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	TABLET;ORAL	021906-002	Nov 9, 2007
Abbvie	KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251-001	Sep 15, 2000
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-002	Nov 9, 2007
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-002	Nov 9, 2007
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-001	Oct 28, 2005
Abbvie	KALETRA	lopinavir; ritonavir	CAPSULE;ORAL	021226-001	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
Chile	2013003554	Forma de dosificación farmacéutica sólida en forma de dispersión o solución sólida que comprende ritonavir, entre 50-80% en peso de al menos un polímero soluble en agua con una tg de al menos 50 °c, respecto del peso total de la forma de dosificación, y un tensoactivo (divisional de la sol.1844-2009 y esta divisional de la sol. 393-2006).
Lithuania	2283844
Australia	722812
Switzerland	688551	1,4-Diammino-2-idrossibutani sostituiti
Japan	2761374
Serbia	57938	FORMULACIJA ČVRSTOG OBLIKA DOZIRANJA KOJA SADRŽI LOPINAVIR (A SOLID PHARMACEUTICAL DOSAGE FORMULATION COMPRISING LOPINAVIR)

Supplementary Protection Certificates for KALETRA

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: KALETRA

Last updated: July 29, 2025

---

Introduction

KALETRA, a combination drug comprising lopinavir and ritonavir, is predominantly used as an antiretroviral therapy in the treatment of HIV/AIDS. Initially developed by Abbott Laboratories and later acquired by AbbVie, KALETRA has maintained a prominent position within the antiretroviral market despite evolving treatment paradigms and competitive pressures. This analysis explores the current market dynamics influencing KALETRA and projects its financial trajectory based on the latest industry data, patent landscape, regulatory environment, and healthcare trends.

---

Market Overview and Therapeutic Positioning

KALETRA serves as a protease inhibitor-based therapy designed to inhibit viral replication in HIV-positive patients, often prescribed as part of combination antiretroviral therapy (cART). Its efficacy in reducing viral load and improving immune function established it as a mainstay in HIV management during the early 2000s. However, advancements in antiretroviral agents featuring fewer side effects, simpler dosing regimens, and improved resistance profiles have seen KALETRA’s market share decline over recent years.

As per IQVIA data, the global HIV antiretroviral drug market was valued at approximately USD 38 billion in 2022, with protease inhibitors comprising roughly 45% of the segment. Despite the diminished dominance of traditional protease inhibitors like KALETRA, it remains relevant in specific patient populations, such as those with drug resistance issues or in regions with limited access to newer agents.

---

Market Dynamics Influencing KALETRA

1. Competitive Market Landscape

The evolving antiretroviral landscape is characterized by the introduction of fixed-dose combinations (FDCs) and single-tablet regimens (STRs), which enhance patient adherence and simplify treatment protocols. Drugs such as Gilead’s Biktarvy and ViiV’s Triumeq have garnered substantial market share by offering potent, convenient options. These innovations have marginally displaced older regimens like KALETRA, especially in high-income markets.

Furthermore, the emergence of integrase strand transfer inhibitors (INSTIs) has shifted treatment preferences toward newer agents that demonstrate superior tolerability and resistance profiles. Consequently, KALETRA’s role has become more niche, confined largely to salvage therapy or specific clinical scenarios.

2. Patent and Regulatory Landscape

KALETRA’s original patent life was pivotal in establishing its commercial dominance. However, patent expirations and the subsequent entry of generic lopinavir/ritonavir formulations around 2017 significantly eroded its pricing power, especially in North America and Europe.

In jurisdictions with limited patent enforcement, off-patent versions have increased accessibility but subdued revenue streams for original manufacturers. Additionally, regulatory agencies like the FDA and EMA periodically review safety data, impacting prescribing patterns. Although KALETRA has maintained regulatory approval, concerns over side effects such as dyslipidemia and gastrointestinal disturbances influence prescriber decisions.

3. Regional Market Variations

KALETRA remains critical in regions with constrained healthcare infrastructure, including parts of Africa and Asia. WHO’s prequalification and generic manufacturing support have kept the drug accessible in low- and middle-income countries (LMICs), ensuring continued demand. While this sustains volume, profit margins are lower due to the prevalence of generic competition.

4. Pricing and Reimbursement

Pricing strategies have drastically changed post-patent expiration. Governments and insurance providers increasingly favor cost-effective generic options, pressuring original drug prices. International funding initiatives, such as the Global Fund, favor generics, leading to a decrease in revenues from branded KALETRA in LMICs.

Financial Trajectory and Future Outlook

1. Revenue Projection and Market Share Trends

Historical revenues for KALETRA peaked at approximately USD 1.5 billion in 2012, driven by high global demand. Post-genericization, revenues declined sharply, with estimates indicating approximately USD 600 million in 2022.

Forecasts suggest a continued downward trajectory, with compound annual decline rates (CARR) estimated at approximately 10-12% over the next five years. This contraction is attributable to increasing competition from newer agents, patent expiration, and shifting treatment guidelines favoring INSTIs over protease inhibitors.

2. Strategic Positioning and Portfolio Integration

Pharmaceutical companies may leverage KALETRA’s existing manufacturing capabilities by focusing on niche markets or formulation innovations. For instance, reformulating KALETRA into lower-dose or pediatric-specific formulations could sustain marginal revenues. Additionally, licensing generic versions in LMICs remains a viable revenue stream.

3. Impact of Innovation and Pipeline Development

Although KALETRA itself faces obsolescence, its legacy informs ongoing research into protease inhibitors. The development pipeline includes next-generation drugs with improved resistance profiles and reduced toxicity. The successful commercialization of these agents could further diminish KALETRA’s market relevance.

Conversely, some industry insiders foresee potential repositioning of KALETRA in combination regimens for multi-drug resistant HIV strains, potentially stabilizing its demand in niche markets.

4. Regional Market Dynamics and Emerging Opportunities

In resource-limited settings, demand persists due to affordability and existing infrastructure. The integration of KALETRA into global health initiatives ensures a baseline revenue stream, albeit with minimal growth prospects.

Moreover, partnerships with government agencies and non-governmental organizations (NGOs) focusing on HIV/AIDS relief may provide incremental stability.

---

Regulatory and Healthcare Trends Impacting Future Revenues

• Shift to Long-Acting Injectables: The advent of long-acting antiretroviral injectables, such as Gilead’s cabotegravir, shifts focus away from oral regimens like KALETRA.
• Guideline Updates: The World Health Organization’s (WHO) 2021 guidelines favor INSTIs as first-line agents, marginalizing protease inhibitor-based therapies.
• Resistance Considerations: Patients with drug-resistant HIV strains necessitate complex regimens, possibly maintaining niche demand for KALETRA in salvage therapy.

---

Conclusion

KALETRA’s market dynamics reveal a steady decline driven by technological evolution, patent expirations, and strategic shifts toward newer treatment modalities. While its global sales have contracted significantly from historic highs, regional demand persists, especially in LMICs. The drug’s financial trajectory appears set on a declining path, with minimal prospects for reversal absent significant innovation or repositioning.

Industry stakeholders should consider these trends to optimize portfolio management, exploring opportunities in generic manufacturing, formulation innovations, or niche indications despite overarching market contraction.

---

Key Takeaways

• Market decline is inevitable: Post-patent generic competition and evolving clinical guidelines threaten KALETRA’s revenue potential.
• Regional importance persists: In LMICs, KALETRA remains essential due to affordability and infrastructure considerations, offering steady but limited revenue streams.
• Innovation and pipeline development are critical: Future growth opportunities hinge on repositioning or integrating new formulations for specific use cases.
• Strategic partnerships and licensing: These offer avenues to sustain demand in underserved markets.
• Monitoring treatment guidelines and resistance patterns is vital, as they profoundly influence demand trajectories.

---

FAQs

1. What factors led to the decline of KALETRA's market share?
Patent expirations, the advent of more tolerable and effective antiretroviral agents, and shifts in treatment guidelines favoring integrase inhibitors have collectively diminished KALETRA’s prominence.

2. Is KALETRA still recommended in current HIV treatment protocols?
It is generally reserved for salvage therapy or specific cases involving drug resistance, with first-line treatments favoring newer agents like INSTIs.

3. How do regional differences impact the financial outlook for KALETRA?
In high-income countries, the drug’s revenues have significantly declined due to generic competition and treatment shifts, whereas in LMICs, demand persists, providing a stable yet modest revenue base.

4. What are the prospects for KALETRA’s future profitability?
Prospects are limited; revenues are expected to decline further unless strategic repositioning or reformulations are introduced.

5. How are generics affecting KALETRA’s market?
Generics have drastically lowered prices and increased accessibility, eroding the revenue share of original branded formulations, especially where patents have expired.

---

References

[1] IQVIA. "Global HIV Market Report," 2022.
[2] WHO. "Guidelines for HIV Treatment," 2021.
[3] Gilead Sciences. "Long-acting injectable Antiretrovirals," 2022.
[4] FDA. "KALETRA (lopinavir/ritonavir) Drug Label," 2022.
[5] MarketWatch. "Antiretroviral Drug Market Trends," 2023.