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SYMTUZA Drug Patent Profile

Which patents cover Symtuza, and what generic alternatives are available?

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

This drug has four hundred and eighty-five patent family members in fifty-one 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 October 6, 2032. This may change due to patent challenges or generic licensing.

There have been thirty 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:	485
US Patents:	8
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:

10,039,718

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 fifteen US patents.

This potential generic entry date is based on patent 10,039,718.

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	7,390,791		Y	Y
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

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	9,889,115
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	8,597,876
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	7,803,788

International Patents for SYMTUZA

When does loss-of-exclusivity occur for SYMTUZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Peru

Poland

Portugal

San Marino

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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

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

Country	Patent Number	Title	Estimated Expiration
Canada	2692331	MODULATEURS DES PROPRIETES PHARMACOCINETIQUES DE SUBSTANCES THERAPEUTIQUES (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS)
South Korea	20150042869	치료제의 약동학 특성의 모듈레이터 (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS)
Singapore	10201705929Q	MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS
Taiwan	201268
South Korea	20100040896	MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS

Supplementary Protection Certificates for SYMTUZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	SPC/GB17/010	United Kingdom		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REGISTERED: UK EU/1/15/1025/001 20150715; UK EU/1/15/1025/002 20150715
2487162	2016C/068	Belgium		PRODUCT NAME: COBICISTAT ET DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967 20141121
0513200	C00513200/01	Switzerland		PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
1301519	300803	Netherlands		PRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123
2487166	2016C/065	Belgium		PRODUCT NAME: COBICISTAT AND TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/15/1061 20151123

SYMTUZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Symtuza

Introduction

Symtuza, a once-daily HIV medication developed by Johnson & Johnson's Janssen Pharmaceuticals, was approved by the FDA in 2018. This drug represents a significant addition to the treatment options for HIV, but it faces a highly competitive market. Here, we will delve into the market dynamics and the financial trajectory of Symtuza.

Market Approval and Indications

Symtuza is a combination of darunavir, a protease inhibitor, with cobicistat, emtricitabine, and tenofovir alafenamide. It is the first and only complete, darunavir-based single-tablet regimen for the treatment of HIV-1 in treatment-naive and certain virologically suppressed adults[1][4].

Competitive Landscape

The HIV treatment market is crowded and competitive, with several established players. At the time of Symtuza's approval, it had to contend with other recently approved drugs such as Gilead Sciences' Biktarvy and Juluca, developed by J&J and GlaxoSmithKline.

• Biktarvy: This drug, approved early in 2018, combines the novel integrase inhibitor bictegravir with emtricitabine and tenofovir alafenamide. Biktarvy has been highly successful, with projected peak sales of $6 billion to $10 billion[1].
• Juluca: Another competitor, Juluca is the first two-drug regimen for HIV, consisting of dolutegravir and rilpivirine. It offers a simpler treatment option, which can be a significant advantage in terms of adherence[1].

Clinical Trials and Efficacy

Symtuza's approval was based on two Phase 3 trials. The first trial showed that Symtuza was non-inferior to a combination of J&J's Prezista plus Gilead's Truvada in treatment-naive patients. The second trial found little difference in virologic failure or suppression rates between patients who stayed on Truvada plus a boosted protease inhibitor and those who switched to Symtuza[4].

Differentiation and Market Position

Given the competitive landscape, differentiating Symtuza is crucial. Here are a few key points:

• Convenience: Symtuza offers the convenience of a single-tablet regimen, which can improve adherence.
• Tolerability: The formulation is designed for improved tolerability, which can be a significant factor in patient compliance[1].
• Black Box Warning: Symtuza carries a black box warning for post-treatment acute exacerbation of hepatitis B, a common caution with many HIV drugs[1][4].

Financial Performance

While Symtuza is an important addition to J&J's portfolio, its financial impact is relatively modest compared to other products.

• Revenue Contribution: Symtuza does not contribute significantly to J&J's overall pharmaceutical revenue. For example, Edurant (rilpivirine), another HIV drug from J&J, generated $211 million in the second quarter of 2018, which is about 2% of J&J's pharmaceutical revenue[4].
• Market Sales: The exact sales figures for Symtuza are not publicly disclosed in detail, but it is clear that it faces stiff competition from drugs like Biktarvy, which has seen substantial sales growth. Biktarvy's sales were projected at $1 billion in its first year and are expected to peak at $6 billion to $10 billion[1].

Impact on J&J's Financials

J&J's overall financial performance is diverse and not heavily reliant on HIV drugs.

• Q4 and Full-Year Results: In 2023, J&J reported a 7.3% increase in fourth-quarter sales and a 10.6% increase in full-year sales, driven by various segments including Innovative Medicine and MedTech. However, the specific contribution of Symtuza to these figures is not highlighted[2].

Market Trends and Future Outlook

The HIV treatment market continues to evolve with new drugs and treatment regimens.

• Patient Uptake: The continued patient uptake of newer drugs like Biktarvy and Descovy has been a trend. Symtuza needs to capture a significant share of this market to be financially viable[3].
• Competition and Innovation: The market is driven by innovation, with companies continuously developing new and improved treatments. Symtuza's success will depend on its ability to differentiate itself and adapt to these market dynamics.

Key Takeaways

• Competitive Market: Symtuza enters a crowded market with established competitors like Biktarvy and Juluca.
• Differentiation: Its single-tablet regimen and improved tolerability are key differentiators.
• Financial Impact: Symtuza's financial contribution to J&J is relatively modest.
• Market Trends: The market is driven by patient uptake of newer, more convenient treatments.

FAQs

Q: What is Symtuza, and how is it used? A: Symtuza is a once-daily HIV medication that combines darunavir, cobicistat, emtricitabine, and tenofovir alafenamide. It is used for the treatment of HIV-1 in treatment-naive and certain virologically suppressed adults.

Q: What are the main competitors of Symtuza in the HIV treatment market? A: The main competitors include Gilead Sciences' Biktarvy and Juluca, developed by J&J and GlaxoSmithKline.

Q: What are the key differentiators of Symtuza? A: Symtuza offers the convenience of a single-tablet regimen and is designed for improved tolerability.

Q: Does Symtuza carry any significant warnings? A: Yes, Symtuza carries a black box warning for post-treatment acute exacerbation of hepatitis B.

Q: How significant is Symtuza's contribution to J&J's overall revenue? A: Symtuza's contribution to J&J's revenue is relatively modest compared to other pharmaceutical products.

Sources

1. FiercePharma: Janssen wins FDA nod for Symtuza but the once-daily HIV drug ...
2. Johnson & Johnson Investor Relations: Johnson & Johnson Reports Q4 and Full-Year 2023 Results
3. Gilead Sciences News: Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results
4. BioPharma Dive: Where does J&J's new drug fit in the crowded HIV market?