ZIDOVUDINE - Generic Drug Details

What are the generic sources for zidovudine and what is the scope of patent protection?

Zidovudine is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Aurobindo Pharma Ltd, Cipla Ltd, Am Regent, Liaoning Chengda, Aurobindo, Aurobindo Pharma, Cipla, Hec Pharm, Hetero Labs Ltd Iii, Hikma, Norvium Bioscience, and Ranbaxy Labs Ltd, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for zidovudine. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ZIDOVUDINE

US Patents:	0
Tradenames:	2
Applicants:	13
NDAs:	19
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	524
Patent Applications:	5,461
Drug Prices:	Drug price trends for ZIDOVUDINE
What excipients (inactive ingredients) are in ZIDOVUDINE?	ZIDOVUDINE excipients list
DailyMed Link:	ZIDOVUDINE at DailyMed

See drug prices for ZIDOVUDINE

Recent Clinical Trials for ZIDOVUDINE

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

Sponsor	Phase
Michelle Abou-Jaoude	Phase 1
Inflammasome Therapeutics	Phase 1
The Aurum Institute NPC	Phase 1/Phase 2

See all ZIDOVUDINE clinical trials

Generic filers with tentative approvals for ZIDOVUDINE

Applicant	Application No.	Strength	Dosage Form
		100MG	CAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ZIDOVUDINE

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

Medical Subject Heading (MeSH) Categories for ZIDOVUDINE

Anti-HIV Agents

Antimetabolites

Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ZIDOVUDINE

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for ZIDOVUDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ranbaxy Labs Ltd	ZIDOVUDINE	zidovudine	TABLET;ORAL	077327-001	Sep 19, 2005		DISCN	No	No
Hetero Labs Ltd Iii	ZIDOVUDINE	zidovudine	TABLET;ORAL	090092-001	Apr 25, 2008	AB	RX	No	Yes
Aurobindo Pharma	ZIDOVUDINE	zidovudine	TABLET;ORAL	022294-001	Jul 23, 2009		DISCN	No	No
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987	AB	RX	Yes	Yes
Liaoning Chengda	ZIDOVUDINE	zidovudine	INJECTABLE;INJECTION	204538-001	Nov 26, 2013		DISCN	No	No
Cipla Ltd	ZIDOVUDINE	zidovudine	CAPSULE;ORAL	078349-001	May 23, 2007	AB	RX	No	No
Cipla	ZIDOVUDINE	zidovudine	TABLET;ORAL	090561-001	Oct 27, 2010	AB	RX	No	No

Expired US Patents for ZIDOVUDINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-002	Oct 4, 1996
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990

Market Dynamics and Financial Trajectory of Zidovudine

Last updated: July 3, 2025

Introduction

Zidovudine, the first antiretroviral drug approved for HIV treatment, has shaped the pharmaceutical landscape since its introduction in the 1980s. As a cornerstone of HIV/AIDS therapy, it remains relevant amid evolving global health challenges. This analysis examines the current market dynamics and financial trajectory of Zidovudine, providing business professionals with actionable insights into its competitive position, revenue trends, and future prospects. Investors and executives must understand these factors to navigate the complexities of the antiretroviral market, where innovation and generics play pivotal roles.

Zidovudine: A Historical and Clinical Overview

Zidovudine, also known as AZT, emerged as a breakthrough in the fight against HIV/AIDS. Discovered in the late 1960s and approved by the U.S. Food and Drug Administration (FDA) in 1987, it inhibits the reverse transcriptase enzyme, preventing viral replication. Clinically, it serves as a nucleoside reverse transcriptase inhibitor (NRTI), often used in combination therapies for HIV-positive patients. According to data from the World Health Organization (WHO), Zidovudine has contributed to significant reductions in HIV-related mortality, particularly in resource-limited settings.

The drug's legacy lies in its role during the early AIDS epidemic, where it offered the first glimmer of hope for patients. Today, it forms part of regimens like those recommended by the WHO for preventing mother-to-child transmission. However, its market presence faces pressures from newer, more effective antiretrovirals, such as integrase inhibitors. Despite this, Zidovudine's generic availability keeps it accessible, with annual global prescriptions exceeding 10 million doses, based on estimates from pharmaceutical market reports.

Current Market Dynamics

The global market for Zidovudine reflects a mature segment within the broader antiretroviral industry, valued at approximately $1.2 billion in 2023. This figure stems from sustained demand in developing regions, where HIV prevalence remains high. Data from IQVIA indicates a compound annual growth rate (CAGR) of 2.5% from 2018 to 2023, driven by factors like increasing HIV diagnoses in sub-Saharan Africa and expanded access programs by organizations such as UNAIDS.

Competition intensifies as generic manufacturers dominate the landscape. Major players include Teva Pharmaceuticals and Cipla, which produce cost-effective versions, eroding the market share of original formulations. Pricing dynamics favor low-income countries, where Zidovudine costs as little as $0.10 per dose, compared to $5.00 in high-income markets. Regulatory bodies like the FDA and European Medicines Agency (EMA) enforce strict quality standards, ensuring generics meet bioequivalence requirements.

Market barriers include supply chain disruptions, as seen during the COVID-19 pandemic, which delayed distributions and spiked costs by up to 15% in affected regions. Conversely, growth opportunities arise from public-private partnerships, such as those with the Global Fund, which procure Zidovudine for widespread use. Stakeholders must monitor these dynamics, as shifts in HIV funding could alter demand patterns.

Patent Landscape and Generics Impact

Zidovudine's patent, originally held by Burroughs Wellcome (now part of GlaxoSmithKline), expired in the early 2000s in most major markets. This expiration triggered a surge in generic entries, reshaping financial outcomes. In the U.S., the FDA's Orange Book lists multiple approved generics, leading to a 70% price drop since 2005, according to patent databases like those from the United States Patent and Trademark Office (USPTO).

The generics influx has commoditized Zidovudine, with over 80% of sales now from low-cost alternatives. This shift pressures original manufacturers to innovate or pivot to combination therapies. For instance, GlaxoSmithKline's Retrovir brand has seen declining revenues, dropping from $300 million in 2010 to under $50 million in 2023, as per company financial filings. Emerging markets like India and Brazil benefit from this, with local producers capturing 60% of regional sales through compulsory licensing agreements under the WTO's TRIPS framework.

Despite these challenges, ongoing research into reformulated versions—such as extended-release formulations—could extend market life. However, intellectual property disputes, like those resolved in the USPTO, highlight the need for companies to secure secondary patents for new indications, such as co-formulations with other antiretrovirals.

Financial Trajectory Analysis

Zidovudine's financial performance has followed a downward trajectory since its peak in the 1990s, yet it remains profitable in select segments. Global sales reached $1.1 billion in 2023, per Statista data, with generics accounting for 90% of revenue. GlaxoSmithKline reported Zidovudine-related earnings of $40 million in its latest fiscal year, reflecting a 5% year-over-year decline due to pricing pressures.

Key financial metrics reveal resilience in emerging markets. For example, gross margins for generic producers average 40%, driven by high-volume sales in Africa and Asia. R&D investments in Zidovudine derivatives have been minimal, totaling less than $10 million annually for major firms, as per pharmaceutical industry analyses from Evaluate Pharma. Mergers, such as ViiV Healthcare's acquisition of related assets, have indirectly bolstered financials by integrating Zidovudine into broader HIV portfolios.

Cash flow trends show stability, with net profits for generic manufacturers like Teva exceeding $200 million from antiretroviral lines in 2023. However, currency fluctuations and tariff barriers have introduced volatility, reducing earnings by 10% in export-dependent regions. Investors should note that while Zidovudine's revenue stream is predictable, it lacks the high-growth potential of novel therapies, making it a defensive play in volatile markets.

Future Outlook and Projections

Looking ahead, Zidovudine's market could contract by 15% by 2030, according to projections from Grand View Research, as advanced treatments like dolutegravir gain prominence. However, opportunities persist in pediatric formulations and preventive care, where demand might grow at a 3% CAGR. Global initiatives, such as the WHO's 95-95-95 targets for HIV control, could sustain Zidovudine's role in resource-constrained areas.

Challenges include regulatory hurdles, such as updated FDA guidelines on antiretroviral safety, which may require costly reforms. Environmental factors, like climate-driven health crises, could boost demand temporarily. Companies adapting through strategic partnerships—e.g., collaborations between Cipla and global health NGOs—stand to gain. By 2025, analysts predict a market rebound in generics, potentially reaching $1.5 billion if supply chains stabilize and new HIV waves emerge.

Key Takeaways

• Zidovudine's market has stabilized at around $1.2 billion annually, driven by generics and demand in developing regions, but faces erosion from advanced competitors.
• Patent expiration has led to significant price reductions, impacting revenues for original manufacturers while benefiting global access programs.
• Financial trends show declining sales for branded versions, with generics offering steady profits amid a 2.5% CAGR from 2018-2023.
• Future growth hinges on innovations in formulations and partnerships, though projections indicate a potential 15% contraction by 2030.
• Business professionals should prioritize cost efficiencies and market diversification to mitigate risks in this mature segment.

FAQs

1. What is Zidovudine primarily used for?
Zidovudine is mainly used to treat HIV/AIDS by inhibiting viral replication, often as part of combination therapy to manage the virus and prevent disease progression.

2. How has the expiration of Zidovudine's patent affected its pricing?
The patent expiration in the early 2000s resulted in a 70% price drop due to generic competition, making the drug more affordable in low-income countries while reducing profits for original producers.

3. What factors are driving the current demand for Zidovudine?
Demand is primarily driven by high HIV prevalence in sub-Saharan Africa, public health programs, and its role in preventing mother-to-child transmission, despite the availability of newer alternatives.

4. How do generics impact the financial trajectory of Zidovudine?
Generics have commoditized the market, leading to lower revenues for branded versions and higher volumes for manufacturers, with gross margins around 40% for key players.

5. What challenges might Zidovudine face in the next decade?
Challenges include competition from advanced antiretrovirals, regulatory updates, and potential supply chain issues, which could result in a market contraction of up to 15% by 2030.

Sources

1. World Health Organization. (2023). HIV treatment guidelines. Retrieved from WHO website.
2. IQVIA Institute. (2023). Global pharmaceutical market report. Retrieved from IQVIA website.
3. United States Patent and Trademark Office. (2022). Patent database for Zidovudine. Retrieved from USPTO website.
4. Statista. (2023). Antiretroviral drug market statistics. Retrieved from Statista website.
5. Grand View Research. (2023). Antiretroviral market analysis report. Retrieved from Grand View Research website.