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:	82
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	TABLET;ORAL	020518-001	Dec 19, 1995	4,837,208
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995	4,828,838
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990	4,818,538
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-002	Oct 4, 1996	4,818,538
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995	4,724,232

International Patents for RETROVIR

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

Country	Patent Number	Title	Estimated Expiration
Austria	A68386
Singapore	62889
Spain	557835
Spain	557836
Australia	572019

Supplementary Protection Certificates for RETROVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for Retrovir (Zidovudine)

Last updated: July 28, 2025

Introduction

Retrovir (generic name: zidovudine) has been a cornerstone in the treatment of HIV/AIDS since its approval in 1987. As one of the pioneering antiretroviral agents, Retrovir has shaped the landscape of HIV therapy while navigating complex market dynamics driven by patent protections, evolving treatment guidelines, and emerging competitors. This report provides an in-depth analysis of the current market environment and financial outlook for Retrovir, offering insights vital for stakeholders, investors, and healthcare decision-makers.

Historical and Regulatory Overview

Retrovir was developed by GlaxoSmithKline (GSK), originally marketed under the name AZT. It gained FDA approval as the first antiretroviral drug, revolutionizing HIV management. Over the years, the patent for Retrovir expired globally, paving the way for generic manufacturing, which significantly impacted its market exclusivity and pricing.

In recent years, regulatory authorities have approved numerous fixed-dose combinations (FDCs) incorporating zidovudine, expanding treatment options for HIV-positive patients. Regulatory barriers are less prominent now; however, patent and exclusivity rights continue to affect market positioning, especially in patents on formulations or new delivery methods.

Market Dynamics

1. Patent Expiry and Generic Competition

The expiration of the original patent rights for Retrovir has led to the proliferation of generic versions worldwide. Generic manufacturers typically enter markets at substantially lower prices, exerting downward pressure on the brand-name product’s sales. This influx has notably reduced Retrovir’s market share in regions where generics are widely available, especially in low- and middle-income countries (LMICs).

2. Pricing Strategies and Market Penetration

Price competition remains fierce post-patent expiry. GSK and other originators often rely on differential pricing, service differentiation, and patient support programs to maintain a competitive edge. However, in markets with strong patent laws and effective generic procurement mechanisms, prices for retroviral drugs tend to stabilize at lower levels, reducing profit margins for brand-name products.

3. Evolving Treatment Guidelines

Treatment protocols for HIV have shifted toward integrase inhibitor-based regimens, which offer improved efficacy and tolerability. While zidovudine remains a component of certain first-line therapies, its usage has declined in favor of newer agents. Nonetheless, zidovudine persists as a second-line or salvage therapy, especially in resource-constrained settings.

4. Global HIV/AIDS Market Trends

According to UNAIDS, over 38 million people globally are living with HIV, with significant treatment coverage—approaching 28 million on antiretroviral therapy as of 2021 [1]. The demand for affordable antiretrovirals remains high, underpinning the sustained market for older drugs like Retrovir, particularly in LMICs. However, with continual development of newer, more convenient, and better-tolerated drugs, Retrovir’s market share continues to diminish.

5. Market Segmentation and Geographic Dynamics

• Developed Markets: High adoption of newer agents has led to decreased Retrovir prescriptions, although it still serves as part of combination therapies in certain cases.
• Emerging and Low-Income Countries: Reliance on generic formulations sustains Retrovir’s relevance due to cost-effectiveness and established supply networks. International donors and global health initiatives like GAVI and PEPFAR significantly influence purchasing patterns.

Financial Trajectory and Commercial Outlook

1. Revenue Trends

The revenues for Retrovir have declined markedly since patent expiration. GSK’s consolidated revenues from Retrovir and its generics have similarly dipped, reflecting generic price erosion and shifting market preferences. While exact numbers vary by region, industry estimates suggest a steady decline of approximately 10-15% annually post-2015 [2].

2. Profitability and Margins

Profit margins for Retrovir derived from the brand-name product have contracted due to next-generation antiretrovirals capturing market share and intense price competition among generic producers. Margins may continue shrinking unless manufacturers innovate through formulation improvements or combination products.

3. Investment and R&D Considerations

Despite declining revenues, sustained pharmaceutical investments are necessary for developing improved formulations, novel delivery mechanisms, or focused therapies for resistant HIV strains. GSK has selectively maintained R&D efforts to explore combinatorial formulations, which could revive interest and sales.

4. Impact of Consolidation and Patent Strategies

Consolidation in the pharmaceutical industry and strategic patent filings—such as secondary patents on formulations or delivery methods—may temporarily buffer declines. However, the global trend toward biosimilarity and generic proliferation lessens the long-term impact of such strategies.

5. Future Market Opportunities

While the traditional Retrovir product faces a shrinking market, opportunities persist in:

• Vertical Integration: Developing fixed-dose combination therapies including zidovudine by generic manufacturers.
• Patent Extensions: Securing patents on new formulations to extend market exclusivity.
• Market Penetration in LMICs: Maintaining supply through global health programs by offering low-cost generics.

Challenges and Risks

• Price Erosion: Continued availability of cheaper generics threatens revenues.
• Therapeutic Preference Shift: Adoption of newer drugs diminishes Retrovir's relevance.
• Regulatory Changes: Variations in patent laws and international trade agreements impact market access.
• Resistance Development: Emergence of drug-resistant HIV strains may necessitate formulation modifications or alternative therapies.
• Funding Limitations: Dependence on global health programs, affected by funding shifts, may influence procurement volumes.

Strategic Implications for Stakeholders

• Pharmaceutical Companies: Focus on lifecycle management through formulation improvements, combination therapies, or niche indications.
• Investors: Consider the declining revenue trajectory but recognize potential in emerging formulations and markets.
• Healthcare Providers: Balance the affordability of generics with the evolving landscape favoring newer therapies.
• Policy Makers: Facilitate affordable access while promoting innovation to meet changing clinical needs.

Key Takeaways

• The patent expiry of Retrovir has significantly transformed its market landscape, leading to aggressive generic competition and declining revenues.
• In high-income markets, Retrovir’s role diminishes as newer antiretroviral agents dominate treatment protocols.
• In LMICs and via global health programs, Retrovir remains vital due to its cost-effectiveness and established supply chains.
• Opportunities for extended market relevance exist through formulation innovation, strategic patenting, and targeted niche markets.
• The overall financial trajectory for Retrovir is characterized by de-escalation, with sustained relevance primarily in resource-constrained settings.

Conclusion

Retrovir exemplifies the classic lifecycle of pioneering pharmaceuticals facing patent expiration and market saturation. While primary revenues decline, strategic maneuvering—such as formulation innovation and market segmentation—can prolong its commercial viability. Stakeholders leveraging these insights can better navigate the evolving landscape, balancing affordability with innovation to optimize clinical and financial outcomes.

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FAQs

Q1: How does patent expiration affect Retrovir’s market dynamics?
Patent expiration opens the door for generic manufacturers, increasing competition, reducing prices, and decreasing revenue for the original patent holder. This shift typically leads to a decline in market share for the branded product.

Q2: Are there ongoing efforts to reformulate Retrovir or extend its patent?
Yes, companies may seek secondary patents on new formulations or delivery methods, but such strategies face legal and regulatory challenges, especially after patent law harmonization efforts.

Q3: What role does Retrovir play in current HIV treatment guidelines?
While its use has declined in high-income countries, Retrovir remains part of certain second-line therapies and fixed-dose combinations, particularly in resource-limited settings due to cost and established safety profiles.

Q4: How significant are global health programs to Retrovir’s continued market presence?
Very significant. Initiatives like PEPFAR and GAVI procure large volumes of affordable generics, ensuring ongoing demand in developing regions.

Q5: What are the future growth prospects for Retrovir?
Primary prospects lie in niche applications, formulation improvements, or markets where cost and supply chain infrastructure favor older generics. Overall, its growth is limited by the dominance of newer antiretroviral drugs.

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References

[1] UNAIDS. Global HIV & AIDS statistics — 2022 fact sheet. Available at: https://unaids.org/en/resources/fact-sheet
[2] IQVIA. Market dynamics report on antiretroviral drugs — 2022.