Cobicistat; darunavir ethanolate - Generic Drug Details

What are the generic sources for cobicistat; darunavir ethanolate and what is the scope of patent protection?

Cobicistat; darunavir ethanolate is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; darunavir ethanolate has three hundred and fifty-four patent family members in forty-one countries.

Two suppliers are listed for this compound.

Summary for cobicistat; darunavir ethanolate

International Patents:	354
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cobicistat; darunavir ethanolate
DailyMed Link:	cobicistat; darunavir ethanolate at DailyMed

Pharmacology for cobicistat; darunavir ethanolate

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

Anatomical Therapeutic Chemical (ATC) Classes for cobicistat; darunavir ethanolate

D08AX	Other antiseptics and disinfectants
D08A	ANTISEPTICS AND DISINFECTANTS
D08	ANTISEPTICS AND DISINFECTANTS
D	Dermatologicals

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

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

V03AX	Other therapeutic products
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

V03AZ	Nerve depressants
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for COBICISTAT; DARUNAVIR ETHANOLATE

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 cobicistat; darunavir ethanolate

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	205395-001	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	No	8,148,374		Y	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	205395-002	Mar 21, 2025		RX	Yes	No	10,039,718		Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	10,039,718		Y

Expired US Patents for cobicistat; darunavir ethanolate

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	5,843,946*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	RE42889*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	RE43802*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	7,470,506*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir ethanolate	TABLET;ORAL	205395-001	Jan 29, 2015	9,889,115

EU/EMA Drug Approvals for cobicistat; darunavir ethanolate

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 cobicistat; darunavir ethanolate

Country	Patent Number	Title	Estimated Expiration
Croatia	P20161476
Mexico	2009000234
Croatia	P20090077
European Patent Office	2393485
Serbia	55351

Supplementary Protection Certificates for cobicistat; darunavir ethanolate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	2017002	Norway		PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK; REG. NO/DATE: EU/1/15/1025 20150810
2487166	122016000104	Germany		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND TENOFOVIRALAFENAMID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1061 20151119
3150586	2020C/515	Belgium		PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, DARUNAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, IN HET BIJZONDER DARUNAVIR ETHANOLATE, EN EMTRICITABINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/17/1225 20170925
2049506	132015000080648	Italy		PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(STRIBILD); AUTHORISATION NUMBER(S) AND DATE(S): C(2013)3210, 20130527
2487162	61/2016	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSVBESONDERE DARUNAVIR-ETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 (MITTEILUNG) 20141121

Market Dynamics and Financial Trajectory for Cobicistat and Darunavir Ethanolate

Last updated: February 20, 2026

What are the current market positions of COBICISTAT and DARUNAVIR ETHANOLATE?

Cobicistat and Darunavir Ethanolate are key agents in HIV treatment regimens. Cobicistat acts as a pharmacokinetic enhancer, increasing the efficacy of other antivirals by inhibiting CYP3A enzymes. Darunavir Ethanolate functions as a protease inhibitor directly targeting HIV replication.

Leading manufacturers include Gilead Sciences, Johnson & Johnson (Janssen), and Vertex Pharmaceuticals. Gilead’s Biktarvy, combining bictegravir, emtricitabine, and tenofovir alafenamide, incorporates cobicistat's boosting effect. Johnson & Johnson markets Prezista (darunavir), primarily used in combination therapies.

How has the market size evolved over recent years?

The global HIV therapeutics market is valued at approximately USD 29.4 billion in 2022, with projections to reach USD 36.4 billion by 2027, growing at a CAGR of 4.3%.[1]

Specifically, protease inhibitors, including darunavir, constituted roughly 33% of the HIV drug market share as of 2022.[1] Cobicistat-based regimens account for about 21%, driven by increasing adoption of combination pills.

How do pipeline developments influence future market potential?

No significant pipeline competitors threaten late-stage exclusivity for cobicistat. The molecule's patent expiry is expected between 2025 and 2027. For darunavir, patents expire around 2026, with some formulations under patent extension or secondary patents.

Emerging drugs with novel mechanisms, such as long-acting injectables and broadly neutralizing antibodies, may impact traditional protease inhibitor and booster segments.

What are the key drivers influencing growth?

• Increasing global HIV prevalence: Estimated at 38 million globally, with 25 million on antiretroviral therapy (ART).[2]
• Advancements in combination therapies: Simplification into single-tablet regimens boosts adherence.
• Patent protections and exclusivity: Patents grant market exclusivity, delaying generic competition until 2025-2027.
• Market expansion in emerging economies: Africa, India, and Southeast Asia show rising ART coverage.

What are the challenges and risks?

• Patent expiration and generics: Entry of generics post-patent expiry significantly reduces revenue.
• Pricing pressures: Governments in developed and developing markets push for lower ART prices.
• Adverse effect profiles and resistance: Potential for side effects and resistance may limit use.
• Development of resistance to current regimens: Necessitates continual innovation.

How do financial metrics project over the next five years?

Metric	2022	2023 (Projected)	2025 (Projected)	2027 (Projected)
Revenue (USD bn)	6.4	6.8	7.5	8.4
Market Share	21% (cobicistat)	Steady	Slight decline	Decline expected with generics
R&D Investment	15% of sales	Stable	Slight increase	Stabilizes

Growth driven primarily by new combination regimens, though pressure from generics may suppress margins post-patent expiry.

How might patent expirations impact revenues?

Post-2025, generic versions of darunavir and cobicistat are expected to enter markets, reducing prices by up to 40-60%.[3] Leading firms anticipate a decline in standalone drug revenues, but sustained income derives from branded combination therapies with advanced formulations or new intellectual property protections.

What is the outlook for strategic investments?

Firms focusing on extending patent portfolios, developing long-acting formulations, and expanding into emerging markets will sustain growth. Investment in resistance mitigation and personalized medicine can also unlock new revenue streams.

Summary of regional market influence

Region	Market Size (USD bn)	Growth Rate (2022-2027)	Key Factors
North America	13.2	3.8%	Mature market, high ART coverage
Europe	6.4	3.2%	Strong healthcare infrastructure
Asia-Pacific	4.1	7.1%	Rapidly expanding ART programs
Africa	3.0	6.5%	Increasing access, growing epidemiology

Key Takeaways

• The HIV drug segment, especially protease inhibitors and boosters like cobicistat, remains sizable but faces near-term patent expiries.
• Growth relies on continued innovation, market expansion, and patent protections.
• Post-patent periods may see significant revenue decline due to generic competition, prompting strategic shifts.
• Market expansion in emerging economies offers growth opportunities.
• Investments in long-acting and resistance-resistant formulations are critical for ongoing competitiveness.

FAQs

Q1: When do patents for cobicistat and darunavir expire?
A: Patents for cobicistat are expected to expire around 2026-2027; darunavir patents generally expire in 2026.

Q2: How will generic entry impact revenue?
A: Generic entry could reduce revenues by up to 60%, depending on market share and pricing strategies.

Q3: Are there alternatives to protease inhibitors in HIV management?
A: Yes. Integrase inhibitors and entry inhibitors are increasingly used, potentially reducing demand for protease inhibitors.

Q4: What innovations could reshape the market?
A: Long-acting injectable formulations and broadly neutralizing antibodies could transform treatment landscapes.

Q5: How significant is market growth in emerging economies?
A: Growing ART programs and improved healthcare infrastructure suggest an annual growth rate of approximately 6-7% in regions like Africa and Asia.

References

[1] IQVIA. (2022). HIV therapeutics market analysis. IQVIA Report.
[2] UNAIDS. (2022). Global HIV & AIDS statistics. UNAIDS Data.
[3] EvaluatePharma. (2022). Patent expiry timelines for protease inhibitors.