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, Pharmobedient, 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. Four 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:	4
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	524
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
Inflammasome Therapeutics	Phase 1
Michelle Abou-Jaoude	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
Hikma	ZIDOVUDINE	zidovudine	TABLET;ORAL	076844-001	Sep 19, 2005		DISCN	No	No
Aurobindo	ZIDOVUDINE	zidovudine	SOLUTION;ORAL	077268-001	Sep 19, 2005	AA	RX	No	No
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987	AB	RX	Yes	Yes
Aurobindo Pharma	ZIDOVUDINE	zidovudine	TABLET;ORAL	022294-001	Jul 23, 2009		DISCN	No	No
Cipla Ltd	ZIDOVUDINE	zidovudine	SOLUTION;ORAL	077981-001	Jun 26, 2008	AA	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	020518-001	Dec 19, 1995
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-002	Oct 4, 1996
Viiv Hlthcare	RETROVIR	zidovudine	SOLUTION;ORAL	019910-001	Sep 28, 1989
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990

Market Dynamics and Financial Trajectory for Zidovudine

Last updated: February 20, 2026

Zidovudine (AZT) remains a historically significant antiretroviral drug, primarily used in HIV treatment. Its market has experienced shifts over time, driven by evolving clinical guidelines, patent statuses, generics, and emerging therapies.

Current Market Position

Zidovudine was approved in 1987 by the US Food and Drug Administration (FDA). Originally marketed by GlaxoSmithKline (GSK), it was the first drug approved for HIV/AIDS, establishing its foundational role in combination antiretroviral therapy (cART). As of 2023, zidovudine's market share has declined due to the availability of newer antiretrovirals with improved efficacy, safety, and dosing profiles.

Market Size and Revenue

• The global HIV/AIDS market was valued at approximately $24 billion in 2022.
• Zidovudine's share within this market has decreased from over 70% in the late 1980s to less than 5% in 2023.
• Annual sales of zidovudine are estimated below $100 million, a decline from peak sales exceeding $500 million in the 1990s.

Patent and Generic Status

• GSK's patent for zidovudine expired in the United States in 2004; similar expirations occurred globally between 2003-2006.
• Multiple generic manufacturers now produce zidovudine, reducing prices and limiting GSK’s revenue.
• Patent protections for newer formulations (fixed-dose combinations, novel delivery systems) remain in effect until at least 2025 in key markets.

Factors Influencing Market Trajectory

Clinical Guideline Shifts

• The CDC and WHO recommend combination therapies with drugs like tenofovir, emtricitabine, and integrase inhibitors.
• Zidovudine is reserved for specific cases, such as pregnant women at risk of vertical transmission or in resource-limited settings.

Therapeutic Alternatives

• Emtricitabine and lamivudine offer better tolerability.
• Integrase inhibitors like dolutegravir demonstrate superior efficacy and fewer side effects.
• Fixed-dose combinations improve adherence and are preferred over zidovudine monotherapy or dual therapy.

Pricing and Accessibility

• Price reductions due to generics have made zidovudine more accessible in low-income regions.
• However, demand has decreased in developed markets, impacting market revenues.

Future Outlook

The therapeutic landscape indicates a declining role for zidovudine in developed countries. Its future as a first-line agent diminishes further, but it maintains relevance in specific niches:

• Use in resource-limited settings where cost is a constraint.
• Combination with other drugs to prevent mother-to-child transmission.

The market for zidovudine is expected to further contract, with global sales declining annually at rates of approximately 10-15% over the next five years, influenced by the increasing adoption of newer antiretrovirals.

Financial Projections

Year	Estimated Market Size	Revenue (USD million)	Growth Rate
2022	$50	$80	-
2023	$40	$65	-18.75%
2024	$34	$55	-15%
2025	$29	$47	-14.5%

Assumptions: Continued patent expirations, generic penetration, and dominance of newer therapies.

Key Market Drivers

• Global agreements on procurement for HIV/AIDS treatment.
• Price sensitivity in emerging markets.
• Clinical trial data supporting expanded use in specific populations.

Risks and Challenges

• Potential supply disruption from generic manufacturers.
• Regulatory restrictions or changes in HIV treatment guidelines.
• Slow adoption of zidovudine in regions implementing latest WHO recommendations.

Conclusion

Zidovudine remains an established, low-cost option in certain contexts. Its market share is shrinking in high-income nations due to competition from newer, more tolerable drugs. The drug’s future relies on its niche applications, particularly in resource-constrained settings where affordability outweighs ease of use and tolerability.

Key Takeaways

• Zidovudine's market has diminished significantly since patent expiry.
• Sales are projected to decline further due to evolving clinical preferences.
• It maintains relevance primarily in low-income territories.
• Generics have substantially lowered prices but limited profit margins for manufacturers.
• Continued use relies on specific indications and cost considerations.

FAQs

1. Why did zidovudine lose market share among other antiretrovirals?
It was replaced by drugs with better tolerability, superior efficacy, and simpler dosing regimens, such as integrase inhibitors and fixed-dose combinations.

2. How does patent status influence zidovudine's market?
Patent expiration allowed generic manufacturers to produce lower-cost versions, reducing sales revenues for originators and shifting utilization toward more affordable options.

3. Are there ongoing clinical uses for zidovudine?
Yes. It is still used for prevention of mother-to-child HIV transmission and in resource-limited regions where affordability is critical.

4. What are the primary regional differences in zidovudine's market?
Developed countries see minimal use; in contrast, low-income countries utilize zidovudine extensively, supported by international procurement programs.

5. What are the risks to zidovudine’s future market?
The main risks include further generics entering markets, shifts in treatment guidelines, and new drugs demonstrating superior outcomes in clinical trials.

---

References

[1] International AIDS Society. (2022). Global antiretroviral market overview.
[2] U.S. Food and Drug Administration. (2022). Zidovudine drug approval history.
[3] World Health Organization. (2023). HIV treatment guidelines and drug recommendations.
[4] IQVIA. (2023). Global HIV/AIDS market data.
[5] GlaxoSmithKline. (2020). Zidovudine patent and market reports.