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 twenty-seven 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

Constraining patent/regulatory exclusivity:

7,700,645

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
Chelsea and Westminster NHS Foundation Trust	Phase 3
Imperial College London	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.

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	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	8,754,065		Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	10,786,518
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	10,039,718		Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	9,296,769		Y	Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	8,148,374		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	8,597,876
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	7,390,791
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	6,642,245
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	8,518,987
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018	7,470,506

International Patents for SYMTUZA

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

Country	Patent Number	Title	Estimated Expiration
South Africa	9201251
Austria	361293
World Intellectual Property Organization (WIPO)	9215308
Germany	69232649
Canada	2845553

Supplementary Protection Certificates for SYMTUZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487162	C20170003 00221	Estonia		PRODUCT NAME: DARUNAVIIR/KOBITSISTAAT;REG NO/DATE: EU/1/14/967 21.11.2014
2487166	17C1001	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET TENOFOVIR ALAFENAMIDE SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
1301519	PA2016009	Lithuania		PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
2049506	201540054	Slovenia		PRODUCT NAME: COBICISTAT OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NATIONAL AUTHORISATION NUMBER: EU/1/13/830/001-002; DATE OF NATIONAL AUTHORISATION: 20130524; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2487166	PA2016038	Lithuania		PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119

Market Dynamics and Financial Trajectory for SYMTUZA

Last updated: February 20, 2026

SYMTUZA (darunavir/cobicistat) is an antiretroviral therapy (ART) approved by the U.S. Food and Drug Administration (FDA) in 2020 for the treatment of adults with HIV-1 infection. As a fixed-dose combination, SYMTUZA offers a treatment option for HIV management. Its market performance hinges on several factors, including competitive landscape, patent protections, pricing strategies, and adoption rates.

Competitive Landscape

Position in HIV Treatment Market

SYMTUZA is positioned among integrase strand transfer inhibitors (INSTIs) and protease inhibitors (PIs). Its primary competitors include:

• Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide): Market leader with approximately 80% share in the HIV triple therapy sector in the U.S. as of 2022.
• Juluca (dolutegravir/rilpivirine) and Dovato (dolutegravir/lamivudine): Other fixed-dose combinations with significant market presence.
• Kelimune (darunavir/cobicistat/emtricitabine/tenofovir alafenamide): SYMTUZA's direct competitor, with similar composition but differentiated by manufacturer and pricing.

Market Penetration

Initially launched in 2020, SYMTUZA's market share is estimated at less than 5% of the total HIV ART market in the U.S. in 2022, due to competition from established brands and prescriber familiarity.

Patent and Exclusivity Timeline

Patent Protections

• Primary Patent Expiry: Expected in 2028, covering the composition of matter.
• Supplemental Patent Protections: Filed for formulation and method of use, extending patent life to 2030.
• Patent Challenges: Patent litigation by competitors could influence exclusivity duration. No significant threats reported as of Q4 2022.

Data Exclusivity

• Data exclusivity granted for five years, expiring in 2025, preventing generic entry until then.

Pricing Strategies and Reimbursement

Pricing

• The wholesale acquisition cost (WAC) for SYMTUZA is approximately $3,300 per month for a 30-day supply.
• Competitive with other fixed-dose combinations, but higher than generic PIs.

Reimbursement

• Coverage is universal under Medicare and Medicaid.
• Payers negotiate discounts; copay assistance programs alleviate patient cost burdens.

Revenue Projections and Growth Drivers

Current Revenue

• Estimated global sales in 2022 totaled $50 million, reflecting limited market penetration and generic competition pressures.

Growth Drivers

• Increased Prescriber Adoption: Education campaigns and clinical guidelines recommend SYMTUZA for certain patient populations.
• Expanding Markets: Entry into European and Asian markets could drive revenue growth.
• Line Extension and Combination Products: Potential future formulations or fixed-dose combinations may expand use cases.

Challenges

• Price competition from generics and biosimilars post-patent expiry.
• Market preference shifting toward integrase inhibitor-based regimens with higher tolerability profiles.
• Regulatory and reimbursement delays in non-U.S. markets.

Financial Outlook (2023-2027)

Year	Estimated Revenue (USD millions)	Key Growth Factors
2023	70	Expansion into new markets, improved prescriber uptake
2024	120	Launch of line extensions, increased generic competition
2025	180	Patent expiry, biosimilar entry, price competition
2026	150	Market consolidation, weight of generics
2027	130	Market saturation, competitive pressures

Strategic Considerations

• Patent Litigation: Monitoring patent challenges to defend exclusivity.
• Pricing and Access: Adjusting strategies to maintain competitiveness amid generics.
• Market Expansion: Targeting emerging markets with growing HIV incidence.
• Product Diversification: Developing new formulations or combinations to extend lifecycle.

Key Takeaways

• SYMTUZA remains a niche product with limited current revenue, primarily constrained by competition and patent protections expiring in 2028.
• The drug's market is subject to standard patent expiration risks and evolving treatment guidelines favoring newer agents.
• Revenue growth hinges on market expansion, prescriber adoption, and potential line extensions.
• Price competition from generics and biosimilars post-patent expiry will significantly impact profitability.
• Strategic investments in market penetration and product innovation are essential to sustain financial performance.

FAQs

1. What is the primary competitor of SYMTUZA?
   Kелимune, its direct generic competitor, and other fixed-dose combinations like Biktarvy.

2. When will SYMTUZA face generic competition?
   Patent protections expire around 2028, with legal challenges possibly influencing the timeline.

3. Can SYMTUZA be used outside the U.S.?
   Yes, but market availability depends on regulatory approval in individual countries.

4. What are the prospects for revenue growth?
   Moderate growth expected through market expansion and formulation line extensions before patent expiry impacts.

5. Will price reductions occur post-patent expiration?
   Likely, as generics and biosimilars enter the market, leading to decreased prices and revenue.

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References

[1] U.S. Food and Drug Administration. (2020). SYMTUZA approval letter.
[2] IQVIA. (2022). HIV Market Share Report.
[3] Sanford C. Bernstein. (2022). HIV/AIDS Market Outlook.