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Last Updated: December 25, 2024

Cobicistat - Generic Drug Details


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What are the generic 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
Recent Clinical Trials for cobicistat

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

SponsorPhase
Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandPhase 4
Insel Gruppe AG, University Hospital BernPhase 4
University of BernPhase 4

See all cobicistat clinical trials

Medical Subject Heading (MeSH) Categories for cobicistat
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
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for cobicistat

Country Patent Number Title Estimated Expiration
Lithuania C2487163 ⤷  Subscribe
Eurasian Patent Organization 021313 ТАБЛЕТКИ ДЛЯ КОМБИНИРОВАННОЙ ТЕРАПИИ (TABLETS FOR COMBINATION THERAPY) ⤷  Subscribe
Spain 2796275 ⤷  Subscribe
Serbia 55280 MODULATORI FARMAKOKINETIČKIH SVOJSTAVA LEKOVA (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS) ⤷  Subscribe
Ukraine 101193 ПРИМЕНЕНИЕ ЧАСТИЧЕК ТВЕРДОГО НОСИТЕЛЯ ДЛЯ УЛУЧШЕНИЯ ТЕХНОЛОГИЧЕСКИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧЕСКОГО АГЕНТА;ЗАСТОСУВАННЯ ЧАСТИНОК ТВЕРДОГО НОСІЯ ДЛЯ ПОЛІПШЕННЯ ТЕХНОЛОГІЧНИХ ХАРАКТЕРИСТИК ФАРМАЦЕВТИЧНОГО АГЕНТА (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cobicistat

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487166 2016/061 Ireland ⤷  Subscribe PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2487166 93354 Luxembourg ⤷  Subscribe PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI ET ALAFENAMIDE DE TENOFOVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE D'ALAFENAMIDE DE TENOFOVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1061
2487166 300860 Netherlands ⤷  Subscribe PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN TENOFOVIR-ALAFENAMIDE, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIR-ALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1061 20151123
2487163 17C1000 France ⤷  Subscribe PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET ATAZANAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER LE SULFATE D'ATAZANAVIR; REGISTRATION NO/DATE: EU/1/15/1025 20150715
2487163 1790002-8 Sweden ⤷  Subscribe PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/15/1025, 2015-07-15
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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.

More… ↓

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