ZERIT XR Drug Patent Profile

Which patents cover Zerit Xr, and when can generic versions of Zerit Xr launch?

Zerit Xr is a drug marketed by Bristol Myers Squibb and is included in one NDA.

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

Summary for ZERIT XR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	87
Patent Applications:	3,296
DailyMed Link:	ZERIT XR at DailyMed

US Patents and Regulatory Information for ZERIT XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-001	Dec 31, 2002		DISCN	No	No
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-004	Dec 31, 2002		DISCN	No	No
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-002	Dec 31, 2002		DISCN	No	No

Expired US Patents for ZERIT XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-003	Dec 31, 2002
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-001	Dec 31, 2002
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-004	Dec 31, 2002

EU/EMA Drug Approvals for ZERIT XR

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	Withdrawn	no	no	no	1996-05-08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 XR

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

Country	Patent Number	Title	Estimated Expiration
South Africa	200207760	Sustained release beadlets containing stavudine.
Slovakia	12822002	Perličky s trvalým uvoľňovaním obsahujúce stavudín (Sustained release beadlets containing stavudine)
Poland	366089

Supplementary Protection Certificates for ZERIT XR

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ZERIT XR

Last updated: July 30, 2025

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Introduction

ZERIT XR (stavudine extended-release), a nucleoside reverse transcriptase inhibitor (NRTI), holds a notable position in HIV therapeutics, primarily designed for combination regimens in antiretroviral therapy (ART). Its pharmacokinetic advancements in the extended-release formulation aim to improve adherence, reduce dosing frequency, and optimize therapeutic outcomes. This analysis explores the current market environment, competitive landscape, regulatory considerations, and projected financial trajectory for ZERIT XR.

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Market Landscape and Demand Drivers

Global HIV/AIDS Treatment Market

The global HIV therapeutics market is projected to reach approximately USD 30 billion by 2028, fueled by increasing prevalence, expanded access to ART, and innovations in drug formulations. According to UNAIDS, over 38 million individuals worldwide live with HIV/AIDS, with treatment coverage expanding steadily ([1]).

Key Factors Influencing Demand for ZERIT XR

• Preference for Simplified Regimens: Extended-release formulations like ZERIT XR cater to the demand for once-daily dosing, improving adherence—a critical factor in managing HIV, as non-compliance accelerates resistance development.
• Patient-Centric Formulations: Innovations that reduce pill burden align with patient preferences, especially for long-term chronic conditions like HIV.
• Regulatory Approvals & Adoption: Regulatory approval timelines and endorsement by health authorities influence market penetration.

COVID-19 Impact

The COVID-19 pandemic disrupted supply chains and slowed clinical trials but concurrently increased emphasis on oral, less frequent dosing options, potentially favoring ZERIT XR’s market strategy upon recovery.

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Competitive Landscape

Existing and Emerging Competitors

• Branded & Generic NRTIs: Drugs like tenofovir and lamivudine remain dominant; however, the market offers limited competition specifically for stavudine, especially in extended-release options.
• Other Extended-Release ART Drugs: While some drugs have modified release profiles, ZERIT XR’s niche hinges on its unique formulation and adherence benefits.
• Reformulation and Patent Dynamics: Patent expiration or expiry of prior formulations influences competitive entry; exclusivity periods protect investment and provide market leverage.

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Regulatory Status & Market Access

Approval Landscape

To date, ZERIT XR’s regulatory approval status varies globally. While WHO and many national agencies have phased out stavudine due to toxicity concerns, some regions with limited generic options may still permit its use ([2]). Securing regulatory approval for ZERIT XR necessitates demonstrating safety, efficacy, and added value over existing formulations.

Pricing & Reimbursement

Pricing strategies are central to market success. Extended-release formulations often command premium pricing; however, reimbursement challenges from payers and TB-focused health systems impact revenue potentials.

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Financial Trajectory: Projections and Factors

Revenue Potential

The revenue prospects of ZERIT XR depend on several factors:

• Market Penetration: Targeting countries with high HIV prevalence and limited access to newer ART regimens.
• Pricing Strategy: Balancing premium pricing with affordability in low-resource settings.
• Adherence Improvements: Evidence-based validation of adherence benefits will support market adoption.

Based on conservative estimations, if ZERIT XR captures 2-5% of the HIV drug market in targeted regions over the next five years, annual revenues could range from USD 50 million to USD 200 million, assuming success in regulatory approval and market access.

Cost and Investment Considerations

Manufacturing costs for extended-release formulations are typically higher due to specialized delivery systems, but economies of scale and process optimizations can mitigate expenses. Regulatory, marketing, and clinical trial investments also significantly impact profitability timelines.

Growth Opportunities

• Expansion into Adjacent Markets: Potential to expand into pediatric or resistance-prone populations.
• Combination Product Development: Combining ZERIT XR with other antiretrovirals to create fixed-dose combinations (FDCs) enhances market appeal.

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Key Challenges and Risks

• Toxicity and Safety Concerns: Stavudine’s association with peripheral neuropathy and lipodystrophy poses safety challenges; demonstrating improved safety profiles is crucial.
• Regulatory Hurdles: Navigating diverse regulatory landscapes can delay entry.
• Market Competition: Dominance of existing first-line therapies constrains market share.
• Pricing and Reimbursement Barriers: Particularly in low-income settings.

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Regulatory and Commercial Strategies

To capitalize on ZERIT XR’s potential, strategies should include:

• Comprehensive clinical data demonstrating safety and adherence benefits.
• Strategic geographic focus, prioritizing regions where stavudine remains formulated.
• Engaging with health authorities early to facilitate approval.
• Establishing partnerships with governments and NGOs for favorable market access and pricing.

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Conclusion

While ZERIT XR offers pharmacological advances that align with evolving HIV treatment paradigms, its commercial success hinges on overcoming regulatory, safety, and market challenges. The drug’s financial trajectory appears promising in high-need regions, especially if positioned as a premium adherence-enhancing therapy. Market dynamics will favor companies that strategically navigate regulations, demonstrate safety superiority, and adapt pricing models to diverse healthcare systems.

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Key Takeaways

• Demand for simplified, adherence-friendly HIV drugs propels interest in ZERIT XR’s extended-release formulation.
• Global HIV market expansion provides a viable revenue base, especially in regions still utilizing stavudine.
• Regulatory approval remains a critical hurdle due to safety concerns and market perceptions linked to stavudine’s historical profile.
• A targeted approach offering clinical evidence of safety and adherence benefits can enhance market penetration.
• Strategic partnerships and adaptive pricing are vital for maximizing profitability amid stiff competition.

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FAQs

1. What differentiates ZERIT XR from traditional stavudine formulations?
ZERIT XR provides an extended-release mechanism that allows once-daily dosing, potentially improving adherence and reducing peak-trough plasma fluctuations compared to immediate-release stavudine.

2. Why is stavudine-based therapy declining globally?
Stavudine is associated with significant long-term toxicity, including peripheral neuropathy and lipodystrophy, leading to its phased withdrawal in many markets in favor of safer alternatives.

3. Are there regulatory approvals for ZERIT XR in major HIV markets?
As of now, regulatory approval status varies. Many health authorities have deprioritized stavudine, but strategic approvals can still be pursued in specific regions or for niche indications.

4. What are the main financial risks for ZERIT XR’s commercialization?
Regulatory setbacks, safety concerns, market rejection, and pricing/reimbursement barriers pose significant financial risks that could delay or limit revenue generation.

5. How can companies ensure the successful market entry of ZERIT XR?
By demonstrating improved safety and adherence benefits via rigorous clinical data, engaging early with regulators, adopting flexible pricing strategies, and targeting regions with ongoing stavudine use.

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References

[1] UNAIDS. "Global HIV & AIDS statistics — 2022 Fact Sheet."
[2] World Health Organization. "HIV Drug Resistance Report," 2022.