-PHPT Research Collaboration	Phase 1/Phase 2
University of Zimbabwe Clinical Research Centre (UZCRC)	Phase 1/Phase 2
Centre Hospitalier National d'Enfants Albert Royer	Phase 1/Phase 2

See all RITONAVIR clinical trials

Generic filers with tentative approvals for RITONAVIR

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET;ORAL
		50MG	TABLET; ORAL
		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 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 P-Glycoprotein Inhibitors UDP Glucuronosyltransferases Inducers

Medical Subject Heading (MeSH) Categories for RITONAVIR

Cytochrome P-450 CYP3A Inhibitors

HIV Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RITONAVIR

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

Paragraph IV (Patent) Challenges for RITONAVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NORVIR	Tablets	ritonavir	100 mg	022417	1	2010-12-21

US Patents and Regulatory Information for RITONAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	RITONAVIR	ritonavir	CAPSULE;ORAL	205024-001	Feb 16, 2024		RX	No	No
Abbvie	NORVIR	ritonavir	POWDER;ORAL	209512-001	Jun 7, 2017		RX	Yes	Yes
Abbott	NORVIR	ritonavir	CAPSULE;ORAL	020680-001	Mar 1, 1996		DISCN	No	No
Abbvie	NORVIR	ritonavir	TABLET;ORAL	022417-001	Feb 10, 2010	AB	RX	Yes	Yes
Aurobindo Pharma Ltd	RITONAVIR	ritonavir	TABLET;ORAL	206614-001	Sep 17, 2018	AB	RX	No	No
Hetero Labs Ltd Iii	RITONAVIR	ritonavir	TABLET;ORAL	204587-001	Sep 17, 2018	AB	RX	No	No
Hikma	RITONAVIR	ritonavir	CAPSULE;ORAL	205801-001	Dec 3, 2020		DISCN	No	No

Expired US Patents for RITONAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996
Abbvie	NORVIR	ritonavir	CAPSULE;ORAL	020945-001	Jun 29, 1999
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996
Abbvie	NORVIR	ritonavir	TABLET;ORAL	022417-001	Feb 10, 2010
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996
Abbvie	NORVIR	ritonavir	CAPSULE;ORAL	020945-001	Jun 29, 1999

EU/EMA Drug Approvals for RITONAVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan S.A.S	Ritonavir Mylan	ritonavir	EMEA/H/C/004549 Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV 1 infected patients (adults and children of 2 years of age and older).	Authorised	yes	no	no	2017-11-09
AbbVie Deutschland GmbH Co. KG	Norvir	ritonavir	EMEA/H/C/000127 Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1-infected patients (adults and children of two years of age and older).	Authorised	no	no	no	1996-08-25

RITONAVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ritonavir

Introduction to Ritonavir

Ritonavir, a protease inhibitor, is a crucial component in the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) and has also been approved for the treatment of COVID-19. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth Projections

The global ritonavir market is anticipated to experience significant growth over the forecast period. According to market research, the ritonavir market is expected to increase at a Compound Annual Growth Rate (CAGR) of 3 to 5% from 2021 to 2031, reaching a substantial valuation by the end of this period[4].

Segmentation of the Ritonavir Market

The ritonavir market is segmented based on several key factors:

• Application: The market is categorized into adult and pediatric use. Ritonavir is used in combination with other antiretroviral agents for the treatment of HIV-1 infection and, more recently, for COVID-19 in adults at high risk of severe illness[5].
• Product Form: Ritonavir is available in various forms, including tablets, oral solutions, and oral powders. This diversity in product forms caters to different patient needs and preferences[4].
• Geographical Regions: The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America, particularly the U.S., dominates the market due to the presence of major pharmaceutical companies and a well-developed healthcare sector[1][3].

Drivers of Market Growth

Several factors are driving the growth of the ritonavir market:

• Increasing Prevalence of Diseases: The rising prevalence of HIV and COVID-19 has increased the demand for effective treatments, contributing to the market growth of ritonavir[1].
• Government Initiatives and Awareness: Growing government initiatives and increasing awareness about the importance of antiretroviral therapy and COVID-19 treatments are boosting the market[1].
• Advancements in Treatment Options: Continuous research and development activities, including ongoing clinical trials, are expanding the therapeutic applications of ritonavir and improving treatment outcomes[1].
• Pharmaceutical Company Focus: Major pharmaceutical companies are focusing on developing more treatment options, which includes ritonavir, further driving market growth[1].

Challenges and Restraints

Despite the positive outlook, there are several challenges that could impact the market:

• High Cost of Treatment: The high cost of ritonavir and associated treatments can be a significant barrier, especially in regions with limited healthcare resources[1].
• Adverse Reactions: Ritonavir is associated with adverse reactions such as diarrhea, nausea, vomiting, hypertriglyceridemia, and hypercholesterolemia, which can deter some patients[1][5].
• Lack of Awareness: In some regions, there is a lack of awareness about the benefits and availability of ritonavir, which can hinder market growth[1].

Financial Impact and Budget Considerations

The financial impact of ritonavir, particularly in the context of COVID-19 treatment, is noteworthy. A study on the budget impact of nirmatrelvir/ritonavir (NMV/r) in adults at high risk for severe COVID-19 estimated that the treatment could result in substantial cost offsets due to reductions in hospitalizations. The analysis suggested a total budget impact of $2,733,745, with a per patient per year (PPPY) cost of $91 and a per member per month (PMPM) cost of $0.23. When including post-COVID conditions, the treatment was found to be cost-saving[2].

Competitive Landscape

The global ritonavir market is competitive, with several key players involved:

• AbbVie Inc.: Known for its brand Kaletra, which is a fixed-dose combination of lopinavir and ritonavir[1].
• Cipla Inc.: Another major player that offers ritonavir in various formulations[1].
• Other Players: The market also includes other domestic and global players, each with their own market share and competitive strategies[1].

Regional Market Dynamics

• North America: Dominates the market due to the presence of major pharmaceutical companies and a well-developed healthcare sector[1].
• Asia-Pacific and Europe: Expected to grow significantly due to increasing research and development activities, growing awareness, and rising investment in the healthcare sector[1].
• Other Regions: The market in South America, the Middle East, and Africa is also expected to grow, though at a slower pace compared to the more developed regions[1].

Key Takeaways

• The ritonavir market is projected to grow at a CAGR of 3 to 5% from 2021 to 2031.
• The market is driven by increasing disease prevalence, government initiatives, and advancements in treatment options.
• High treatment costs and adverse reactions are significant challenges.
• The financial impact of ritonavir, especially in COVID-19 treatment, shows potential for cost savings through reduced hospitalizations.
• The competitive landscape includes major players like AbbVie Inc. and Cipla Inc.

FAQs

What is ritonavir used for?

Ritonavir is used in combination with other antiretroviral agents for the treatment of HIV-1 infection and, more recently, for the treatment of mild-to-moderate COVID-19 in adults at high risk of severe illness[5].

What are the common adverse reactions associated with ritonavir?

Common adverse reactions include diarrhea, nausea, vomiting, hypertriglyceridemia, and hypercholesterolemia. Other effects can include hepatotoxicity, pancreatitis, and allergic reactions/hypersensitivity[1][5].

How does ritonavir impact healthcare costs?

Ritonavir, particularly when used in combination with nirmatrelvir for COVID-19, can result in substantial cost offsets due to reductions in hospitalizations, potentially leading to overall cost savings[2].

Which regions dominate the ritonavir market?

North America, particularly the U.S., dominates the market due to the presence of major pharmaceutical companies and a well-developed healthcare sector. Asia-Pacific and Europe are also significant regions with growing market potential[1].

What are the key drivers of the ritonavir market growth?

Key drivers include the increasing prevalence of diseases, government initiatives, advancements in treatment options, and the growing focus of pharmaceutical companies on developing more treatment options[1].

Sources

1. Data Bridge Market Research: Global Lopinavir/Ritonavir Market – Global Industry Trends and Forecast to 2028.
2. PubMed: Budget impact of oral nirmatrelvir/ritonavir in adults at high risk for progression to severe COVID-19.
3. Market Research Intellect: Informe de pronóstico, alcance y tamaño del mercado de ventas de ritonavir.
4. Market Research Intellect: Global Ritonavir Market Size And Forecast.
5. DrugBank Online: Ritonavir: Uses, Interactions, Mechanism of Action.