RETROVIR Drug Patent Profile

Which patents cover Retrovir, and what generic alternatives are available?

Retrovir is a drug marketed by Viiv Hlthcare and is included in four NDAs.

The generic ingredient in RETROVIR is zidovudine. There are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the zidovudine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Retrovir

A generic version of RETROVIR was approved as zidovudine by AUROBINDO on September 19^th, 2005.

Summary for RETROVIR

US Patents:	0
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	49
Drug Prices:	Drug price information for RETROVIR
What excipients (inactive ingredients) are in RETROVIR?	RETROVIR excipients list
DailyMed Link:	RETROVIR at DailyMed

See drug prices for RETROVIR

Recent Clinical Trials for RETROVIR

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

Sponsor	Phase
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 4
International Maternal Pediatric Adolescent AIDS Clinical Trials Group	Phase 4

See all RETROVIR clinical trials

Pharmacology for RETROVIR

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

US Patents and Regulatory Information for RETROVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987	AB	RX	Yes	Yes
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995		DISCN	No	No
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990		RX	Yes	Yes
Viiv Hlthcare	RETROVIR	zidovudine	SOLUTION;ORAL	019910-001	Sep 28, 1989	AA	RX	Yes	Yes
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-002	Oct 4, 1996		DISCN	Yes	No

Expired US Patents for RETROVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987
Viiv Hlthcare	RETROVIR	zidovudine	SOLUTION;ORAL	019910-001	Sep 28, 1989

International Patents for RETROVIR

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

Country	Patent Number	Title	Estimated Expiration
Spain	2006672	PROCEDIMIENTO PARA PREPARAR FORMULACIONES FARMACEUTICAS A BASE DE 3'-AZIDO-NUCLEOSIDOS. (New and known 3-azido-nucleoside(s) - useful for therapy of viral and bacterial infections esp. HIV retro-viral infections and resistant gram negative bacterial infections)
Japan	S63290895	ANTIVIRAL NUCLEOSIDE
Hungary	199501	PROCESS FOR PRODUCING 3'-AZIDO-3'-DEOXYTIMIDINE-5' ESTER DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME
Austria	44464
Denmark	164392

Supplementary Protection Certificates for RETROVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0513917	C980018	Netherlands		PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
0513917	98C0020	Belgium		PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
0513917	SPC/GB98/019	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND ZIDOVUDINE; REGISTERED: UK EU/1/98/058/001 19980318; UK EU/1/98/058/002 19980318

RETROVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Antiretroviral Drugs: A Focus on RETROVIR

Introduction

Antiretroviral drugs, including RETROVIR (zidovudine), are crucial in the management and treatment of HIV/AIDS. The market for these drugs is complex, influenced by various factors such as prevalence of HIV, advancements in drug development, and economic considerations.

Global Market Size and Growth

The global anti-retroviral drugs market was valued at USD 29.1 billion in 2023 and is anticipated to grow at a CAGR of 4.2% from 2024 to 2032, reaching USD 42.5 billion by 2032[1].

Key Drivers of Market Growth

Rising HIV Prevalence

The increasing number of people living with HIV is a significant driver of the market. As of 2021, approximately 38.4 million individuals globally were living with HIV, with the African region being the most severely affected[1][4].

Advancements in Drug Development

Continuous research and development have led to the introduction of novel and more effective antiretroviral drugs. This includes the development of combination therapies and long-acting formulations, which enhance patient outcomes and drive market growth[1][3].

Increased Accessibility and Awareness

Improved access to HIV testing and intensified awareness campaigns have facilitated early diagnosis and treatment initiation, contributing to the demand for antiretroviral drugs[3].

Market Segmentation

By Product

The market is segmented into various drug classes, including protease inhibitors, integrase inhibitors, multi-class combination products, nucleoside reverse transcriptase inhibitors (NRTIs), and non-nucleoside reverse transcriptase inhibitors (NNRTIs). Multi-class combination products dominated the market in 2023 with revenue of USD 7.9 billion[1].

By Type

The market is divided into branded and generic segments. Branded drugs held the highest business share of 67.2% in 2023, although generic alternatives are increasingly gaining traction due to their cost-effectiveness[1].

By Age Group

The adult segment is expected to hold the highest revenue throughout the forecast period, given the higher prevalence of HIV among adults[1].

By Distribution Channel

Hospital pharmacies held the highest business share of 43.1% in 2023, followed by retail and online pharmacies[1].

Regional Dynamics

North America

North America is expected to dominate the market throughout the forecast period due to the presence of key market players, technological advancements, and a high number of HIV cases. The region has seen significant outbreaks, such as the one in Tijuana, Mexico, which has driven the demand for antiretroviral drugs[1][4].

Financial Considerations

Cost of Antiretroviral Therapy

The cost of antiretroviral therapy (ART) is substantial. A study estimated that the discounted lifetime medical costs for an individual acquiring HIV at 35 years of age are $326,500, with 60% of these costs attributable to ART[2].

Cost Savings with Generic Drugs

The use of generic antiretroviral drugs can significantly reduce costs. For instance, switching from branded to generic regimens can save millions of dollars over a few years. In the U.S., the transition to generic ART could help cover the projected costs to reach national treatment targets[2].

Impact of Patent Expiration

The expiration of patents for major HIV treatments leads to the availability of generic substitutes, which can lower the market share and financial success of branded drugs. This shift towards generics is expected to continue, influencing the financial trajectory of the market[3].

RETROVIR (Zidovudine) in the Market

Historical Significance

RETROVIR, or zidovudine, was one of the first antiretroviral drugs approved for the treatment of HIV/AIDS. It belongs to the NRTI class and has been a cornerstone in HIV treatment since its introduction.

Current Market Position

While RETROVIR remains an important drug, its market share has been impacted by the emergence of newer and more effective antiretroviral drugs. However, it still plays a role in certain treatment regimens, especially in regions where access to newer drugs is limited.

Cost-Effectiveness

Studies have shown that generic versions of zidovudine can be very cost-effective. For example, a cost-effectiveness analysis highlighted significant savings associated with the use of generic efavirenz and other generic NRTIs, including zidovudine[2].

Competitive Landscape

The anti-retroviral drugs market is highly competitive, with key players such as Gilead Sciences, ViiV Healthcare, and Merck & Co. engaging in strategic initiatives like mergers, acquisitions, and partnerships to strengthen their product portfolios. Gilead Sciences, in particular, dominates the US HIV drug market with over 60% market share, largely due to its blockbuster drug Biktarvy[3].

Challenges and Opportunities

Pricing and Affordability

High costs of HIV medications remain a significant barrier to treatment, especially for those without sufficient insurance coverage or financial resources. This challenge necessitates continued efforts to make antiretroviral drugs more affordable[3].

Stigma and Access

Addressing stigma and ensuring greater access to treatment, particularly in underdeveloped nations, are critical for the growth of the market. Efforts to eliminate affordability limitations and increase awareness are ongoing[3].

Impact of COVID-19

The COVID-19 pandemic initially surged the demand for antiretroviral drugs due to their potential use in treating COVID-19. However, with the decrease in COVID-19 cases and the availability of other COVID-19 treatments, the market has returned to its pre-pandemic growth trajectory[4].

Key Takeaways

• The global anti-retroviral drugs market is projected to grow significantly, driven by rising HIV prevalence and advancements in drug development.
• Generic antiretroviral drugs offer substantial cost savings and are increasingly important in the market.
• North America is expected to dominate the market due to technological advancements and a high number of HIV cases.
• RETROVIR, while historically significant, faces competition from newer drugs but remains cost-effective in certain treatment regimens.
• Addressing affordability and access issues remains crucial for market growth.

FAQs

What is the current market size of the anti-retroviral drugs market?

The global anti-retroviral drugs market was valued at USD 29.1 billion in 2023[1].

What is the projected growth rate of the anti-retroviral drugs market?

The market is anticipated to grow at a CAGR of 4.2% from 2024 to 2032[1].

Which region is expected to dominate the anti-retroviral drugs market?

North America is expected to dominate the market throughout the forecast period due to the presence of key market players and a high number of HIV cases[1][4].

How do generic antiretroviral drugs impact the market?

Generic antiretroviral drugs significantly reduce costs and are expected to continue gaining market share as patents for branded drugs expire[2][3].

What are the main challenges facing the anti-retroviral drugs market?

High costs of medications, patent expiration, and access limitations are significant challenges. Addressing stigma and ensuring greater access to treatment are also critical[3].

Sources

1. GMI Insights: Anti-retroviral Drugs Market Size & Share – Trends Report, 2032
2. Clinical Info HIV.gov: Cost Considerations and Antiretroviral Therapy
3. Insights10: US HIV Drugs Market Analysis Report 2022 to 2030
4. Mordor Intelligence: Anti-Retroviral Drugs Market Size & Share Analysis - Growth Trends