ZERIT Drug Patent Profile

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

Zerit is a drug marketed by Bristol and Bristol Myers Squibb and is included in three NDAs.

The generic ingredient in ZERIT is stavudine. There are fourteen drug master file entries for this compound. Additional details are available on the stavudine profile page.

Summary for ZERIT

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	3,296
Drug Prices:	Drug price information for ZERIT
What excipients (inactive ingredients) are in ZERIT?	ZERIT excipients list
DailyMed Link:	ZERIT at DailyMed

See drug prices for ZERIT

US Patents and Regulatory Information for ZERIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-001	Jun 24, 1994		DISCN	No	No
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-001	Dec 31, 2002		DISCN	No	No
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-004	Jun 24, 1994		DISCN	Yes	No
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-002	Dec 31, 2002		DISCN	No	No
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-002	Jun 24, 1994		DISCN	Yes	No
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-003	Jun 24, 1994		DISCN	Yes	No
Bristol	ZERIT	stavudine	FOR SOLUTION;ORAL	020413-001	Sep 6, 1996		DISCN	Yes	No

Expired US Patents for ZERIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-005	Jun 24, 1994
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-001	Jun 24, 1994
Bristol	ZERIT	stavudine	FOR SOLUTION;ORAL	020413-001	Sep 6, 1996
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-004	Jun 24, 1994
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-003	Jun 24, 1994
Bristol	ZERIT	stavudine	CAPSULE;ORAL	020412-002	Jun 24, 1994

EU/EMA Drug Approvals for ZERIT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Zerit	stavudine	EMEA/H/C/000110Hard capsulesZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age of three months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.Powder for oral solutionZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.	Withdrawn	no	no	no	1996-05-08

International Patents for ZERIT

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

Country	Patent Number	Title	Estimated Expiration
Finland	875544
South Korea	960000433
European Patent Office	0273277	PHARMACEUTICAL COMPOSITION COMPRISING 3'-DEOXYTHYMIDIN-2'-ENE (3'-DEOXY-2',3'-DIDEHYDROTHYMIDINE) IN TREATING PATIENTS INFECTED WITH RETROVIRUS
Netherlands	960024
Denmark	557087
Austria	77554
Luxembourg	88822

Supplementary Protection Certificates for ZERIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0383472	96C0040	Belgium		PRODUCT NAME: STAVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/009/001-009 19960509; FIRST REGISTRATION:
0273277	C960024	Netherlands		PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 - EU/1/96/009/009 19960508
0273277	SPC/GB96/049	United Kingdom		PRODUCT NAME: STAVUDINE; REGISTERED: UK EU/1/96/009/001 19960508; UK EU/1/96/009/002 19960508; UK EU/1/96/009/003 19960508; UK EU/1/96/009/004 19960508; UK EU/1/96/009/005 19960508; UK EU/1/96/009/006 19960508; UK EU/1/96/009/007 19960508; UK EU/1/96/009/008 19960508; UK EU/1/96/009/009 19960508
0273277	96C0039	Belgium		PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 19960508

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Zerit

Last updated: July 28, 2025

Introduction

Zerit, the brand name for stavudine, is an antiretroviral medication initially developed for the treatment of HIV/AIDS. Since its approval, Zerit has played a pivotal role in managing HIV infection, particularly in countries with limited access to newer therapies. This analysis explores the evolving market dynamics, competitive landscape, regulatory considerations, and financial trajectory of Zerit, assessing how shifts in therapeutic strategies and market forces influence its long-term prospects.

Historical Context and Therapeutic Profile

Zerit was first approved by the U.S. Food and Drug Administration (FDA) in 1994 as part of combination antiretroviral therapy (cART). It belongs to the class of nucleoside reverse transcriptase inhibitors (NRTIs). Early years saw considerable reliance on Zerit due to its efficacy in reducing viral load. However, its safety profile—particularly mitochondrial toxicity, peripheral neuropathy, and lactic acidosis—has constrained its long-term clinical utility ([1]).

Despite these limitations, Zerit retained significance in resource-limited settings where access to newer agents remains challenging. WHO guidelines historically integrated Zerit as a preferred or alternative first-line agent, especially in low-income countries. This duality underscores a nuanced market dynamic driven by cost considerations and toxicity profiles.

Market Dynamics

1. Competitive Landscape and Therapeutic Shifts

The global HIV market has experienced seismic shifts owing to advances in antiretroviral agents. Drugs such as tenofovir, emtricitabine, and integrase strand transfer inhibitors (INSTIs) now form the backbone of first-line therapy. These newer agents exhibit superior safety profiles and higher efficacy.

As a consequence, Zerit’s market share has declined significantly, predominantly confined to regions with limited access to advanced medications. The dominance of Tenofovir (Viread) and newer fixed-dose combinations (FDCs) diminishes Zerit’s relevance in high-income markets. Nonetheless, the low cost and existing manufacturing infrastructure sustain its presence in low-income regions, especially where patent protections have expired or are unenforced.

2. Regulatory Environment and Patent Status

Zerit’s patent protection expired in many jurisdictions by the early 2000s, leading to increased generic manufacturing. The surge in generics has decreased drug prices, further entrenching Zerit as a cost-effective option in resource-constrained settings.

Regulatory agencies in developing countries continue to list Zerit in treatment guidelines due to historical reliance and infrastructure constraints. Conversely, in high-income settings, regulatory agencies have phased out Zerit from recommended treatment regimens owing to toxicity concerns.

3. Pricing and Market Penetration

Low-cost generics have historically driven Zerit’s sales volume, especially in Africa, Asia, and Latin America. According to Global HIV/AIDS Response Progress Reports, antiretroviral procurement through organizations like WHO and PEPFAR disproportionately supplies Zerit in regions where logistics and affordability outweigh toxicity considerations.

However, the availability of safer, more tolerable drugs continues to erode Zerit's market share. The price differential has narrowed, emphasizing the importance of cost in retaining market share in developing economies. Nonetheless, in countries with limited healthcare budgets, Zerit remains a vital component of first-line regimens.

4. Clinical Practice Trends

Global shifts towards integrase inhibitors and tenofovir-based regimens are evident, reflecting updated guidelines from WHO and other health authorities. Efforts to phase out older nucleoside analogs are driven by safety concerns and better tolerability profiles. As a result, presence of Zerit in standard protocols progressively diminishes, impacting its market trajectory.

Furthermore, the increasing adoption of fixed-dose combinations simplifies adherence, but many formulations exclude Zerit due to safety issues.

Financial Trajectory

1. Revenue Trends

Since its peak in the early 2000s, Zerit’s global revenue has experienced a sharp decline. This decline correlates with the advent of newer, safer antiretrovirals and changing clinical guidelines. According to market data, the global antiretroviral drug market penciled an overall CAGR of around 10% during the last decade, driven by new drug launches; Zerit's contribution has waned correspondingly.

In low-income countries, however, large-scale procurement by international health organizations sustains minimal but steady revenue streams. The steady volume offsets lower unit prices due to generic competition, aligning with the global commitment to expanding HIV treatment access.

2. Impact of Patent Expiry and Generic Competition

Patent expirations around 2000-2005 facilitated a surge in generic Zerit formulations, compressing prices and reducing profit margins for originators. Generics manufacturer’s entry led to significant market share redistribution, primarily in Africa and Asia.

Pharmaceutical companies holding residual patents or marketing rights in specific jurisdictions may still garner limited revenue, but overall profitability from Zerit has contracted substantially. Cost reduction strategies and manufacturing efficiencies in generics further impact the revenue potential.

3. Future Financial Outlook

Looking ahead, Zerit’s financial trajectory faces multiple headwinds:

• Continued decline in use within developed markets: Due to toxicity concerns and availability of better alternatives.
• Limited pipeline innovation: Zerit’s lack of new formulations or indications reduces potential for market expansion.
• Sustainability in low-income markets: Likely to persist, driven by procurement policies emphasizing cost and existing infrastructure.

In the long term, Zerit’s revenue is predicted to stabilize at low levels, with marginal growth only in sectors reliant on cost-sensitive treatment programs. The potential for resurgence remains low absent new formulations or indications.

Regulatory and Market Challenges

Toxicity Profile: Mounting evidence correlates Zerit with adverse effects, including peripheral neuropathy and mitochondrial toxicity, which threaten regulatory approval in more markets. These safety concerns reinforce the trend of regulatory de-listing and market abandonment in high-income countries.

Global Guidelines: The WHO and other authoritative bodies increasingly recommend tenofovir-based and integrase inhibitor regimes, effectively phasing out Zerit from standard protocols. Such regulatory and clinical practice shifts directly influence market demand and stockpile strategies.

Cost considerations vs. Safety: While affordability initially favored Zerit, the long-term costs associated with managing side effects and toxicity are damaging its position. Cost-benefit analyses favor newer, safer options, constraining economic incentive for continued investment.

Conclusion

Market Dynamics: The Zerit market demonstrates a stark transition from a frontline antiretroviral agent to a secondary, low-cost option primarily serving low-income and resource-limited settings. Its decline is fueled by safer, more effective therapies and robust regulatory shifts.

Financial Trajectory: Revenue streams have diminished markedly post-patent expiries and therapeutic advances. The future of Zerit hinges on its role in low-cost primary HIV treatment programs, with marginal prospects for growth in high-income sectors.

Long-term Outlook: Zerit’s market presence is expected to plateau or shrink further, driven by safety concerns and evolving treatment standards. However, in specific geographies, its affordability sustains a niche position, albeit with limited profitability.

Key Takeaways

• Shift in Treatment Paradigms: Advances in HIV therapy and updated guidelines have phased out Zerit from most high-income and even middle-income markets.
• Generics and Patent Expiry: The proliferation of generic formulations has decreased prices and profitability but sustains distribution in low-resource settings.
• Regulatory Trends: Growing safety concerns and guideline updates pose regulatory hurdles, limiting market expansion.
• Market Sustainability: Zerit remains relevant primarily due to cost factors in low-income regions; however, its long-term prospects are constrained.
• Strategic Focus: Pharmaceutical companies should re-evaluate investments in older, toxicity-prone drugs like Zerit, prioritizing innovation and safer alternatives.

FAQs

1. Why has Zerit's market share declined globally?
The decline results from the emergence of safer, more effective antiretrovirals such as tenofovir and integrase inhibitors, coupled with safety concerns and updated clinical guidelines favoring these agents.

2. In which regions does Zerit continue to have market relevance?
Zerit remains significant primarily in low-income countries where cost constraints and existing infrastructure favor generic, affordable drugs over newer, patented formulations.

3. How does patent expiry impact Zerit’s market dynamics?
Patent expiry facilitated a surge of generic production, drastically lowering prices and reducing revenue for original developers, while increasing market availability in resource-limited settings.

4. What are the regulatory challenges facing Zerit?
Regulatory agencies increasingly restrict Zerit due to its toxicity profile, with many high-income countries removing it from treatment guidelines, affecting its marketability and acceptance.

5. Is there any potential for Zerit to be repurposed or revitalized?
Currently, no; the drug’s safety profile limits its utility, and there are no known indications beyond HIV where its benefit outweighs risks. Focus remains on developing safer, more effective therapies.

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Sources:

[1] WHO. HIV/AIDS Treatment Guidelines, 2021.
[2] Global HIV/AIDS Response Progress Reports.
[3] U.S. FDA. Stavudine (Zerit) Drug Approval and Summary.
[4] MarketWatch. Analysis of Global Antiretroviral Market, 2022.
[5] Journal of Acquired Immune Deficiency Syndromes. Safety Profiles of NRTIs, 2020.