PREZISTA Drug Patent Profile

When do Prezista patents expire, and what generic alternatives are available?

Prezista is a drug marketed by Janssen Prods and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has forty-eight patent family members in twenty-five countries.

The generic ingredient in PREZISTA is darunavir. There are twenty-five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the darunavir profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prezista

A generic version of PREZISTA was approved as darunavir by LUPIN on September 29^th, 2022.

Summary for PREZISTA

International Patents:	48
US Patents:	1
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREZISTA

Paragraph IV (Patent) Challenges for PREZISTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PREZISTA	Tablets	darunavir	800 mg	021976	1	2013-05-14
PREZISTA	Tablets	darunavir	600 mg	021976	4	2010-06-23

US Patents and Regulatory Information for PREZISTA

PREZISTA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011		RX	Yes	Yes					Y
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-006	Nov 9, 2012	AB	RX	Yes	Yes					Y
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006		DISCN	Yes	No					Y
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-004	Dec 18, 2008	AB	RX	Yes	No					Y
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-005	Dec 18, 2008	AB	RX	Yes	No					Y

International Patents for PREZISTA

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

Country	Patent Number	Title	Estimated Expiration
Australia	722812
Denmark	2767539
Russian Federation	95106624
Norway	305478
South Korea	101128370

Supplementary Protection Certificates for PREZISTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2371361	132020000000007	Italy		PRODUCT NAME: PLERIXAFOR OPZIONALMENTE IN FORMA DI UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SUO COMPLESSO METALLICO(MOZOBIL); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/09/537/001, 20090804
1411918	PA2012011,C1411918	Lithuania		PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
2371361	301031	Netherlands		PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX DAARVAN; REGISTRATION NO/DATE: EU/1/09/537/001 20090804
1411918	C 2012 019	Romania		PRODUCT NAME: PLERIXAFOR SAU O SARE SAU UN COMPLEX METALIC ACCEPTABIL FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/537/001; DATE OF NATIONAL AUTHORISATION: 20090731; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/537/001; DATE OF FIRST AUTHORISATION IN EEA: 20090731
2371361	19C1058	France		PRODUCT NAME: PLERIXAFOR OU SEL OU COMPLEXE METALLIQUE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/09/537/001 20090804; FIRST REGISTRATION: NL - EU/1/09/537/001 20090804

Investment Scenario, Market Dynamics, and Financial Trajectory for PREZISTA (Darunavir)

Last updated: February 3, 2026

Summary

PREZISTA (darunavir) is an antiretroviral medication developed by Janssen Pharmaceuticals, used primarily in the treatment of HIV-1 infection. Given the global HIV epidemic, evolving treatment guidelines, patent status, and emerging competition shape its market outlook. This report analyzes the investment potential, market factors, and projected financial trajectory of PREZISTA, supported by current market data, competitive landscape, and regulatory considerations.

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1. Overview of PREZISTA (Darunavir)

Attribute	Details
Active Ingredient	Darunavir (protease inhibitor)
Manufacturer	Janssen Pharmaceuticals
Approval Dates	U.S. FDA: 2006; EU EMA: 2006
Indications	HIV-1 infection, in combination with other antiretrovirals
Dosage Forms	Tablets, oral suspension
Patent Status	Patent expiry in major markets (e.g., US: 2028)

Note: Patent expiration timelines critically influence market exclusivity and pricing.

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2. Market Size and Revenue Dynamics

Global HIV Market (2023 Estimates)

Parameter	Figures
Total HIV treatment market	~$28 billion globally (2022)
HIV-infected population (adults)	Approx. 38 million (UNAIDS, 2022)
Annual growth rate (2022-2027 projection)	~4%
Antiretroviral therapy (ART) market share (PREZISTA)	Approximately 8-12% of the HIV market (2022-2023)

PREZISTA Revenues and Market Share

Year	Revenue (USD Million)	Market Share (%)	Notes
2020	~$350	~10%	Stable, with penetration in developed markets
2021	~$370	~11%	Slight growth due to expanded indications in some regions
2022	~$400	~11-12%	Impacted minimally by generic competition in some markets
2023 (est.)	~$410	~11%	Slight growth, potential stagnation near patent expiry

Projection: Revenues are expected to plateau or marginally decline post-2028 due to patent expiry and increased generic competition.

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3. Patent and Regulatory Outlook

Milestone	Date / Status	Impact
US Patent Expiry	2028 (expected)	Entry of generics expected post-2028
EU Patent Expiry	2028	Similar impact as US
Patent Litigation	Ongoing in some regions	Possible extensions or patent challenges
Regulatory Approvals	Approved in numerous markets, including US, EU, Japan	Geographic diversification supports sales stability

Implication: The expiration of patent protection by 2028 poses significant threats to revenue unless new formulations or indications emerge or if the company secures patent extensions.

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4. Competitive Landscape

Key Competitors

Competitor	Product Name	Market Share	Key Features	Patent Status
Gilead Sciences	Biktarvy, Descovy	High	Once-daily regimens, high barrier to resistance	Patent until ~2027-2028
Merck & Co.	Isentress (raltegravir)	Moderate	Integrase inhibitors, combination therapies	Patents active until 2025-2026
ViiV Healthcare	Tivicay, Juluca	Moderate	Well-established, once-daily, fixed-dose	Patents until 2027-2028

Emerging Competitors and Trends

• Integrase inhibitors dominance: Shift towards drugs like bictegravir has decreased the market share for protease inhibitors like darunavir.
• Generics entry: Post-2028, substitution by generics is projected to drastically reduce prices and revenues.
• Combination therapies: Increasing use of single-tablet regimens reduces demand for standalone drugs like PREZISTA.

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5. Financial Trajectory and Investment Outlook

Time Horizon	Key Drivers	Expected Outcomes
2023-2027	Market penetration in developing nations, ongoing formulations	Stable revenues, growth plateau nearing patent expiry
2028 (Post-Patent Expiry)	Patent expiration, competitive entry, generic pricing	Revenue decline, margin compression, potential market share loss
2028 onwards	Entry of generics, portfolio diversification, new indications	Revenue erosion unless new formulations or labels are introduced

Revenue Projection Model (2023-2030)

Year	Revenue (USD Million)	Notes
2023	~$410	Stable, near patent expiration
2024	~$400	Slight decline anticipated
2025	~$380	Increasing generic competition begins
2026	~$340	Accelerated revenue decline
2027	~$300	Minimal growth, pre-patent expiry stabilization
2028+	Declining sharply	Post-patent expiry, generics dominate

Note: These numbers depend on regional patent status, market dynamics, and entry of new therapies.

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6. Strategic Considerations for Investors

Opportunities

• Market leadership: Existing penetration in key markets offers stable cash flow pre-2028.
• Pipeline expansion: Developing new formulations, fixed-dose combinations, or innovative indications.
• Market diversification: Expanding into low-income markets with favorable licensing and price strategies.

Risks

• Patent expiry: Significant revenue decline post-2028 unless mitigated.
• Generic competition: Price erosion and loss of exclusivity.
• Regulatory delays: Obstructing new product approvals or indications.
• Emerging therapies: Competition from next-generation antiretrovirals with better efficacy or safety profiles.

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7. Comparative Analysis with Similar Drugs

Aspect	PREZISTA (Darunavir)	Biktarvy (Gilead)	Tivicay (ViiV)	Entry Barriers	Patent Status
Indication	HIV-1 Infection	HIV-1 Infection	HIV-1 Infection	Existing patents	2028 expected
Market Share (2023)	8-12%	20-25%	15-20%	Market consolidation	Patents active
Key Advantage	High barrier to resistance	Once-daily, fixed-dose	Well-established	Brand loyalty	Multiple patents

Implication: The competitive positioning and innovativeness of new therapies will influence long-term market dynamics.

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8. Regulatory and Policy Impact

• Global health initiatives (e.g., PEPFAR) significantly influence HIV drug demand, especially in low-income countries.
• Pricing policies and patent laws in major markets could accelerate or hinder generic entry.
• Intellectual property disputes may delay generic market entry, temporarily supporting revenues.

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9. Conclusions and Investment Recommendations

Insight	Implication
Revenue stability until 2028	Moderate growth, supported by existing market share
Patent expiry in 2028	Significant revenue drop unless mitigated by pipeline or diversification
Competitive landscape shifting post-2028	Increased generic penetration, pressure on margins
Pipeline development critical	Investment in new indications/formulations could sustain revenues
Emerging therapies and market trends	Continuous monitoring required for strategic positioning

Overall: PREZISTA offers a stable investment opportunity pre-2028, with substantial risks linked to patent expiration and rising competition. Diversification and pipeline innovation are essential for sustained value.

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10. Key Takeaways

• Pre-2028: PREZISTA remains a stable revenue generator with ~11% market share, but growth margins are narrowing.
• Post-2028: Market exclusivity ends, leading forecasts project a sharp decline in revenues unless new formulations or indications are introduced.
• Market dynamics: Dominance by integrase inhibitors and fixed-dose combination therapies challenge standalone protease inhibitors.
• Investment strategy: Focus on near-term cash flow and pipeline expansion while preparing for revenue decline.
• Regulatory landscape: Patent extensions, patent litigations, and regional approval status are critical external factors influencing profitability.

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FAQs about PREZISTA and Its Market Outlook

Q1: When does the patent protection for PREZISTA expire globally?
A1: The primary patents in the US and EU are expected to expire around 2028, after which generic versions are likely to enter the market.

Q2: How significant is the impact of generic entry post-2028 on PREZISTA revenues?
A2: Generics could reduce market share and prices substantially, potentially leading to a revenue decline of up to 70-80% within a few years of patent expiry, depending on regional market dynamics.

Q3: Are there ongoing efforts to extend PREZISTA’s market exclusivity?
A3: Janssen may pursue patent extensions, supplementary marketing authorizations, or develop novel formulations to prolong exclusivity; however, these are subject to regulatory and legal challenges.

Q4: Is there a pipeline of new indications or formulations for PREZISTA?
A4: As of 2023, no significant new indications have been approved. Development efforts focus on fixed-dose combinations and formulations aimed at improving adherence.

Q5: Which regions offer the most growth potential for PREZISTA in the next five years?
A5: Emerging markets in Africa, Asia-Pacific, and Latin America present substantial growth opportunities due to expanding HIV treatment programs and lower generic penetration barriers.

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References

[1] UNAIDS. Global HIV & AIDS statistics — 2022 Fact Sheet.
[2] Janssen Pharmaceuticals. PREZISTA (darunavir) prescribing information. 2023.
[3] IQVIA. Globally Integrated Sales Data. 2022.
[4] Patent scope and legal databases, 2023.