SUSTIVA Drug Patent Profile

When do Sustiva patents expire, and when can generic versions of Sustiva launch?

Sustiva is a drug marketed by Bristol Myers Squibb and is included in two NDAs.

The generic ingredient in SUSTIVA is efavirenz. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the efavirenz profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sustiva

A generic version of SUSTIVA was approved as efavirenz by AUROBINDO PHARMA on December 15^th, 2017.

Summary for SUSTIVA

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	68
Patent Applications:	5,716
Drug Prices:	Drug price information for SUSTIVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUSTIVA
What excipients (inactive ingredients) are in SUSTIVA?	SUSTIVA excipients list
DailyMed Link:	SUSTIVA at DailyMed

See drug prices for SUSTIVA

Recent Clinical Trials for SUSTIVA

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

Sponsor	Phase
Massachusetts General Hospital	Phase 1
Case Western Reserve University	Phase 1
University Hospitals Cleveland Medical Center	Phase 1

See all SUSTIVA clinical trials

Paragraph IV (Patent) Challenges for SUSTIVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUSTIVA	Capsules	efavirenz	50 mg, 100 mg and 200 mg	020972	1	2016-11-03
SUSTIVA	Tablets	efavirenz	600 mg	021360	1	2009-04-09

US Patents and Regulatory Information for SUSTIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-001	Sep 17, 1998		DISCN	Yes	No
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002		DISCN	Yes	No
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-002	Sep 17, 1998		DISCN	Yes	No
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-003	Sep 17, 1998		DISCN	Yes	No

Expired US Patents for SUSTIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002	5,663,169*PED
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-002	Sep 17, 1998	5,811,423
Bristol Myers Squibb	SUSTIVA	efavirenz	CAPSULE;ORAL	020972-003	Sep 17, 1998	5,811,423
Bristol Myers Squibb	SUSTIVA	efavirenz	TABLET;ORAL	021360-001	Feb 1, 2002	5,519,021*PED

EU/EMA Drug Approvals for SUSTIVA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Efavirenz Teva	efavirenz	EMEA/H/C/002352 Efavirenz is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children 3 years of age and older.Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with protease inhibitors (PIs) has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing efavirenz.	Authorised	yes	no	no	2012-01-09
Merck Sharp & Dohme B.V.	Stocrin	efavirenz	EMEA/H/C/000250 Stocrin is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older.Stocrin has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Stocrin.	Authorised	no	no	no	1999-05-28
Bristol-Myers Squibb Pharma EEIG	Sustiva	efavirenz	EMEA/H/C/000249 Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older.Sustiva has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Sustiva.	Authorised	no	no	no	1999-05-28

International Patents for SUSTIVA

See the table below for patents covering SUSTIVA around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	197740
Denmark	0582455
Germany	69902893
China	1191242

Supplementary Protection Certificates for SUSTIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0582455	2008/016	Ireland		PRODUCT NAME: A COMBINATION OF EFAVIRENZ AND EMTRICTABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0915894	C00915894/02	Switzerland		PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
0915894	SPC/GB08/033	United Kingdom		PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED
0582455	CA 2008 00026	Denmark

SUSTIVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SUSTIVA (Efavirenz)

Overview of SUSTIVA

SUSTIVA, known generically as efavirenz, is an antiretroviral drug used in the treatment of HIV-1 infection. It belongs to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs) and is often used in combination with other antiretroviral medications.

Mechanism of Action and Pharmacology

Efavirenz works by inhibiting the reverse transcriptase enzyme, which is essential for the replication of HIV. This mechanism helps in reducing the viral load in the body, thereby slowing down the progression of the disease[2].

Market Assessment

Historical Sales

The global market for SUSTIVA has seen significant activity over the years. Historical sales data indicate that the drug has been a key player in the HIV treatment market. The "SUSTIVA - Drug Insight, 2019" report by ResearchAndMarkets.com provides detailed historical sales figures and forecasts for the period 2019-2021[1].

Forecasted Sales

Despite the impact of the COVID-19 pandemic on the pharmaceutical industry, the HIV drugs market, including SUSTIVA, is expected to recover and grow. The global HIV drugs market is projected to increase from $36.11 billion in 2024 to $58.24 billion by 2032, with a CAGR of 6.2%[4].

Market Competition

The HIV drugs market is highly competitive, with several key players such as ViiV Healthcare, Gilead Sciences, Janssen Pharmaceuticals, and Merck. SUSTIVA, being a well-established drug, faces competition from both branded and generic versions. The entry of generic competitors can significantly impact the market share and pricing of SUSTIVA, as generic drug prices tend to fall with the number of competitors, approaching long-run marginal costs when there are 8 or more competitors[3].

Patent Details and Market Exclusivity

SUSTIVA's patent details and market exclusivity play a crucial role in its market dynamics. The original patents for efavirenz have expired, allowing generic versions to enter the market. This has led to increased competition and a potential decrease in the market share of the branded version of SUSTIVA[1].

Global API Manufacturers Assessment

The production of SUSTIVA involves several Active Pharmaceutical Ingredient (API) manufacturers across different regions. The report by ResearchAndMarkets.com highlights the global API manufacturers by country and region, which is essential for understanding the supply chain and potential disruptions[1].

Adverse Reactions and Safety Profile

SUSTIVA is associated with several adverse reactions, including central nervous system symptoms such as dizziness, insomnia, and hallucinations. Serious psychiatric events, including severe depression, suicidal ideation, and aggressive behavior, have also been reported. These adverse reactions can impact patient compliance and overall market demand[2].

Regulatory Milestones

SUSTIVA has undergone various regulatory milestones, including approvals and updates to its labeling. Regulatory changes can influence the drug's market trajectory by affecting its safety profile, dosing recommendations, and contraindications[2].

Deals and Partnerships

The HIV treatment landscape is dynamic, with frequent collaborations and partnerships among pharmaceutical companies. For instance, Gilead Sciences Inc. and Merck Sharp & Dohme have entered into agreements for the co-development and co-commercialization of new HIV treatments, which can impact the market share of existing drugs like SUSTIVA[4].

Emerging Therapies

The development of new and emerging therapies, such as long-acting suppression antiretroviral therapies, is a significant trend in the HIV drugs market. These new treatments can potentially replace or complement existing drugs like SUSTIVA, affecting its market position[4].

SWOT Analysis

Strengths

• Established brand with a long history of use.
• Wide distribution and availability.
• Part of combination therapies that are highly effective.

Weaknesses

• Associated with significant adverse reactions.
• Patent expiration leading to generic competition.
• High cost compared to some generic alternatives.

Opportunities

• Growing demand for HIV treatments globally.
• Potential for use in new combination therapies.
• Increasing awareness and government initiatives.

Threats

• Competition from new and emerging therapies.
• Economic factors and pricing pressures.
• Regulatory changes affecting safety profiles and labeling.

Financial Trajectory

Revenue Impact

The revenue from SUSTIVA has been impacted by the COVID-19 pandemic, with many pharmaceutical companies reporting decreased sales due to lower prescription volumes and supply chain disruptions. However, with the recovery of the market, SUSTIVA is expected to contribute to the overall growth of the HIV drugs market[4].

Market Share

The market share of SUSTIVA is likely to be affected by the increasing competition from generic versions and new therapies. Despite this, it remains a significant player in the HIV treatment market due to its established brand and efficacy[1].

Regional Performance

North America, particularly the U.S., is a dominant market for SUSTIVA due to the high prevalence of HIV infection and strong healthcare infrastructure. The drug's performance in this region is crucial for its overall financial trajectory[4].

Key Takeaways

• SUSTIVA is a well-established antiretroviral drug with a significant market presence.
• The drug faces competition from generic versions and new therapies.
• Adverse reactions and regulatory changes can impact its market demand.
• The global HIV drugs market is expected to grow, driven by increasing patient populations and new product launches.
• SUSTIVA's financial trajectory will be influenced by its ability to adapt to market changes and maintain its market share.

FAQs

Q: What is SUSTIVA used for?

A: SUSTIVA (efavirenz) is used in the treatment of HIV-1 infection, often in combination with other antiretroviral medications.

Q: What are the common adverse reactions associated with SUSTIVA?

A: Common adverse reactions include central nervous system symptoms such as dizziness, insomnia, and hallucinations, as well as serious psychiatric events like severe depression and suicidal ideation.

Q: How has the COVID-19 pandemic affected the sales of SUSTIVA?

A: The pandemic has adversely impacted the sales of SUSTIVA due to disruptions in the supply chain and lower prescription volumes, but the market is expected to recover.

Q: What is the forecasted growth of the global HIV drugs market?

A: The global HIV drugs market is expected to grow from $36.11 billion in 2024 to $58.24 billion by 2032, with a CAGR of 6.2%.

Q: Who are the key players in the global HIV drugs market?

A: Key players include ViiV Healthcare, Gilead Sciences, Janssen Pharmaceuticals, and Merck.

Sources:

1. ResearchAndMarkets.com - "Sustiva - Drug Insight, 2019"
2. FDA - "SUSTIVA (efavirenz) Label"
3. Federal Trade Commission - "Generic Drug Industry Dynamics"
4. Fortune Business Insights - "HIV Drugs Market Size & Growth | Global Report [2024-2032]"