Darunavir - Generic Drug Details

What are the generic drug sources for darunavir and what is the scope of freedom to operate?

Darunavir is the generic ingredient in two branded drugs marketed by Janssen Prods, Amneal, Annora Pharma, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Hetero Labs Ltd Iii, Lupin, MSN, Mylan, Teva Pharms Usa, and Zydus Lifesciences, and is included in thirteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fourteen suppliers are listed for this compound. There are nine tentative approvals for this compound.

Summary for darunavir

International Patents:	48
US Patents:	1
Tradenames:	2
Applicants:	12
NDAs:	13
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	96
Clinical Trials:	226
Patent Applications:	7,936
Drug Prices:	Drug price trends for darunavir
What excipients (inactive ingredients) are in darunavir?	darunavir excipients list
DailyMed Link:	darunavir at DailyMed

See drug prices for darunavir

Recent Clinical Trials for darunavir

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

Sponsor	Phase
SolidarMed	PHASE3
Instituto Nacional de Sade, Mozambique	PHASE3
Muhimbili University of Health and Allied Sciences	PHASE3

See all darunavir clinical trials

Generic filers with tentative approvals for DARUNAVIR

Applicant	Application No.	Strength	Dosage Form
		400MG	TABLET;ORAL
		150MG	TABLET;ORAL
		600MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for darunavir

Drug Class	Protease Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for darunavir

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DARUNAVIR

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 darunavir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	DARUNAVIR	darunavir	TABLET;ORAL	211578-001	Nov 28, 2023	AB	RX	No	No
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-006	Nov 9, 2012	AB	RX	Yes	Yes	7,700,645*PED				Y
Cipla	DARUNAVIR	darunavir	TABLET;ORAL	206288-001	Nov 28, 2023	AB	RX	No	No
Mylan	DARUNAVIR	darunavir	TABLET;ORAL	202136-001	Jul 22, 2025	AB	RX	No	No
Lupin	DARUNAVIR	darunavir	TABLET;ORAL	202073-001	Sep 29, 2022	AB	RX	No	No

Expired US Patents for darunavir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006	5,583,131
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006	6,987,102

EU/EMA Drug Approvals for darunavir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Darunavir Mylan	darunavir	EMEA/H/C/004068Darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection (see section 4.2).Darunavir Mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1).Darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. Darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.2). Darunavir Mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART)-naïve (see section 4.2). ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10⁶/L. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).	Authorised	yes	no	no	2017-01-03
Janssen-Cilag International NV	Prezista	darunavir	EMEA/H/C/000707PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight.PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).In deciding to initiate treatment with PREZISTA co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection.PREZISTA 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:For the treatment of HIV 1 infection in antiretroviral treatment (ART) experienced adult patients, including those that have been highly pre treated.For the treatment of HIV 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.In deciding to initiate treatment with PREZISTA co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA.PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection.PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).PREZISTA 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (ART) naïve.ART experienced with no darunavir resistance associated mutations (DRV RAMs) and who have plasma HIV 1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/L. In deciding to initiate treatment with PREZISTA in such ART experienced patients, genotypic testing should guide the use of PREZISTA.	Authorised	no	no	no	2007-02-11
KRKA, d.d., Novo mesto	Darunavir Krka d.d.	darunavir	EMEA/H/C/004891400mg and 800 mg Film-coated TabletsDarunavir Krka d.d., co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.Darunavir Krka d.d., co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection in adult patients (see section 4.2).Darunavir Krka d.d. 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (ART)-naïve (see section 4.2).ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).600mg Film-coated TabletsDarunavir Krka d.d., co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.Darunavir Krka d.d. 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir.	Withdrawn	yes	no	no	2018-01-18
KRKA, d.d., Novo mesto	Darunavir Krka	darunavir	EMEA/H/C/004273400 and 800 mgDarunavir Krka, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.Darunavir Krka 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (ART)-naïve (see section 4.2).ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).600 mg Darunavir Krka, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection.Darunavir Krka 600 mg tablets may be used to provide suitable dose regimens (see section 4.2):For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated.For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight.In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir.	Authorised	yes	no	no	2018-01-26

International Patents for darunavir

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	2052	Pseudopolymorphic forms of HIV protease inhibitor
Australia	2003271740	PSEUDOPOLYMORPHIC FORMS OF A HIV PROTEASE INHIBITOR
Australia	2012205289	Pseudopolymorphic forms of a HIV protease inhibitor
Brazil	0311176	Formas pseudopolimórficas de um inibidor da protease do hiv
Brazil	PI0311176	pseudopolimorfo na forma de etanolato, seu uso, processo de preparação do mesmo e composição farmacêutica

Supplementary Protection Certificates for darunavir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487162	201640054	Slovenia		PRODUCT NAME: COBICISTAT OR PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVAT THEREOF AND DARUNAVIR OR PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVAT THEREOF, ESPECIALLY DARUNAVIR ETHANOLATE; NATIONAL AUTHORISATION NUMBER: EU/1/14/967/001; DATE OF NATIONAL AUTHORISATION: 20141119; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2487162	CA 2017 00002	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF OG DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIRETHANOLAT; REG. NO/DATE: EU/1/14/967/001 20141121
3150586	18/2020	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, DARUNAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT, UND EMTRICITABIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/17/1225 20170925
3150586	PA2020508,C3150586	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921
2487162	2016C/068	Belgium		PRODUCT NAME: COBICISTAT ET DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967 20141121

Darunavir Market Dynamics, Financial Trajectory, Patent Protection and Generic Risk

Last updated: September 8, 2026

Darunavir is a mature HIV-1 protease inhibitor with durable clinical value but declining branded economics. Its high genetic barrier to resistance supports continued use in treatment-experienced patients, salvage regimens and selected first-line settings. The commercial franchise has shifted from standalone Prezista to fixed-dose combinations, particularly Symtuza and Prezcobix. Revenue pressure comes from integrase inhibitors, generic darunavir, price erosion, and the expiration of core composition-of-matter protection.

What is darunavir and how is it marketed?

Darunavir is a protease inhibitor developed by Tibotec, later acquired by Johnson & Johnson. It is marketed primarily through Janssen Pharmaceuticals under several products:

Product	Components	Primary commercial role
Prezista	Darunavir	Standalone protease inhibitor, administered with ritonavir or cobicistat
Prezcobix	Darunavir/cobicistat	Fixed-dose two-drug regimen
Rezolsta	Darunavir/cobicistat	European and international equivalent to Prezcobix
Symtuza	Darunavir/cobicistat/emtricitabine/tenofovir alafenamide	Complete once-daily single-tablet regimen

The U.S. Food and Drug Administration approved Prezista in 2006 for treatment-experienced adults with HIV-1 infection. FDA later expanded use to treatment-naive patients and pediatric populations. Prezcobix was approved in 2015, while Symtuza received approval in 2018 (FDA, 2006, 2015, 2018).

Darunavir is pharmacologically differentiated by a high barrier to resistance. That property remains commercially relevant even as integrase strand transfer inhibitors have become the preferred backbone of most initial HIV treatment regimens.

How large is the darunavir market?

The market is divided between branded Janssen products in higher-income markets and generic darunavir, often supplied through public-health and tender channels in lower-income countries.

The relevant revenue base is larger than standalone Prezista sales because darunavir is embedded in multiple products. Public company reporting typically separates individual brands but does not provide a complete global revenue figure for the active ingredient across all formulations, licensees and generic suppliers.

The commercial market has three layers:

1. Standalone Prezista, which is the most exposed to generic substitution and legacy prescribing decline.
2. Prezcobix and Rezolsta, which retain value through boosted fixed-dose delivery.
3. Symtuza, which has the strongest branded positioning because it is a complete once-daily single-tablet regimen.

Symtuza competes with complete regimens based on bictegravir, dolutegravir and rilpivirine. Biktarvy, Dovato, Triumeq and other integrase-based products generally have stronger first-line positioning in U.S. and European treatment guidelines.

What is the financial trajectory for darunavir and Prezista?

The branded darunavir franchise has entered a late-life-cycle phase. Janssen’s reported HIV revenue has declined as patient switching, generic competition and lower pricing offset demand for combination products.

Revenue drivers

The financial trajectory reflects five forces:

• Declining standalone Prezista demand.
• Continued sales of Symtuza and Prezcobix.
• Lower treatment share relative to integrase inhibitors.
• Generic price competition outside protected branded markets.
• Stable demand from patients with resistance, prior treatment failure or limited regimen options.

Janssen parent Johnson & Johnson reports product sales by brand in annual filings, but reporting treatment varies by year and geography. The company has not consistently disclosed a consolidated darunavir-active-ingredient revenue figure covering Prezista, Prezcobix, Symtuza and international products.

A directional lifecycle view is:

Period	Financial position	Principal driver
2006-2012	Growth and expansion	Prezista adoption in treatment-experienced patients
2013-2017	Mature branded franchise	Broader use and development of boosted combinations
2018-2020	Product mix transition	Symtuza launch and movement away from standalone Prezista
2021-2024	Declining mature franchise	Integrase competition, generic pressure and price erosion
2025 onward	Late-life-cycle economics	Combination-product retention and geographic generic exposure

Symtuza is more economically resilient than Prezista because its single-tablet formulation improves adherence and creates a differentiated branded product. Its commercial ceiling is limited by treatment guidelines that favor integrase inhibitors for most newly diagnosed patients.

When does darunavir lose exclusivity?

Darunavir’s core composition-of-matter patent protection has expired or reached the end of its U.S. term, leaving formulation, combination, method-of-use and pediatric protections as the more relevant barriers.

The original darunavir compound patent is commonly identified as U.S. Patent No. 6,248,775. Its term was subject to statutory patent-term adjustment and pediatric exclusivity considerations. The principal composition protection did not provide a long-duration barrier comparable to the later formulation and combination patents that support Symtuza and Prezcobix.

Exclusivity must be analyzed by product rather than by active ingredient:

Product	Core protection issue	Commercial consequence
Prezista	Compound and formulation protection largely aged	Highest generic substitution risk
Prezcobix	Darunavir/cobicistat combination and formulation claims	Generic competition depends on approved product scope
Symtuza	Multicomponent combination and formulation claims	More complex abbreviated-approval pathway
Generic darunavir	Active ingredient and dosage-form availability	Lowers price and expands tender access

A drug’s active-ingredient patent expiry does not automatically eliminate protection for every fixed-dose product. Generic applicants can challenge listed patents, design around formulation claims or seek approval for a narrower product.

What patents protect darunavir formulations and combinations?

The relevant patent estate has several technical categories.

Darunavir composition and use patents

Early patents cover the chemical compound, its stereochemistry and antiviral use. These patents established the original regulatory moat but are now old relative to the product’s launch date.

Boosted formulations

Darunavir requires pharmacokinetic boosting in standard clinical use. Ritonavir was the original booster, while cobicistat supports Prezcobix and Symtuza. Patents covering coformulation, dosage ratios, excipients, dissolution and stability can create barriers separate from the darunavir molecule.

Symtuza formulation patents

Symtuza combines four active ingredients:

• Darunavir
• Cobicistat
• Emtricitabine
• Tenofovir alafenamide

Its patent position is technically more complex than standalone darunavir because an applicant must address the combination, tablet composition, stability and manufacturing process. The product also benefits from the established commercial value of a complete single-tablet regimen.

Method-of-use patents

Method claims may cover once-daily dosing, treatment of HIV infection, use in treatment-naive or treatment-experienced patients, and specific patient populations. Method-of-use patents can support litigation against a generic applicant that seeks a label containing the patented indication.

The practical strength of method patents depends on the scope of the approved label, the generic’s proposed carve-outs and the likelihood that physicians will prescribe the product for the patented use.

What is the Orange Book status of darunavir?

FDA’s Orange Book lists approved drug products, patent information and regulatory exclusivity data. The relevant records include Prezista and fixed-dose darunavir products, but Orange Book status must be reviewed by product, dosage form and strength rather than inferred from the molecule alone (FDA, n.d.-a).

Orange Book analysis should separate:

• Listed patents for the reference listed drug.
• Patent expiration dates.
• Pediatric exclusivity extensions.
• Certified Paragraph IV challenges.
• Approval dates for abbreviated new drug applications.
• Whether a patent has been delisted, expired or removed from active regulatory relevance.

For darunavir, the core business issue is that the original molecule is no longer an effective standalone barrier to generic competition. The remaining commercial value depends on whether formulation and combination patents delay or restrict substitution for Prezcobix and Symtuza.

Which companies are challenging darunavir exclusivity?

Generic manufacturers have commercial incentives to pursue darunavir because the active ingredient is established, clinically validated and suitable for high-volume public-health procurement.

Potential competitors include manufacturers that supply antiretroviral medicines through U.S. generic channels, European markets, national tenders and global access programs. However, the competitive set differs by product:

• Generic darunavir tablets face the lowest technical barrier.
• Darunavir/cobicistat products require more complex formulation work.
• Symtuza substitutes must reproduce a four-drug fixed-dose combination and satisfy bioequivalence requirements.
• International suppliers may compete through WHO prequalification or national regulatory approval without entering the U.S. market.

A Paragraph IV certification can trigger patent litigation under the Hatch-Waxman framework. The litigation risk is highest where a generic applicant seeks approval before the expiration of a listed formulation or method-of-use patent. A Paragraph IV filing does not prove that a generic will launch or that the challenged patent will be invalidated.

What is the FDA regulatory status of darunavir?

Darunavir is an FDA-approved antiretroviral active ingredient with multiple approved dosage forms and combination products. The FDA-approved labels require attention to:

• Use with a pharmacokinetic enhancer.
• Drug-drug interactions involving CYP3A.
• Contraindicated medicines.
• Hepatic impairment.
• Pediatric dosing.
• Pregnancy and reproductive considerations.
• Food administration requirements.

Symtuza and Prezcobix are regulated as fixed-dose combination products. Their clinical and regulatory value is linked to the full combination, not only to darunavir’s protease-inhibition activity.

The main regulatory risk is not withdrawal or safety-driven loss of market access. It is gradual displacement by newer regimens with simpler interaction profiles and stronger guideline preference.

How strong is the darunavir patent estate?

The patent estate is strong for technical complexity but weak as a broad, molecule-level exclusivity barrier.

Patent category	Relative strength	Reason
Original compound patent	Low	Mature and expired or near-expired protection
Standalone tablet claims	Low to moderate	Generic dosage-form competition is established
Darunavir/cobicistat claims	Moderate	Combination and formulation complexity
Symtuza formulation claims	Moderate to strong	Four-drug product and manufacturing constraints
Method-of-use claims	Moderate	Scope depends on label and carve-out strategy
Manufacturing and process claims	Moderate	Can increase entry cost but rarely block all substitution

The strongest remaining barriers are product-specific rather than molecule-wide. A competitor can often enter with generic darunavir while facing a separate technical and legal pathway for Symtuza substitution.

What generic launch scenarios exist for darunavir?

Three scenarios are commercially relevant.

Scenario 1: Standalone generic entry

Generic darunavir produces the fastest price erosion in markets where substitution is permitted. This scenario affects Prezista most directly and can accelerate prescriber movement toward lower-cost regimens.

Scenario 2: Limited combination-product entry

Generic darunavir/cobicistat enters selected jurisdictions, but a fully substitutable Symtuza equivalent remains unavailable. Janssen retains value through adherence, convenience and complete-regimen positioning.

Scenario 3: Broad fixed-dose combination erosion

A generic or authorized generic equivalent reaches major markets after patent settlement, invalidation or expiry. This would place direct pressure on Symtuza and could materially reduce the branded franchise.

The third scenario has the largest revenue impact, but it also faces the highest formulation, bioequivalence, manufacturing and regulatory hurdles.

How does darunavir compare with competing HIV drugs?

Attribute	Darunavir	Bictegravir	Dolutegravir	Rilpivirine
Drug class	Protease inhibitor	Integrase inhibitor	Integrase inhibitor	NNRTI
Resistance barrier	High	High	High	Lower than darunavir
Typical role	Treatment-experienced and selected initial therapy	Preferred complete regimen	Preferred backbone	Selected patients
Drug interactions	Significant due to boosting	Lower	Moderate	Food and interaction restrictions
Commercial maturity	Mature	Growth-to-mature	Mature	Mature
Main commercial risk	Generic erosion and share loss	Competitive crowding	Price and generic pressure	Narrower patient fit

Darunavir retains clinical relevance where resistance history limits integrase-based options or where a high resistance barrier is required. It is less competitive for uncomplicated initial therapy because boosted regimens create interaction, dosing and tolerability burdens.

What revenue exposure remains for Johnson & Johnson?

Johnson & Johnson’s exposure is concentrated in branded formulations, not the universal market for darunavir. Revenue sensitivity depends on:

• Symtuza’s share of the company’s HIV portfolio.
• The pace of generic entry into standalone darunavir.
• The timing of generic or authorized-generic combination products.
• U.S. Medicaid and government pricing.
• European tender erosion.
• Treatment guideline shifts.
• Patient retention among treatment-experienced populations.

Standalone Prezista has the highest decline risk. Symtuza is the principal product capable of extending branded revenue, although its long-term growth is constrained by integrase-based alternatives.

The portfolio remains strategically useful even with declining revenue because manufacturing, clinical data, physician familiarity and distribution infrastructure are established. Its value is more consistent with cash generation and lifecycle management than with high-growth pharmaceutical economics.

What litigation and settlement issues affect darunavir?

Darunavir litigation risk is concentrated in abbreviated-application challenges to Orange Book-listed patents. Key legal questions include:

• Whether a generic applicant made a Paragraph IV certification.
• Whether the reference sponsor filed suit within the statutory period.
• Whether the challenged claims cover the proposed generic label.
• Whether the applicant carved out patented methods of use.
• Whether a settlement includes a licensed launch date.
• Whether the settlement involves an authorized generic.

No single patent date determines the commercial launch date for all darunavir products. Product-level settlements, regulatory exclusivity, patent validity decisions and formulation-specific claims can produce different entry dates.

What manufacturing and geographic barriers remain?

Darunavir manufacturing is technically established, but combination products create higher operational demands. Manufacturers must control:

• Active-ingredient purity and polymorphism.
• Tablet compression and dissolution.
• Stability of multiple actives.
• Cobicistat compatibility.
• Bioequivalence across the full combination.
• Supply-chain reliability for global tenders.

Geographic economics differ sharply. In the United States, patent listings and substitution rules determine entry. In Europe, national reimbursement and tender systems accelerate price competition. In low- and middle-income countries, voluntary licensing, procurement programs and donor-funded purchasing can make generic darunavir available at prices far below branded levels.

Key Takeaways

• Darunavir is a mature HIV product with persistent clinical value but declining branded-market share.
• Prezista is the most exposed product because standalone molecule protection has aged.
• Symtuza and Prezcobix extend the franchise through combination and formulation differentiation.
• Integrase inhibitors are the primary competitive threat in treatment-naive patients.
• Generic darunavir creates immediate price pressure, while generic Symtuza presents the larger long-term revenue risk.
• The remaining patent estate is strongest around formulations, combinations and manufacturing rather than the active molecule.
• Johnson & Johnson’s financial exposure is concentrated in branded combination products and legacy HIV cash flows.
• Commercial performance will depend more on lifecycle management and resistance-driven demand than on broad treatment-market expansion.

FAQs

Is darunavir still under patent protection?

The original darunavir compound protection has reached the end of its effective commercial life in major markets. Product-specific formulation, combination and method-of-use patents can remain relevant for individual products.

Is Symtuza the same as Prezista?

No. Prezista contains darunavir, while Symtuza is a complete four-drug fixed-dose combination containing darunavir, cobicistat, emtricitabine and tenofovir alafenamide.

Can a generic manufacturer substitute darunavir for Symtuza?

No. A generic darunavir product is not automatically substitutable for Symtuza. The manufacturer must obtain approval for the relevant fixed-dose combination and satisfy applicable bioequivalence and labeling requirements.

Why does darunavir remain important despite integrase inhibitors?

Darunavir has a high resistance barrier and remains useful for treatment-experienced patients, patients with resistant virus and cases where prior regimen history limits other options.

What is the biggest commercial risk to the darunavir franchise?

The largest risk is combined erosion from integrase-inhibitor preference and generic fixed-dose combination entry, particularly if a broadly substitutable Symtuza equivalent reaches major markets.

References

1. Food and Drug Administration. (2006). FDA approves Prezista for treatment of HIV infection. https://www.fda.gov
2. Food and Drug Administration. (2015). Prezcobix prescribing information. https://www.accessdata.fda.gov
3. Food and Drug Administration. (2018). Symtuza prescribing information. https://www.accessdata.fda.gov
4. Food and Drug Administration. (n.d.-a). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
5. Johnson & Johnson. (2019-2024). Annual reports and Form 10-K filings. https://www.jnj.com/investor-relations
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