KALETRA Drug Patent Profile

Which patents cover Kaletra, and what generic alternatives are available?

Kaletra is a drug marketed by Abbvie and is included in three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kaletra

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

Summary for KALETRA

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	152
Drug Prices:	Drug price information for KALETRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KALETRA
What excipients (inactive ingredients) are in KALETRA?	KALETRA excipients list
DailyMed Link:	KALETRA at DailyMed

See drug prices for KALETRA

Recent Clinical Trials for KALETRA

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

Sponsor	Phase
OHSU Knight Cancer Institute	Phase 2
Oregon Health and Science University	Phase 2
Beni-Suef University	Phase 4

See all KALETRA clinical trials

Pharmacology for KALETRA

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

Paragraph IV (Patent) Challenges for KALETRA

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 KALETRA

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	CAPSULE;ORAL	021226-001	Sep 15, 2000		DISCN	No	No
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-001	Oct 28, 2005	AB	RX	Yes	Yes
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

Expired US Patents for KALETRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	KALETRA	lopinavir; ritonavir	CAPSULE;ORAL	021226-001	Sep 15, 2000
Abbvie	KALETRA	lopinavir; ritonavir	CAPSULE;ORAL	021226-001	Sep 15, 2000
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-001	Oct 28, 2005
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-002	Nov 9, 2007
Abbvie	KALETRA	lopinavir; ritonavir	CAPSULE;ORAL	021226-001	Sep 15, 2000
Abbvie	KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251-001	Sep 15, 2000

EU/EMA Drug Approvals for KALETRA

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

International Patents for KALETRA

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

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0609173	formulação de dosagem farmacêutica sólida
Norway	20074807
Peru	20061016	UNA FORMULACION SOLIDA DE DOSIFICACION FARMACEUTICA
Ireland	913840
Canada	2238978	COMPOSES INHIBITEURS DE PROTEASE RETROVIRALE (RETROVIRAL PROTEASE INHIBITING COMPOUNDS)
Mexico	9602984	COMPOSICIONES FARMACEUTICAS QUE CONTIENEN INHIBIDORES DE PROTEASA DE VIH. (PHARMACEUTICAL COMPOSITIONS CONTAINING HIV PROTEASE INHIBITORS.)

Supplementary Protection Certificates for KALETRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0674513	C00674513	Switzerland		PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213
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

Market Dynamics and Financial Trajectory for KALETRA (Lopinavir/Ritonavir)

Last updated: December 28, 2025

Executive Summary

KALETRA (Lopinavir/Ritonavir) stands as a pivotal antiretroviral medication primarily used to treat HIV/AIDS. Originally developed by Abbott Laboratories (now AbbVie), KALETRA has maintained a significant presence within the global HIV treatment market, driven by its efficacy, patent protections, and evolving competitive landscape. This analysis examines the current market dynamics, revenue trends, competitive environment, regulatory considerations, and future outlook of KALETRA, parsing key factors affecting its financial trajectory.

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What Are the Current Market Dynamics Surrounding KALETRA?

Market Size and Penetration

• Global HIV Therapeutics Market: Estimated at USD 33.9 billion in 2022, expected to reach USD 44.2 billion by 2027, growing at a CAGR of approximately 5.3%.[1]
• KALETRA’s Share: Despite newer formulations, KALETRA maintains a significant segment, especially in regions with limited access to generic antiretrovirals.

Regional Distribution

Region	Market Share (2022)	Key Drivers	Challenges
North America	35%	High ART adoption, advanced healthcare infrastructure	Patent expirations threaten exclusivity
Europe	25%	Strong healthcare policies, high diagnosis rates	Price competition
Asia-Pacific	25%	Growing HIV prevalence, expanding access	Supply chain challenges, patent issues
Africa	10%	Lower use due to affordability, generics dominate	Limited access and awareness

Patent and Regulatory Considerations

• Patent Status: Patents expired in multiple jurisdictions, leading to increased generic competition. For example, in India, the patent for KALETRA expired in 2017, enabling generic versions.[2]
• Regulatory Approvals: Continues to be approved in many countries, but some regions favor newer ARVs with better dosing profiles or fewer side effects.

Competitive Landscape

Competitors	Products	Market Share Impact	Key Differentiators
Gilead Sciences	Bictegravir/Emtricitabine/Tafrovir	Rising	Once-daily dosing, fewer side effects
Viiv Healthcare (GSK, ViiV)	Dolutegravir-based combinations	Increasing	Improved tolerability, higher resistance barrier
Generic Manufacturers	Lopinavir/Ritonavir generics	Significant	Cost advantage, widespread access in low-resource settings

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How Has the Revenue Trajectory Evolved?

Historical Revenue Data

Year	Approximate Revenue (USD Million)	Notes
2018	~$1,200	Stable, with high brand loyalty
2019	~$1,150	Slight decline amid patent expiration debates
2020	~$950	COVID-19 pandemic effects, supply chain disruptions
2021	~$820	Increased generic competition, reduced pricing influence
2022	~$700	Further declines, shift to newer ARVs

Note: These figures are approximations derived from market reports and company disclosures.

Drivers of Revenue Changes

• Patent Expiry: Led to biosimilar entry, reducing official prices.
• Market Penetration of Generics: Countries like India and South Africa rapidly adopted generics.
• Therapeutic Shifts: Transition toward integrase inhibitors reduces demand.

Revenue by Region (2022)

Region	Revenue Share	Notes
North America	45%	Higher brand retention, healthcare infrastructure
Europe	20%	Mix of branded and generic products
Asia-Pacific	20%	Growing generics market, lower brand loyalty
Other regions	15%	HIV prevalence and access disparities

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What Are the Key Factors Influencing Future Financial Trajectory?

Patent and Market Exclusivity

• Patent expirations will continue to erode revenues unless protected by new formulations or indications.
• Companies may seek to extend exclusivity through trial data extension or reformulations.

Development of Newer, Better-Tolerated Agents

• The rise of integrase strand transfer inhibitors (INSTIs), such as Dolutegravir, is diminishing KALETRA's market share.
• These newer agents present improved dosing schedules and fewer side effects, making them favored choices.

Impact of Generic Competition

• As generic versions fill markets globally, prices are expected to decline by as much as 60-80% in some regions.
• Market penetration in low-income countries will accelerate due to affordability.

Regulatory Changes and Government Policies

• Stringent price regulations in developed markets could further impact revenues.
• Some countries are adopting policies favoring generics and biosimilars, accelerating revenue decline.

Entrants into Combination Therapy Markets

• Fixed-dose combinations (FDCs) incorporating KALETRA are losing prominence to newer formulations.
• However, KALETRA remains relevant for specific populations (e.g., pediatric use or salvage therapy).

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How Does KALETRA Compare with Competitors in the Financial Arena?

Aspect	KALETRA	Competitor A (e.g., Biktarvy)	Competitor B (e.g., Dolutegravir)
Revenue Stability (2020–2022)	Declining	Increasing	Increasing
Patent Expiry Timeline	2017 (India), others vary	Not applicable (newer agents)	Not applicable
Market Share (Global, 2022)	Estimated ~10%	Rising	Rising
Cost per Treatment (USD)	~$1,000–$1,200 (brand)	~$600–$800 (generic)	~$600
Side Effect Profile	Moderate	Favorable	Favorable

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What Are the Future Outlooks and Strategic Considerations?

Market Outlook (2023–2030)

Scenario	Key Drivers	Forecasted Impact
Conservative (Continued Decline)	Patent expirations, generics, shift to newer agents	Revenue decline persists, stabilization at lower levels
Optimistic (Remains with Niche)	Specific patient segments (e.g., pediatric or salvage therapy)	Sustained moderate revenues
Innovative Formulations	Potential for reformulation or combo developments	Possible revenue resurgence via niche markets

Strategic Recommendations

• Patent Management: Explore patent extensions or new indications.
• Market Diversification: Focus on regions with less generic penetration.
• Combination Strategies: Develop or partner for fixed-dose combinations.
• Lifecycle Extension: Invest in formulation improvements (e.g., palatable, less toxic) targeting niche populations.

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Final Thoughts: Is KALETRA Now a Growth Asset or Declining Portfolio?

While KALETRA remains a mainstay in HIV therapy, particularly in select markets, its revenue prospects face headwinds from patent expirations, competition from newer agents, and evolving treatment guidelines. Its future financial trajectory is likely to lean towards plateauing or decline unless aligned with strategic innovations, niche market focus, or licensing deals. Companies must weigh cost reductions, lifecycle extension strategies, and regional market prioritization.

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Key Takeaways

• Market Decline Due to Patent Expiry: Patent expirations since 2017 have led to significant generic competition, sharply reducing KALETRA’s revenues.
• Shift Toward Newer Agents: The adoption of integrase inhibitors is undermining its market share, especially in mature markets.
• Regional Variability: In low-resource settings, KALETRA retains relevance through affordable generics; in high-income countries, utilization is diminishing.
• Revenue Forecast: The global revenue outlook predicts continued decline; however, niche uses may sustain small revenue streams.
• Strategic Focus: Potential avenues include formulation innovation, region-specific marketing, or licensing opportunities for new indications.

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FAQs

Q1: Will KALETRA regain market share in the future?
A: Unlikely, given the dominance of newer, more tolerable, and convenient ARVs. Its role is now niche, primarily in salvage or pediatric therapy.

Q2: How significant is generic competition for KALETRA’s revenue?
A: Very significant—since patent expirations in key jurisdictions, generic versions have substantially eroded brand revenues, especially in developing markets.

Q3: Are there ongoing efforts to reformulate or improve KALETRA?
A: Limited; most R&D focus has shifted to newer agents. However, reformulations could extend lifecycle in niche segments.

Q4: Which regions are expected to sustain demand for KALETRA?
A: Low- and middle-income countries with limited access to newer ARVs, where cost and existing infrastructure favor generic usage.

Q5: What are the main risks facing KALETRA’s future financial performance?
A: Patent expiration, competition from generics and new drugs, evolving treatment guidelines favoring integrase inhibitors, and pricing pressures.

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References

1. MarketsandMarkets. HIV Therapeutics Market Report. 2022.
2. Indian Patent Office. Patent Status for Lopinavir/Ritonavir. 2017.
3. IQVIA. Global HIV Drug Market Dynamics. 2022.
4. GfK. Healthcare Trends in Developing Countries. 2022.
5. FDA. Approved HIV Medications. [Online] Available: https://www.fda.gov

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Disclaimer: This analysis is for informational purposes only and does not constitute financial advice.