SYMTUZA Drug Patent Profile

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

Symtuza is a drug marketed by Janssen Prods and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and twenty-three patent family members in forty-six countries.

The generic ingredient in SYMTUZA is cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Symtuza

Symtuza was eligible for patent challenges on November 5, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 26, 2026. This may change due to patent challenges or generic licensing.

There have been thirty-two 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 SYMTUZA

International Patents:	423
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
Drug Prices:	Drug price information for SYMTUZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYMTUZA
What excipients (inactive ingredients) are in SYMTUZA?	SYMTUZA excipients list
DailyMed Link:	SYMTUZA at DailyMed

See drug prices for SYMTUZA

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

NDA:

210455

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 SYMTUZA

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

Sponsor	Phase
East Carolina University	Phase 4
Imperial College London	Phase 3
Chelsea and Westminster NHS Foundation Trust	Phase 3

See all SYMTUZA clinical trials

Pharmacology for SYMTUZA

Drug Class	Cytochrome P450 3A Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase 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 Nucleoside Reverse Transcriptase Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

Paragraph IV (Patent) Challenges for SYMTUZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYMTUZA	Tablets	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	800 mg/150 mg/ 200 mg/10 mg	210455	1	2021-08-16

US Patents and Regulatory Information for SYMTUZA

SYMTUZA is protected by thirteen US patents.

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	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes			Y	Y

Expired US Patents for SYMTUZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018

International Patents for SYMTUZA

See the table below for patents covering SYMTUZA 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

Supplementary Protection Certificates for SYMTUZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1301519	2016/014	Ireland		PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061/001-EU/1/15/1061/002 20151119
0513200	91073	Luxembourg		91073, EXPIRES: 20160131
0513200	300148	Netherlands		300148, 20110131, EXPIRES: 20160130
0513200	SPC/GB04/016	United Kingdom		PRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024

SYMTUZA (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) market dynamics and financial trajectory: sales, pricing, competition, and exclusivity-driven risk

Last updated: July 21, 2026

SYMTUZA is a once-daily, fixed-dose combination antiretroviral regimen for HIV-1 treatment. Financial trajectory in the US is driven by (1) ongoing share shifts among single-tablet regimens (STRs) in treatment-naïve and virologically suppressed populations, (2) payor channel mechanics for branded STRs versus INSTI-based competitors, and (3) patent-exclusivity and generic entry risk for the darunavir/cobicistat backbone and the specific fixed-dose combination.

Below is the actionable market and financial framework for SYMTUZA, focused on competitive dynamics, exclusivity gates, and revenue exposure.

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What is SYMTUZA’s revenue trajectory and what market dynamics drive it?

Core drivers of sales

• HIV regimen migration: Treatment-naïve starts and switches trend toward INSTI-dominant STRs (e.g., bictegravir/TAF/emtricitabine; dolutegravir-based STRs), which affects SYMTUZA’s share even when clinical outcomes remain strong.
• Channel mix and rebate pressure: Branded HIV STRs compete through formulary placement, utilization management, and rebate structures. SYMTUZA pricing is typically shaped more by net price and mix than by list price.
• Persistency and switching: Once patients are on a stable regimen, uptake is slower unless side effects, drug-drug interaction concerns, pill tolerance, renal/hepatic management, or payer rules force changes.
• Geographic rollout: Non-US markets can swing revenue due to tender cycles, local patent landscapes, and generics competition timing.

Net revenue math that matters

• For HIV STRs, investors and litigators should track:
  • TRx growth vs patient retention (TRx often grows more slowly than new starts).
  • US gross-to-net spread (rebates rise as competitors add pressure).
  • Mix shift between treatment-naïve and “switched from other therapy” cohorts.
  • Formulary changes: a single large PBM or integrated delivery network decision can move volume quickly.

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How does SYMTUZA compare with other once-daily single-tablet HIV regimens on market share risk?

Direct competitive set (STRs) SYMTUZA competes primarily with other once-daily STRs that dominate guideline-concordant therapy pathways:

1. INSTI-based STRs
   • Bictegravir/TAF/emtricitabine (Biktarvy)
   • Dolutegravir/lamivudine (Dovato, though not TAF-based) and other INSTI backbones depending on label
2. Protease inhibitor (PI)-based STRs
   • Darunavir/cobicistat STR alternatives are structurally closest, but the market share impact often comes from whether payors prefer INSTI-heavy portfolios.

Market share mechanics

• Switching friction: Patients on SYMTUZA tend to remain if virologically suppressed and tolerating regimen. That reduces churn.
• Start friction: Payors and prescribers increasingly start INSTI regimens in naïve patients when clinically appropriate.
• Drug interaction profile: SYMTUZA’s cobicistat component drives interaction management, which can reduce initiation in patients on multiple concomitant medications and in populations with complex regimens.

Competitive takeaway SYMTUZA’s revenue resilience is linked to retention of suppressed patients and specific clinical niches where darunavir/cobicistat + NRTI backbones remain preferred. The largest long-run risk is new-start share loss if formularies weight INSTI STRs more heavily.

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What patents protect SYMTUZA and how many are in force in key geographies?

What to map in a patent estate For fixed-dose combination HIV products, practical exclusivity and patent protection typically come from:

• Composition-of-matter for combination ratios (darunavir + cobicistat + emtricitabine + TAF)
• Formulation and solid-state patents (film coating, particle size distribution, solid form)
• Method-of-use patents (specific HIV treatment regimens, patient subsets, or boosted PI regimens)
• Manufacturing method patents (process steps for forming the combination tablet)
• Any pediatric or specific extension patents, where applicable

How to interpret the estate for business risk

• If generics can file Paragraph IV certifications targeting the combination, the first generic “trigger” usually depends on whether the relevant claims are about the active combination itself versus about formulation/method details.
• For combination STRs, even when one API is off-patent, fixed-dose combination exclusivity can still delay generic entry.

Actionable portfolio gating In practice, litigation and FDA-Orange Book data decide whether a filer faces:

• Claim-by-claim non-infringement arguments (risk is reduced if claims are narrow)
• Validity attacks (risk is higher if prior art is strong but claim scope is broad)
• Settlement-to-avoid entry (delays commercial launch despite non-infringement arguments)

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When does SYMTUZA lose exclusivity in the US (Orange Book and regulatory exclusivity)?

Exclusivity framework for US launch risk There are two parallel levers:

1. Patent expiration listed in the FDA Orange Book for SYMTUZA
2. Regulatory exclusivity periods that can extend beyond patent expiration for certain submissions

For a fixed-dose STR, exclusivity loss timing is typically when:

• The last relevant composition/formulation/method-use patent expires in the US
• Or when a generic launch is permitted via resolution of a patent challenge or expiration without effective injunction

Business interpretation

• If the remaining Orange Book list contains at least one “combination claim” that is highly likely to be enforced, launch risk stays low until that claim expires or litigation ends.
• If a Paragraph IV filer can carve around formulation-specific patents, it may be able to launch sooner, even with some patents still pending.

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What is the Orange Book status of SYMTUZA and which listed patents are typically asserted?

How Orange Book data usually maps to enforcement For combination HIV STRs, asserted patents tend to cluster in:

• Combination claim classes covering the fixed-dose tablet
• Formulation-specific claim classes (solid state, release profile, stability-related properties)
• Use claim classes tied to therapy regimens

Actionable checklist for counsel or BD

• Identify the “last expiring” patents by patent term (including PTA, if any)
• Identify which are tied to combination composition versus formulation/process
• Cross-check which patents have been asserted in prior ANDA litigation in the class of products (to predict enforcement behavior)

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What Paragraph IV challenges affect SYMTUZA, and what settlement timelines are relevant?

How to measure Paragraph IV impact For revenue and pipeline planning, the key is not whether a Paragraph IV is filed, but:

• Whether an automatic stay was triggered
• Whether a consent judgment or settlement date sets an agreed-for-launch window
• Whether the generic is enjoined until a specific patent expires

Commercial consequences

• If SYMTUZA faces a Paragraph IV with a likely settlement, revenue impact can become visible in the quarter(s) following the agreed launch window.
• If the litigation resolves with an injunction or no settlement-to-launch, the impact can be delayed until the last relevant patent expires.

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What generic entry risks exist for SYMTUZA (manufacturing and IP barriers)?

Primary generic entry risks for fixed-dose STRs

• Bioequivalence vs fixed-dose formulation parity: Even with BE, formulation-specific patent claims can block launch.
• Solid-state and process patents: Different manufacturing routes can avoid some claims, but not if composition/formulation patents dominate.
• Regulatory constraints: If the label requires specific NRTI ratios or dosing instructions tied to the fixed-dose combination, the generic must match both pharmacokinetic and labeling requirements.
• Payer and contract behavior: Even when legal entry occurs, competitive penetration depends on formulary update timing and contracting.

Business implication The entry-risk profile for SYMTUZA is shaped by whether the patent estate is dominated by:

• Combination composition claims (high barrier), or
• Formulation/process details that a generic can design around (lower barrier)

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How does SYMTUZA’s biosimilar risk compare with other HIV products?

SYMTUZA is an HIV small-molecule fixed-dose combination. It has no biosimilar pathway. The competitive substitution risk is via ANDAs for generics and potential authorized generics, not via biosimilar development.

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What FDA and regulatory milestones define SYMTUZA’s competitive pacing?

Regulatory elements that affect timeline

• Approval history (initial NDA and later label expansions)
• Supplement approvals that can change what is protected by new patents (method-of-use or new patient subsets)
• Post-marketing regulatory commitments that can indirectly affect manufacturing readiness

Commercial relevance Regulatory supplements can change:

• Which patient subsets the product is most used for
• Whether generics can rely on narrow carve-outs
• Whether new patents attach to new methods or indications

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Which companies are challenging or competing with SYMTUZA, and what is their likely commercial posture?

Competition map

• Generic filers: ANDA applicants with Paragraph IV certifications, typically targeting the combination product and the key Orange Book patents.
• Branded competitors: INSTI-based STR manufacturers, which exert the largest pressure on new starts and formulary share.
• Authorized generic channels: sometimes used as a settlement lever in conjunction with patent outcomes.

Commercial posture indicators

• Generic challengers that win settlements usually launch quickly and pursue aggressive contracting.
• Branded competitors typically respond with rebate packages and formulary negotiation rather than patent disruption.

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How resilient is SYMTUZA’s revenue if patents expire first in the US vs outside the US?

Geographic mismatch risk

• US patent expiration does not eliminate competition if other markets already have generic availability.
• Conversely, if outside-US markets retain exclusivity longer, global revenue can remain cushioned until US entry.

Investor view For a multinational brand, the practical revenue hinge is:

• How much revenue is earned in markets where generics are already available
• Whether payors in the US use price normalization against lower-cost jurisdictions

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Key financial drivers to track for SYMTUZA (quarterly and annual)

Revenue and volume

• TRx growth rate
• Treatment-naïve vs suppressed-patient share
• Switch rate from other STRs, especially INSTI STRs

Pricing and profitability

• US net price per unit
• Gross-to-net ratio and its volatility during competitive events
• Contracting effects after formulary decisions

Regulatory and litigation

• Orange Book “last expiring” dates
• Status of any ANDA/Paragraph IV events and whether any automatic stays have been lifted
• Settlement milestones that set fixed launch windows

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Key Takeaways

• SYMTUZA’s financial trajectory is driven by retention of virologically suppressed patients plus payer contracting, while INSTI-based STRs pose the largest new-start share risk.
• Patent-driven generic entry risk depends on whether the Orange Book estate is dominated by combination composition claims versus formulation/process patents that can be designed around.
• Paragraph IV outcomes matter most when they convert into agreed-for-launch windows rather than case filings alone.
• SYMTUZA has no biosimilar pathway; substitution risk is via ANDAs and contracting, not biologics competition.
• Near-term planning should anchor to US exclusivity and patent expiration gates, plus quarter-by-quarter monitoring of US net price, TRx trends, and formulary share.

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FAQs

1) What are the main drivers of SYMTUZA share loss versus INSTI-based single-tablet regimens?
Shift in treatment-naïve prescribing toward INSTI-heavy pathways and payer formulary preferences, partially offset by patient retention when suppressed.

2) How does SYMTUZA’s cobicistat component affect competitive positioning?
It increases drug-drug interaction management needs, which can reduce initiation in complex medication profiles.

3) What determines whether an ANDA can launch SYMTUZA at US exclusivity expiration?
Whether the ANDA can resolve or design around the Orange Book-listed claims that cover the fixed-dose combination and any enforceable formulation/method-of-use patents.

4) What quarterly metrics best forecast SYMTUZA revenue turning points?
TRx growth, net price per unit, gross-to-net changes, and mix between naïve starts and suppressed-patient maintenance.

5) Does SYMTUZA face biosimilar competition?
No. It is a small-molecule fixed-dose drug, so competition is from generics via ANDAs rather than biosimilars.

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References

1. FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. Food and Drug Administration.
2. FDA. “ANDA Patent Certification Requirements and Procedures.” U.S. Food and Drug Administration.
3. FDA. “Drugs@FDA: FDA Approved Drug Products.” U.S. Food and Drug Administration.

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