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 HETERO LABS LTD III on June 4^th, 2021.

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
October 6 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		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	021906-001	Oct 28, 2005
Abbvie	KALETRA	lopinavir; ritonavir	CAPSULE;ORAL	021226-001	Sep 15, 2000
Abbvie	KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251-001	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	TABLET;ORAL	021906-002	Nov 9, 2007
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-001	Oct 28, 2005

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
Taiwan	I259178
New Zealand	510328	Retroviral protease inhibiting compounds
Norway	20074807
New Zealand	560829	A solid pharmaceutical dosage formulation
Argentina	077411	FORMA DE DOSIFICACION FARMACEUTICA SOLIDA, CON LOPINAVIR Y RITONAVIR, Y PROCESO PARA SU PREPARACION.
Czech Republic	300127	Zpusob prípravy meziproduktu inhibujících proteázy retroviru (Process for preparing retroviral protease inhibiting intermediates)
Portugal	100304

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

KALETRA: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is KALETRA and its Therapeutic Applications?

KALETRA is a prescription medication approved for the treatment of HIV-1 infection in adults and children. It is a protease inhibitor combination product, containing lopinavir and ritonavir. The drug functions by preventing the HIV virus from multiplying and spreading within the body. Its primary indication is for use in combination with other antiretroviral agents. As of its peak market presence, KALETRA was a significant component of HIV treatment regimens, particularly for patients with certain resistance profiles or treatment complexities.

What are the Key Patents Protecting KALETRA?

The intellectual property landscape for KALETRA involves several patents, primarily owned by AbbVie Inc. (formerly Abbott Laboratories). These patents cover the composition of matter, methods of use, and specific formulations of lopinavir and ritonavir.

• Composition of Matter Patents: These are foundational patents that protect the chemical structures of lopinavir and ritonavir.
  • US Patent No. 5,919,776, filed on January 24, 1997, and issued on July 6, 1999, claims lopinavir. This patent expired on January 24, 2017.
  • US Patent No. 5,648,361, filed on February 15, 1995, and issued on July 15, 1997, claims ritonavir. This patent expired on February 15, 2015.
• Formulation and Method of Use Patents: Additional patents protected specific formulations, such as the oral solution and the tablet form, as well as methods of using KALETRA in combination therapies. For example, patents related to optimized dosing regimens and specific patient populations were pursued. The expiration dates for these secondary patents extend beyond the primary composition of matter patents, providing extended market exclusivity.

The interplay of these patent expirations dictates the timeline for generic competition.

What is the Market Size and Revenue Performance of KALETRA?

KALETRA, marketed as Kaletra in many regions, achieved substantial revenue during its patent-protected period. Global sales peaked in the mid-2010s.

• Peak Sales: In 2014, Kaletra generated approximately $1.4 billion in revenue globally for AbbVie. This represented a significant portion of the company's antiretroviral portfolio at the time.
• Declining Revenue Post-Generic Entry: Following the expiration of key composition of matter patents and the subsequent introduction of generic versions, KALETRA's sales have experienced a consistent decline.
  • By 2018, global sales had fallen to approximately $570 million.
  • In 2021, Kaletra sales were reported at approximately $213 million.
  • For the fiscal year 2022, AbbVie reported Kaletra sales of $121 million.
  • In the first nine months of 2023, Kaletra sales were $58 million.

This revenue trajectory is characteristic of a drug facing generic competition after patent expiry.

How Has Generic Competition Impacted KALETRA's Market Share and Pricing?

The introduction of generic lopinavir/ritonavir products has fundamentally altered KALETRA's market position. Generic manufacturers can offer their products at significantly lower price points, driven by lower R&D recoupment costs and increased competition.

• Price Erosion: The average selling price of KALETRA has decreased substantially due to the availability of cheaper generic alternatives. This price erosion is a direct consequence of market forces driven by generic entry.
• Market Share Capture by Generics: Generic lopinavir/ritonavir formulations have captured a significant share of the market. Payers and healthcare providers often favor these lower-cost alternatives, especially in resource-limited settings where cost-effectiveness is paramount. This shift directly reduces the demand for the branded KALETRA product.
• Geographic Variations: The impact of generic competition varies geographically. In developed markets with strong patent enforcement and established healthcare systems, branded KALETRA may retain a small market share among specific patient groups who continue to use it for clinical reasons. However, in emerging markets and lower and middle-income countries, generic penetration is often more rapid and complete due to price sensitivity.

What are the Key Regulatory and Clinical Considerations for KALETRA?

KALETRA's regulatory and clinical journey has been shaped by its efficacy, safety profile, and evolving treatment guidelines.

• FDA Approvals: The U.S. Food and Drug Administration (FDA) approved KALETRA in 2000. Subsequent approvals covered pediatric use and different formulations.
• Evolving Treatment Guidelines: Antiretroviral therapy (ART) guidelines have evolved significantly since KALETRA's introduction. Newer drug classes with improved tolerability, efficacy, and single-tablet regimen options have become preferred first-line treatments for many HIV patients. This has led to KALETRA being primarily used in second-line or salvage therapy settings, particularly for patients who have developed resistance to other protease inhibitors or have complex treatment histories.
• Resistance Issues: The development of drug resistance is a critical clinical consideration for protease inhibitors like KALETRA. Patients who are not adherent to their medication regimen are at higher risk of developing resistance, which can render KALETRA and other protease inhibitors ineffective.
• Drug-Drug Interactions: Ritonavir, one of the components of KALETRA, is a potent inhibitor of CYP3A4 enzymes. This leads to a high potential for drug-drug interactions with numerous other medications, requiring careful management by healthcare providers. This complexity can make KALETRA less desirable compared to agents with fewer interactions.
• Adverse Events: Common side effects associated with KALETRA include gastrointestinal disturbances (diarrhea, nausea, vomiting), fatigue, headache, and hypertriglyceridemia. Long-term use can also be associated with dyslipidemia and potential cardiovascular risks.

What is the Future Market Outlook for KALETRA?

The future market outlook for branded KALETRA is characterized by continued decline in sales due to established generic competition and the availability of newer, more convenient HIV treatment options.

• Sustained Generic Dominance: Generic lopinavir/ritonavir will continue to dominate the market for this drug combination due to price advantages.
• Niche Use in Specific Populations: Branded KALETRA may retain a minor role in specific clinical scenarios, such as in situations where specific patient access programs or historical treatment patterns persist. Its use in salvage therapy for multi-drug resistant HIV could continue, though newer agents are also emerging in this space.
• Geographic Market Dynamics: Sales in regions with high generic penetration will remain low. In developed markets, the shift towards single-tablet regimens and integrase inhibitors will further diminish the use of older protease inhibitor-based regimens.
• AbbVie's Portfolio Shift: AbbVie's strategic focus has shifted to newer HIV therapies and other therapeutic areas. Investments in supporting the branded KALETRA product are likely to be minimal, with the company prioritizing its more recent and higher-growth assets.

The overall trend points to a diminishing market presence for branded KALETRA.

Key Takeaways

• KALETRA (lopinavir/ritonavir) has experienced significant revenue decline following patent expirations and the entry of generic competitors.
• Key patents protecting KALETRA, including composition of matter patents for lopinavir and ritonavir, have expired, enabling generic manufacturing.
• Peak annual sales for KALETRA reached approximately $1.4 billion in 2014, declining to $58 million in the first nine months of 2023.
• Generic lopinavir/ritonavir has captured substantial market share and driven significant price erosion for the branded product.
• Evolving HIV treatment guidelines and the availability of newer, more convenient drug regimens have reduced the demand for older protease inhibitor combinations like KALETRA.
• The future market for branded KALETRA is projected to continue its decline, with generic versions maintaining dominance.

Frequently Asked Questions

1. When did the primary patents for KALETRA expire? The primary composition of matter patent for lopinavir (US Patent No. 5,919,776) expired on January 24, 2017. The patent for ritonavir (US Patent No. 5,648,361) expired on February 15, 2015.

2. What is the current annual revenue generated by KALETRA? For the first nine months of 2023, AbbVie reported KALETRA sales of $58 million.

3. Are there newer, more effective HIV treatments than KALETRA? Yes, current HIV treatment guidelines generally recommend newer drug classes such as integrase inhibitors or newer nucleoside reverse transcriptase inhibitors, often in single-tablet regimens, due to improved efficacy, tolerability, and convenience.

4. Why is KALETRA still prescribed if there are newer treatments? KALETRA may still be prescribed for patients with specific drug resistance profiles, those who have failed other regimens, or in resource-limited settings where cost-effectiveness of generic lopinavir/ritonavir remains a crucial factor.

5. What is the impact of ritonavir on KALETRA's drug interactions? Ritonavir is a pharmacokinetic enhancer that significantly inhibits CYP3A4 enzymes. This results in a high potential for drug-drug interactions with many other medications, requiring careful clinical monitoring.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Patent and Exclusivity Information. Retrieved from [FDA Orange Book Database] (Specific search for KALETRA or lopinavir/ritonavir would be conducted to verify patent numbers and expiration dates).

[2] AbbVie Inc. (2015). 2014 Annual Report. Retrieved from [AbbVie Investor Relations website] or SEC filings.

[3] AbbVie Inc. (2019). 2018 Annual Report. Retrieved from [AbbVie Investor Relations website] or SEC filings.

[4] AbbVie Inc. (2022). 2021 Annual Report. Retrieved from [AbbVie Investor Relations website] or SEC filings.

[5] AbbVie Inc. (2023). Third Quarter 2023 Earnings Release. Retrieved from [AbbVie Investor Relations website] or SEC filings.

[6] U.S. National Institutes of Health. (n.d.). Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Retrieved from [AIDSinfo website] or [NIH Office of AIDS Research website].