PREZCOBIX Drug Patent Profile

When do Prezcobix patents expire, and when can generic versions of Prezcobix launch?

Prezcobix is a drug marketed by Janssen Prods and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and fifty-four patent family members in forty-one countries.

The generic ingredient in PREZCOBIX is cobicistat; darunavir ethanolate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cobicistat; darunavir ethanolate profile page.

DrugPatentWatch^® Generic Entry Outlook for Prezcobix

Prezcobix was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 26, 2027. This may change due to patent challenges or generic licensing.

There have been fifteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for PREZCOBIX

International Patents:	354
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	103
Drug Prices:	Drug price information for PREZCOBIX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREZCOBIX
What excipients (inactive ingredients) are in PREZCOBIX?	PREZCOBIX excipients list
DailyMed Link:	PREZCOBIX at DailyMed

See drug prices for PREZCOBIX

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PREZCOBIX

Constraining patent/regulatory exclusivity:

7,700,645*PED

NDA:

205395

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PREZCOBIX

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

Sponsor	Phase
Janssen Pharmaceutical K.K.	Phase 4
Stanford University	Phase 2/Phase 3
University of Colorado, Denver	Phase 2/Phase 3

See all PREZCOBIX clinical trials

Pharmacology for PREZCOBIX

Drug Class	Cytochrome P450 3A Inhibitor Protease Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for PREZCOBIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PREZCOBIX	Tablets	cobicistat; darunavir ethanolate	800 mg/150 mg	205395	1	2020-07-24

US Patents and Regulatory Information for PREZCOBIX

PREZCOBIX is protected by five US patents.

This potential generic entry date is based on patent 7,700,645.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-002	Mar 21, 2025		RX	Yes	Yes	8,148,374		Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	10,039,718		Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	8,148,374		Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	7,700,645*PED				Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-002	Mar 21, 2025		RX	Yes	Yes	10,039,718		Y

Expired US Patents for PREZCOBIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	9,889,115

EU/EMA Drug Approvals for PREZCOBIX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Rezolsta	darunavir, cobicistat	EMEA/H/C/002819Rezolsta, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years or older.Genotypic testing should guide the use of Rezolsta.	Authorised	no	no	no	2014-11-19

International Patents for PREZCOBIX

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

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	3089
African Regional IP Organization (ARIPO)	3250
Argentina	075369
Australia	2009242451
Australia	2010210598

Supplementary Protection Certificates for PREZCOBIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0810209	07C0034	France		PRODUCT NAME: DARUNAVIR; REGISTRATION NO/DATE: EU/1/06/380/001 20070212
0810209	CA 2007 00017	Denmark		PRODUCT NAME: DARUNAVIR OG ET FARMACEUTISK ACCEPTABELT SALT DERAF
0810209	SPC/GB07/038	United Kingdom		PRODUCT NAME: DARUNAVIR OR THE PHARMACEUTICALLY ACCEPTABLE SALT, ESTER OR PRODRUG THEREOF; REGISTERED: UK EU/1/06/380/001 20070212; SPC EXTENSION AUTHORISATION: EU/1/06/380/001 - 008, 20070212
0810209	2007/024	Ireland
0810209	SPC024/2007	Ireland		SPC024/2007: 20081105, EXPIRES: 20180823

Last updated: July 23, 2026

PREZCOBIX (darunavir/cobicistat) Market Dynamics, Pricing, and Financial Trajectory (US and Key EU/ROW)

Executive summary: PREZCOBIX (darunavir 800 mg + cobicistat 150 mg) remains a branded anchor in HIV protease inhibitor therapy where once-daily protease regimens still fit clinician practice, but its growth profile is capped by mature class penetration and ongoing HIV treatment line-shift to INSTI-based combinations. Financial performance is driven by (1) share retention vs. other protease inhibitor regimens, (2) managed-care and national formulary placement, (3) patient access in treatment-naïve and switch settings, and (4) competitive pressure from newer, higher-barrier-to-resistance regimens and the secular shift away from protease inhibitor-heavy prescribing.

How has PREZCOBIX performed financially since launch, and what trajectory does the market imply?

Direct accounting trajectory (what typically moves revenue):
For an older HIV branded product like PREZCOBIX, revenue trajectory is usually shaped by four forces:

1. Formulary access and rebilling dynamics: net price can fall even if gross price holds due to rebates, copay support, and payer preference.
2. Mix shift within protease inhibitor space: patient switching tends to reduce share among fragmented subpopulations (treatment-naïve, treatment-experienced, renal-function constrained, adherence drivers).
3. Class substitution: INSTI-based regimens continue to absorb growth and switch demand.
4. Regional competitive intensity: generics in many markets pressure net price and limit brand duration absent strong protected advantage, limited substitutability, or specific clinician preference for boosted darunavir.

What the financial shape usually looks like (market mechanics):

• Early maturity: PREZCOBIX adoption tends to plateau after initial switch from older boosted protease inhibitor schedules.
• Mid-term decline or stagnation: revenue often tracks slow erosion from class substitution and generic/therapeutic alternatives.
• Late-stage stabilization: when the brand becomes the “default” boosted darunavir for a subset (stable suppression, intolerance to alternatives, simplified dosing), revenue can stabilize even as total HIV market grows.

What market dynamics determine PREZCOBIX demand: prescribing patterns, line of therapy, and payer access?

Does PREZCOBIX sell more in treatment-naïve or switch patients?

PREZCOBIX demand is typically concentrated in switch and maintenance settings inside protease inhibitor frameworks because:

• clinician familiarity and long clinical track record support continuation for virologically suppressed patients;
• protease inhibitors retain a role when resistance history or comorbid constraints limit INSTI options.

How do formularies and managed care affect net revenue for PREZCOBIX?

Net revenue for mature HIV brands is usually less about list price and more about:

• preferred drug status within HIV formularies;
• therapeutic interchange rules (ability of payers to move patients between boosted protease options);
• prior authorization and step therapy requirements;
• rebate pressure as generic/biosimilar-like competitive logic spreads across HIV segments.

Where does PREZCOBIX face the biggest competitive substitution?

Competitive substitution risks generally come from:

• INSTI-based single-tablet regimens used as first-line anchors;
• other boosted protease inhibitor options within the class where payer contracting favors them;
• non-boosted or alternative pharmacokinetic profiles for patients with comorbidity-driven constraints.

How do pricing and discounting dynamics work for mature HIV brands like PREZCOBIX?

Is PREZCOBIX exposed to generic substitution pressure?

Yes, mature molecules in HIV face generic and therapeutic substitution pressure depending on jurisdiction. The practical market effect is:

• brand net price compresses through rebate and contracting;
• demand shifts to where brand remains “least-burden” for prescribers and patients.

What is the likely impact of Medicaid and large PBM contracting on PREZCOBIX?

For established HIV brands, large contracting ecosystems tend to:

• intensify reimbursement via preferred lists and rebate aggregation;
• reduce brand share via step edits and switching incentives when lower-cost therapeutic equivalents are available.

Which therapeutic competitors most affect PREZCOBIX share, and how does PREZCOBIX compare?

Protease inhibitor peers

Within the boosted protease inhibitor category, competitive positioning depends on:

• dosing convenience and resistance profile consistency;
• tolerability and comedication burden;
• payer preference for contracted agents.

INSTI-based regimens

The dominant market shift for HIV is toward INSTI-based regimens. That affects PREZCOBIX by:

• reducing incremental first-line growth for protease inhibitors;
• increasing switching when patients initiate or restart therapy.

What is the financial risk profile for PREZCOBIX: volume erosion vs. margin compression?

The two main risks:

1. Volume erosion: steady share loss as clinicians and guidelines prioritize INSTI-based options.
2. Margin compression: even if volume holds, net price can fall as payer contracting tightens.

How to read the market:

• If volume declines faster than the net price, substitution is the driver.
• If volume holds but revenue declines, net price compression is the driver.

What regulatory and exclusivity factors shape PREZCOBIX’s commercial trajectory?

FDA regulatory status and labeling maturity

PREZCOBIX has a mature US labeling posture, which supports clinician confidence but does not prevent substitution when more market-favorable regimens are available.

Patent and exclusivity effects on business planning

For long-established HIV drugs, exclusivity and patent positioning typically drives the window before accelerated erosion through generics and contract repricing. That business risk is normally front-loaded earlier in the lifecycle, then becomes a continuous pressure once alternatives are available.

How do geographic market dynamics differ for PREZCOBIX (US vs EU/UK and ROW)?

US

US dynamics are shaped by:

• PBM contracting and formulary placement across major plans;
• Medicaid utilization patterns;
• generic and therapeutic substitution exposure in specific plan designs.

EU and UK

EU patterns typically reflect:

• national HTA decisions and reimbursement controls;
• pricing frameworks and periodic tendering;
• differences in generics uptake speed by market.

What does the competitive landscape imply for PREZCOBIX unit demand going forward?

Base-case market implication for an older HIV protease inhibitor brand:

• growth is unlikely to resume as a driver product in a category dominated by INSTI-based regimens;
• the brand’s realistic path is stabilization or modest decline, with revenue depending on the strength of switch/maintenance retention and contracting terms.

PREZCOBIX financial trajectory scenarios (business-use framing)

Scenario 1: Continued stabilization

Assumptions: strong maintenance usage, limited payer preference shifts, slow switching to alternatives in protease-appropriate patients.
Business impact: revenue stabilizes while overall HIV market grows.

Scenario 2: Slow erosion

Assumptions: gradual formulary preference change and incremental INSTI uptake in switch populations.
Business impact: revenue declines at a slower rate than underlying demand, driven by partial net price protection.

Scenario 3: Faster erosion

Assumptions: contracting-driven displacement in large payer groups and accelerated therapeutic switching.
Business impact: revenue declines faster due to both volume and net price pressure.

Key Key performance indicators to monitor for PREZCOBIX (what moves the P&L)

• Total HIV spend share within boosted protease or broader HIV protease subsegments
• Net price trend (rebates, copay adjustments, contracting terms)
• PBM preferred list placement changes
• Prescription volume trend split by naïve vs switch (where available)
• Channel mix (hospital vs retail vs specialty distribution)
• Patient retention metrics (persistence on regimen, switching rates)

Key Takeaways

• PREZCOBIX’s commercial trajectory is a mature-brand profile: demand is constrained by class substitution toward INSTI regimens and shaped by payer contracting and net price compression.
• Business risk is dominated by volume erosion and margin pressure rather than major regulatory discontinuity.
• Forward revenue performance depends on the durability of switch and maintenance use in protease-appropriate patient groups and on formulary and PBM positioning in the US and reimbursement frameworks abroad.

FAQs

1. What payer contracting metrics best predict PREZCOBIX revenue decline?
2. How does INSTI uptake typically impact boosted protease inhibitor switching behavior?
3. What is the usual pattern of net price erosion for mature HIV brands like PREZCOBIX?
4. Which patient subgroups are most likely to remain on PREZCOBIX long term?
5. How do differences in HTA/reimbursement timing across EU countries affect PREZCOBIX uptake?

References

1. (No sources were provided in the prompt.)

DrugChatter Q&A for PREZCOBIX

Prezcobix online pharmacy?