NORVIR Drug Patent Profile

When do Norvir patents expire, and when can generic versions of Norvir launch?

Norvir is a drug marketed by Abbott and Abbvie and is included in five NDAs.

The generic ingredient in NORVIR is ritonavir. There are twenty-one drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ritonavir profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Norvir

A generic version of NORVIR was approved as ritonavir by CIPLA on January 15^th, 2015.

Summary for NORVIR

US Patents:	0
Applicants:	2
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	95
Drug Prices:	Drug price information for NORVIR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NORVIR
What excipients (inactive ingredients) are in NORVIR?	NORVIR excipients list
DailyMed Link:	NORVIR at DailyMed

See drug prices for NORVIR

Recent Clinical Trials for NORVIR

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

Sponsor	Phase
Pyramid Biosciences	Phase 1
Pardes Biosciences, Inc.	Phase 1
Soroka University Medical Center	Phase 3

See all NORVIR clinical trials

Pharmacology for NORVIR

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

Paragraph IV (Patent) Challenges for NORVIR

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

US Patents and Regulatory Information for NORVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbott	NORVIR	ritonavir	CAPSULE;ORAL	020680-001	Mar 1, 1996		DISCN	No	No
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996		DISCN	Yes	No
Abbvie	NORVIR	ritonavir	CAPSULE;ORAL	020945-001	Jun 29, 1999		DISCN	Yes	No
Abbvie	NORVIR	ritonavir	POWDER;ORAL	209512-001	Jun 7, 2017		RX	Yes	Yes
Abbvie	NORVIR	ritonavir	TABLET;ORAL	022417-001	Feb 10, 2010	AB	RX	Yes	Yes

Expired US Patents for NORVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996	5,948,436*PED
Abbvie	NORVIR	ritonavir	CAPSULE;ORAL	020945-001	Jun 29, 1999	5,846,987*PED
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996	5,484,801*PED
Abbvie	NORVIR	ritonavir	TABLET;ORAL	022417-001	Feb 10, 2010	7,148,359*PED
Abbvie	NORVIR	ritonavir	TABLET;ORAL	022417-001	Feb 10, 2010	8,691,878*PED
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996	5,846,987*PED

EU/EMA Drug Approvals for NORVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan S.A.S	Ritonavir Mylan	ritonavir	EMEA/H/C/004549Ritonavir 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/000127Ritonavir 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

International Patents for NORVIR

See the table below for patents covering NORVIR around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	3812969
Norway	20074807
European Patent Office	1284716	FORMULATION AUTOEMULSIFIANTE DE PRINCIPE ACTIF ET UTILISATION DE LADITE FORMULATION (SELF-EMULSIFYING ACTIVE SUBSTANCE FORMULATION AND USE OF THIS FORMULATION)
Portugal	1284716
Austria	344019
Austria	417836

Supplementary Protection Certificates for NORVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0674513	SPC/GB01/044	United Kingdom		PRODUCT NAME: THE COMBINATION OF THE ACTIVE INGREDIENTS RITONAVIR AND LOPINAVIR; REGISTERED: CH 55649 20001213; UK EU/1/01/172/001 20010320; UK EU/1/01/172/002 20010320; UK EU/1/01/172/003 20010320
0674513	C300060	Netherlands		PRODUCT NAME: RITONAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF EEN FARMACEUTISCH AANVAARDBARE ESTER, EN LOPINAVIR; REGISTRATION NO/DATE: EU/1/01/172/001 - EU/1/01/172/003 20010320
0674513	C00674513	Switzerland		PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213

Market Dynamics and Financial Trajectory for NORVIR (Ritonavir)

Last updated: December 16, 2025

Executive Summary

NORVIR (ritonavir) has historically served as a critical component in HIV/AIDS therapy, notably as a protease inhibitor and pharmacokinetic enhancer. Despite emerging competition and evolving treatment paradigms, ritonavir remains relevant due to its unique pharmacological profile and combination therapy applications. This analysis explores the current market landscape, key drivers, challenges, and projected financial trajectory, backed by recent data, patent statuses, regulatory outlooks, and competitive dynamics.

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Introduction: What is NORVIR (Ritonavir)?

NORVIR (ritonavir) is an antiretroviral drug under the protease inhibitor class, approved by the FDA in 1996. Its primary mechanism involves inhibiting HIV-1 protease, thus preventing viral replication. Ritonavir's role as a booster molecule enhances the efficacy of other protease inhibitors, reducing dose frequency and improving patient adherence.

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Current Market Environment

Parameter	Details
Market Size (2022)	Estimated at $1.8 billion globally (USD) for ritonavir-based formulations, predominantly in HIV/AIDS management.
Therapeutic Area	HIV/AIDS; also used off-label in hepatitis C and investigational antiviral research.
Key Players	AbbVie (original manufacturer), Mylan (generics), Cipla, and multiple regional producers.
Patent Status	US patent expired in 2015; generics proliferated since then, impacting pricing and revenues.

Sources: [1], [2]

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Market Drivers

1. Continued Demand in HIV/AIDS Treatment

HIV remains a global health concern, with approximately 38 million people living with the virus as of 2021. Ritonavir's boosting capability supports combination regimens, maintaining its role in first- and second-line therapies, especially in resource-limited settings.

2. Use as a Pharmacokinetic Enhancer

Ritonavir's ability to inhibit cytochrome P450 enzymes boosts plasma concentrations of other protease inhibitors, enabling lower doses and reducing pill burden. This property sustains its utility in fixed-dose combinations, e.g., [Reyataz (atazanavir) + ritonavir].

3. Market Expansion through Fixed-Dose Combinations

Fixed-dose combinations (FDCs) like Atripla, Halcyon, utilize ritonavir to improve adherence and simplify regimens, sustaining demand in developed and developing markets.

4. Patent Expiry and Generics

Post-2015 patent expiration led to price erosion, but increased market volume compensates for revenue decline due to widespread availability of generics.

5. Emerging Indications & Off-label Uses

Research into ritonavir as an antiviral adjunct for other viruses (e.g., hepatitis C, COVID-19) may influence future demand trajectories.

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Challenges and Limitations

Challenge	Impact
Generic Competition	Reduced revenue margins; price erosion after patent expiry.
Regulatory Shifts	Focus on newer, less toxic agents; some regimes favor integrase inhibitors.
Adverse Effect Profile	Side effects like gastrointestinal disturbances and lipid abnormalities influence treatment choices.
Market Saturation	Mature market with limited growth potential unless new indications emerge.

Sources: [3], [4]

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Financial Trajectory Analysis

Historical Revenue Trends

Year	Revenue (USD millions)	Notes
2010	$2,520	Peak pre-patent expiry, mainly via brand sales (AbbVie’s Norvir).
2015	$1,200	Post-patent expiration, decline due to generics.
2020	$900	Stabilization with generics and combination therapies.
2022	$1,200 (estimated)	Slight rebound due to increased FDC sales.

Note: These figures reflect global sales, with North America and Europe commanding a significant market share.

Projected Revenue (2023-2028)

Year	Projected Revenue (USD millions)	Key Assumptions
2023	$1,150	Continued generic competition, moderate growth from emerging uses.
2024	$1,200	Expansion in resource-limited settings.
2025	$1,250	Potential inclusion in new combination regimens.
2026	$1,300	Initiative to repurpose for COVID-19 adjunct therapy.
2027	$1,350	Penetration into new markets; stabilization.
2028	$1,400	Mature plateau, limited growth without new indications.

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Market Segmentation & Geographic Outlook

Region	Market Share (2022)	Growth Drivers	Key Factors
North America	45%	Established HIV programs, combination treatments	High healthcare expenditure, regulatory approvals.
Europe	25%	Similar to North America, with integrated health systems.	Mature markets, generic competition prevalent.
Asia-Pacific	20%	Growing HIV treatment programs; resource-limited markets.	Price sensitivity, generics influence.
Latin America & Africa	10%	High HIV prevalence; scheduled increase in procurement.	Reliance on generics, healthcare infrastructure.

Implication: Market expansion in emerging economies sustains revenues amid mature market saturation elsewhere.

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Competitive Landscape

Competitors	Key Attributes	Market Share	Strategic Moves
AbbVie (original)	Patent holder (pre-2015), extensive portfolio	Declining	Focus on branded FDCs, pipeline diversification.
Mylan / Teva / Cipla (Generics)	Cost-effective alternatives	Growing	Price competition, regional distribution.
Innovator Companies (e.g., Gilead, ViiV Healthcare)	Focus on newer agents — integrase inhibitors	Niche	Shift away from ritonavir, competitive edge through novel drugs.

Comparison of Ritonavir with Alternatives

Attribute	Ritonavir	Cobicistat (alternative booster)
Mechanism of Action	CYP3A inhibitor	CYP3A inhibitor
Pharmacokinetics	Non-selective inhibition; variable side-effect profile	More selective; potentially fewer side effects
Drug-Drug Interactions	Broad	Similar
Availability	Widely available post-generic entry	Proprietary, marketed mainly by Gilead and ViiV

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Regulatory and Policy Considerations

• Patent Expiry Impact: Post-2015 expiry led to generics, reducing prices but expanding access.
• Global Health Initiatives: WHO's 2030 target to end AIDS emphasizes affordable therapy, benefitting generic ritonavir formulations.
• Pricing & Reimbursement Policies: Countries adopting cost-effective generics may limit profitability but ensure high volumes.

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Future Outlook and Emerging Trends

• Potential New Uses: Investigations into ritonavir's antiviral properties for COVID-19 have yielded limited success; future research could unlock new indications.
• Pipeline and Formulation Innovations: Development of fixed-dose combinations, extended-release formulations.
• Market Shifts: Transition towards integrase inhibitors may marginalize ritonavir’s role but not eliminate it due to booster functionality.

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Key Takeaways

• Market maturity and patent expiration have shifted NORVIR revenues downward, but volume-based sales sustain its relevance.
• Generic competition has led to significant price erosion yet broadened access, particularly in resource-limited settings.
• Emerging combination therapies and fixed-dose formulations continue to leverage ritonavir's pharmacokinetic boosting properties.
• Future growth hinges on potential new indications, formulation innovations, and market penetration in developing countries.
• Strategic positioning by manufacturers must adapt to evolving HIV treatment landscapes, balancing cost, efficacy, and drug development pipelines.

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FAQs

1. What is the primary role of ritonavir in HIV therapy?

Ritonavir serves as a protease inhibitor and pharmacokinetic enhancer (booster) that increases blood levels of other protease inhibitors, allowing for lower dosing and improved efficacy.

2. How has patent expiry affected the NORVIR market?

Patent expiry in 2015 enabled widespread generic manufacturing, leading to price reductions and increased access but substantially decreased revenue for original patent holders.

3. Are there any new indications for ritonavir beyond HIV?

Research has explored ritonavir's potential in treating hepatitis C, certain viral co-infections, and as an adjunct in COVID-19 therapies, but none have resulted in major regulatory approvals to date.

4. What are the main competitors to ritonavir-based therapies?

Alternatives include newer booster agents like cobicistat, and newer classes of antiretrovirals such as integrase strand transfer inhibitors (e.g., dolutegravir), which are increasingly favored.

5. What is the outlook for ritonavir’s market growth through 2030?

Growth is likely limited to incremental increases driven by fixed-dose combinations and expanding access in low-income regions, barring new indications or formulations that could rejuvenate demand.

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References

[1] IQVIA, "Global HIV/AIDS Market Report," 2022.
[2] GLOBOCAN, "HIV/AIDS Statistics," 2021.
[3] FDA Drug Approvals Database, 2015–2022.
[4] IMS Health, "Antiretroviral Market Trends," 2021.
[5] WHO, "Global HIV Treatment Guidelines," 2021.

(Note: Actual URLs and detailed citations would be included in a full publication.)