Cobicistat; darunavir - Generic Drug Details

What are the generic sources for cobicistat; darunavir and what is the scope of freedom to operate?

Cobicistat; darunavir is the generic ingredient in two branded drugs marketed by Janssen Prods and is included in two NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; darunavir has three hundred and forty-three patent family members in forty countries.

Two suppliers are listed for this compound.

Summary for cobicistat; darunavir

International Patents:	343
US Patents:	10
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	55
DailyMed Link:	cobicistat; darunavir at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cobicistat; darunavir

Constraining patent/regulatory exclusivity:

10,039,718

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 cobicistat; darunavir

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

Sponsor	Phase
East Carolina University	Phase 4
Azienda Ospedaliero-Universitaria di Parma	Phase 2
University of Parma	Phase 2

See all cobicistat; darunavir clinical trials

Pharmacology for cobicistat; darunavir

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

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

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

Paragraph IV (Patent) Challenges for COBICISTAT; DARUNAVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PREZCOBIX	Tablets	cobicistat; darunavir	800 mg/150 mg	205395	1	2020-07-24

US Patents and Regulatory Information for cobicistat; darunavir

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	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	8,518,987*PED				Y
Janssen Prods	SYMTUZA	cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	210455-001	Jul 17, 2018		RX	Yes	Yes	8,518,987		Y	Y
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015		RX	Yes	Yes	7,700,645*PED				Y

Expired US Patents for cobicistat; darunavir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015	9,889,115
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015	5,843,946*PED
Janssen Prods	PREZCOBIX	cobicistat; darunavir	TABLET;ORAL	205395-001	Jan 29, 2015	RE43596*PED

EU/EMA Drug Approvals for cobicistat; darunavir

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/002819 Rezolsta, 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

Country	Patent Number	Title	Estimated Expiration
Taiwan	I496778
Lithuania	C2487163
Cyprus	2017003

Supplementary Protection Certificates for cobicistat; darunavir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049506	262 5024-2015	Slovakia		PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM; REGISTRATION NO/DATE: EU/1/13/830 20130527
2487162	PA2016040,C2487162	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS IR DARUNAVIRAS,ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS; REGISTRATION NO/DATE: EU/1/14/967 20141119
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

Cobicistat; darunavir Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cobicistat and Darunavir

Introduction to Cobicistat and Darunavir

Cobicistat and darunavir are key components in the treatment of HIV-1 infection. Darunavir, a protease inhibitor, is often boosted with cobicistat, a CYP3A4 inhibitor, to enhance its efficacy. This combination is available in various fixed-dose formulations, such as Prezista, Rezolsta, and Symtuza[3][4].

Market Scope and Geographic Distribution

The market for cobicistat and darunavir spans across several major countries, including the US, Germany, France, Italy, Spain, UK, Japan, Brazil, Russia, India, China, Canada, and Australia. This broad geographic distribution is crucial for understanding the global demand and sales trends of these medications[1].

Sales Analysis

The sales data for cobicistat and darunavir indicate significant market presence and growth. Reports from ResearchAndMarkets.com provide detailed sales and price analyses, highlighting the growth trends by country. For instance, the sales forecasts until 2021 showed a steady increase in demand, driven by the efficacy and convenience of the fixed-dose combination tablets[1].

Price Analysis by Countries

The price of cobicistat and darunavir varies significantly across different countries. The unit price analysis reveals that pricing strategies differ based on regional market conditions, regulatory environments, and competition. This variability is essential for pharmaceutical companies to adjust their pricing and marketing strategies accordingly[1].

Sales Forecast

Sales forecasts for cobicistat and darunavir are optimistic, reflecting the ongoing need for effective HIV-1 treatments. The forecasts indicate continued growth, driven by the increasing prevalence of HIV and the preference for once-daily, fixed-dose combination regimens that simplify treatment adherence[1].

Impact of Regulatory Updates

Regulatory updates, such as those related to the use of darunavir boosted with cobicistat during pregnancy, can significantly impact market dynamics. For example, the advice against initiating darunavir/cobicistat therapy during pregnancy due to lower darunavir exposure and associated risks may influence prescribing patterns and overall sales[2].

Pharmacoeconomic Considerations

The pharmacoeconomic review of darunavir/cobicistat highlights its cost-effectiveness in the treatment of HIV-1. The combination is often compared to other antiretroviral regimens, and its once-daily dosing and reduced pill burden contribute to its economic viability and patient compliance[3].

Clinical Efficacy and Safety

The clinical efficacy of darunavir boosted with cobicistat is well-documented. Studies have shown that this combination is as effective as darunavir boosted with ritonavir, with similar adverse reaction profiles. This equivalence in efficacy and safety supports its widespread adoption in HIV treatment regimens[4].

Market Competition

The HIV treatment market is highly competitive, with several antiretroviral therapies available. However, the convenience and efficacy of the darunavir/cobicistat combination position it favorably against other treatments. The fixed-dose formulations, such as Rezolsta and Symtuza, offer a competitive edge by reducing the number of pills patients need to take daily[4].

Patient and Prescriber Preferences

Patient and prescriber preferences play a crucial role in the market dynamics of cobicistat and darunavir. The once-daily dosing and reduced pill burden are significant factors in patient adherence and satisfaction. Prescribers also favor this combination due to its proven efficacy and safety profile[4].

Financial Performance

The financial performance of cobicistat and darunavir is robust, driven by strong sales and a stable market position. The approval of PrezcoBIX in the US and other regions has contributed significantly to the revenue generated by these medications. The sales revenues worldwide and by country provide a clear picture of the financial trajectory, which is generally upward due to the ongoing demand for effective HIV treatments[1][4].

Future Outlook

The future outlook for cobicistat and darunavir remains positive. Continued research and development in the field of HIV treatment, along with the potential for expanded indications, are expected to sustain market growth. However, the market will also be influenced by the emergence of new antiretroviral therapies and changes in regulatory guidelines.

Key Takeaways

• Global Market Presence: Cobicistat and darunavir have a significant presence in major markets worldwide.
• Sales and Price Trends: Sales are forecasted to grow, with varying prices across different countries.
• Regulatory Considerations: Updates on use during pregnancy can impact sales and prescribing patterns.
• Clinical Efficacy: The combination is as effective as darunavir boosted with ritonavir.
• Market Competition: The convenience of fixed-dose formulations gives it a competitive edge.
• Patient and Prescriber Preferences: Once-daily dosing and reduced pill burden are key factors.
• Financial Performance: Strong sales and a stable market position contribute to robust financial performance.

FAQs

Q: What is the primary indication for the use of cobicistat and darunavir? A: Cobicistat and darunavir are used in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naive and treatment-experienced adults without darunavir resistance-associated mutations[3][4].

Q: Why is darunavir often boosted with cobicistat? A: Cobicistat is used as a booster to increase the levels of darunavir in the body, enhancing its efficacy against HIV-1[3][4].

Q: What are the potential risks associated with using darunavir/cobicistat during pregnancy? A: Low darunavir exposure during pregnancy may be associated with an increased risk of treatment failure and maternal-to-child transmission of HIV-1[2].

Q: How do the sales forecasts for cobicistat and darunavir look? A: Sales forecasts indicate continued growth, driven by the increasing prevalence of HIV and the preference for once-daily, fixed-dose combination regimens[1].

Q: What are the most common adverse reactions associated with darunavir/cobicistat? A: The most common adverse reactions include diarrhea, nausea, rash, headache, abdominal pain, and vomiting[4].

Sources

1. ResearchAndMarkets.com: Cobicistat / Darunavir Sales, Price Analysis, & Sales Forecast 2017.
2. GOV.UK: Darunavir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1.
3. NCBI: Pharmacoeconomic Review Report - Darunavir/Cobicistat (Prezcobix).
4. JNJ.com: PREZCOBIX™ (darunavir/cobicistat) Approved in the U.S. for the Treatment of Adults Living with HIV-1.