COBICISTAT - Generic Drug Details

What are the generic drug sources for cobicistat and what is the scope of patent protection?

Cobicistat is the generic ingredient in six branded drugs marketed by Mylan Labs Ltd, Gilead Sciences Inc, and Janssen Prods, and is included in six NDAs. There are twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cobicistat has two hundred and ninety-five patent family members in forty countries.

There are five drug master file entries for cobicistat. One supplier is listed for this compound.

Summary for COBICISTAT

International Patents:	295
US Patents:	24
Tradenames:	6
Applicants:	3
NDAs:	6
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	129
Patent Applications:	1,313
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COBICISTAT
What excipients (inactive ingredients) are in COBICISTAT?	COBICISTAT excipients list
DailyMed Link:	COBICISTAT at DailyMed

Recent Clinical Trials for COBICISTAT

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

Sponsor	Phase
Insel Gruppe AG, University Hospital Bern	Phase 4
University of Bern	Phase 4
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland	Phase 4

See all COBICISTAT clinical trials

Pharmacology for COBICISTAT

Drug Class	Cytochrome P450 3A Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for COBICISTAT

Anti-HIV Agents

Cytochrome P-450 CYP3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for COBICISTAT

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

Paragraph IV (Patent) Challenges for COBICISTAT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TYBOST	Tablets	cobicistat	150 mg	203094	1	2016-11-14

US Patents and Regulatory Information for COBICISTAT

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
Gilead Sciences Inc	GENVOYA	cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	207561-001	Nov 5, 2015		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
Gilead Sciences Inc	TYBOST	cobicistat	TABLET;ORAL	203094-001	Sep 24, 2014	AB	RX	Yes	Yes
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		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

EU/EMA Drug Approvals for COBICISTAT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Tybost	cobicistat	EMEA/H/C/002572 Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.	Authorised	no	no	no	2013-09-19

International Patents for COBICISTAT

Country	Patent Number	Title	Estimated Expiration
Poland	2393485
Croatia	P20200349
Norway	2020011
Brazil	PI0714055	moduladores de propriedades farmacocinéticas de terapêuticos
Australia	2015200637	TABLETS FOR COMBINATION THERAPY
Spain	2553897

Supplementary Protection Certificates for COBICISTAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487163	300859	Netherlands		PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN ATAZANAVIR, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER ATAZANAVIRSULFAAT; REGISTRATION NO/DATE: EU/1/15/1025 20150715
2487162	132017000002735	Italy		PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO E DARUNAVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO(REZOLSTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/967, 20141121
2049506	C02049506/01	Switzerland		PRODUCT NAME: COBICISTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62673 18.10.2013
2487166	CA 2017 00004	Denmark		PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
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
2487163	381 2-2017	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/ATAZANAVIR VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1025 20150715

COBICISTAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Cobicistat in HIV-1 Treatment

Introduction to Cobicistat

Cobicistat, marketed under the name Tybost, is a crucial component in the treatment of HIV-1 infection. It acts as a pharmacokinetic enhancer by inhibiting the CYP3A isoforms, thereby increasing the systemic exposure of coadministered antiretroviral agents without the need for increased dosages[4].

Role in HIV-1 Treatment

Cobicistat is used in combination with other antiretroviral agents to treat HIV-1 infection. It is particularly effective when combined with atazanavir or darunavir, enhancing their systemic exposure and improving treatment outcomes. This combination allows for better viral suppression and a reduced side effect profile[4].

Market Presence and Formulations

Cobicistat is part of several single-tablet regimens (STRs) and combination therapies, including Genvoya, Stribild, Prezcobix, Rezolsta, and Evotaz. These formulations have significantly impacted the HIV-1 treatment market by offering patients more convenient and effective treatment options[1][3][4].

Market Trends and Preferences

The HIV-1 treatment market is shifting towards single-tablet regimens (STRs) over multiple tablet regimens (MTRs). This trend is driven by patient and physician preferences for simpler, more convenient treatment options. Cobicistat, as a component of STRs like Genvoya and Stribild, has benefited from this shift. For instance, the US market for STRs increased from $10,305 million in 2018 to $13,620 million in 2020, while the market for MTRs declined from $5,918 million to $3,867 million during the same period[1].

Financial Performance

Cobicistat-containing drugs have shown strong financial performance. For example, Genvoya, which includes cobicistat, generated $302 million in worldwide sales within its first six months of launch in 2015. By the second quarter, sales nearly doubled, contributing significantly to Gilead Sciences' HIV revenue, which reached $3.1 billion for the period[3].

Impact of Biktarvy on the Market

The launch of Biktarvy, another highly effective STR, has influenced the market dynamics of cobicistat-containing drugs. Biktarvy, which does not require pharmacokinetic boosting, has captured a significant market share, leading to a decline in sales of older TDF-based and TAF-based regimens, including those containing cobicistat. Despite this, cobicistat remains a vital component in many treatment regimens due to its efficacy and convenience[1].

Patent Landscape and Generic Challenges

The patent landscape for cobicistat-containing drugs is complex, with multiple patents protecting these products. For instance, Genvoya has several patents that are set to expire in the coming years, which could lead to the introduction of generic versions. However, the strong interest in these patents, as evidenced by numerous patent litigation cases, suggests that the market will remain competitive even after patent expirations[3][4].

Economic Evaluation

Studies have shown that cobicistat-boosted regimens, such as darunavir/cobicistat, can offer economic benefits. For example, darunavir/cobicistat has been shown to result in annual savings per patient equivalent to the annual cost of treatment with ritonavir, highlighting the cost-effectiveness of these regimens[5].

Future Outlook

The HIV-1 treatment market is expected to show steady growth, although it may be affected by patent expiries and the emergence of new therapies. Cobicistat-containing drugs will need to compete with newer treatments, such as long-acting therapies like Cabenuva, which are gaining traction. However, the established efficacy and convenience of cobicistat-based regimens ensure they will remain significant players in the market[1].

Key Takeaways

• Market Shift: The HIV-1 treatment market is favoring single-tablet regimens over multiple tablet regimens.
• Financial Performance: Cobicistat-containing drugs have shown strong financial performance, particularly Genvoya.
• Competition: The launch of Biktarvy has impacted the sales of older regimens, including those containing cobicistat.
• Patent Landscape: Multiple patents protect cobicistat-containing drugs, with several set to expire in the coming years.
• Economic Benefits: Cobicistat-boosted regimens offer economic savings compared to other treatments.

FAQs

What is the primary role of cobicistat in HIV-1 treatment?

Cobicistat acts as a pharmacokinetic enhancer by inhibiting CYP3A isoforms, increasing the systemic exposure of coadministered antiretroviral agents without the need for increased dosages.

Which drugs include cobicistat as a component?

Cobicistat is part of several drugs, including Genvoya, Stribild, Prezcobix, Rezolsta, and Evotaz.

How has the market trend affected cobicistat-containing drugs?

The shift towards single-tablet regimens has benefited cobicistat-containing drugs, but the emergence of new treatments like Biktarvy has led to a decline in sales of some older regimens.

What are the economic benefits of cobicistat-boosted regimens?

Cobicistat-boosted regimens, such as darunavir/cobicistat, offer annual savings per patient equivalent to the annual cost of treatment with ritonavir.

What is the future outlook for cobicistat in the HIV-1 treatment market?

Cobicistat-containing drugs will continue to be significant players, but they will face competition from newer treatments and be affected by patent expiries.

Sources

1. DelveInsight: Changing Dynamics of HIV-1 Treatment Market.
2. Oxford Academic: Trial of a Single-tablet Regimen of Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Disoproxil Fumarate.
3. DrugPatentWatch: When will the GENVOYA patents expire, and when will generic versions be available?
4. DrugBank: Cobicistat: Uses, Interactions, Mechanism of Action.
5. Value in Health: Economic Evaluation Of Cobicistat-Boosted Darunavir In HIV.