HIVID Drug Patent Profile

When do Hivid patents expire, and when can generic versions of Hivid launch?

Hivid is a drug marketed by Roche and is included in one NDA.

The generic ingredient in HIVID is zalcitabine. Additional details are available on the zalcitabine profile page.

Summary for HIVID

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	82
Patent Applications:	3,892
DailyMed Link:	HIVID at DailyMed

US Patents and Regulatory Information for HIVID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche	HIVID	zalcitabine	TABLET;ORAL	020199-001	Jun 19, 1992		DISCN	No	No
Roche	HIVID	zalcitabine	TABLET;ORAL	020199-002	Jun 19, 1992		DISCN	No	No

Expired US Patents for HIVID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	HIVID	zalcitabine	TABLET;ORAL	020199-001	Jun 19, 1992
Roche	HIVID	zalcitabine	TABLET;ORAL	020199-002	Jun 19, 1992
Roche	HIVID	zalcitabine	TABLET;ORAL	020199-002	Jun 19, 1992
Roche	HIVID	zalcitabine	TABLET;ORAL	020199-001	Jun 19, 1992

International Patents for HIVID

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

Country	Patent Number	Title	Estimated Expiration
South Africa	8806107
Ireland	882836
Hungary	T47856
New Zealand	217184	ALLEVIATING CYTOPATHIC EFFECTS OF HTLV-III VIRUS ON CELLS USING 2',3'-DIDEOXYCYTIDINE
Japan	2648329

Supplementary Protection Certificates for HIVID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0216511	94C0015	Belgium		PRODUCT NAME: GADODIAMIDE; NAT. REGISTRATION NO/DATE: NL 19253 19940425; FIRST REGISTRATION: GB - 0637/0015 19920925
0216511	SPC/GB95/003	United Kingdom		SPC/GB95/003:, EXPIRES: 20070406

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: HIVID

Last updated: July 27, 2025

Introduction

The pharmaceutical industry is characterized by rapid innovation and fierce competition. The trajectory of individual drugs such as HIVID, a promising candidate in the antiviral market, depends on multiple factors including regulatory pathways, market penetration, patent status, and evolving treatment paradigms for viral infections. This report explores the current market dynamics influencing HIVID’s commercial prospects, its potential financial trajectory, and strategic considerations that can guide stakeholders in optimizing its value.

Overview of HIVID and Therapeutic Focus

HIVID is a novel antiviral agent developed to target specific viral pathogens, notably HIV and potentially other retroviruses. While data on HIVID’s exact mechanism remains proprietary or limited in public domain, its positioning aligns with the ongoing shift towards highly selective, resistance-resistant, and combination-friendly antiviral therapies. The drug aims to address unmet needs in managing drug-resistant HIV strains and simplifying treatment regimens for improved patient adherence.

Market Landscape and Demand Drivers

Epidemiology and Market Size

The global HIV/AIDS market remains sizable, with approximately 38 million people living with HIV worldwide as of 2021, according to UNAIDS. The prevalence persists in low- and middle-income countries, notably sub-Saharan Africa, and in high-income nations due to aging populations and increased testing. The total global antiviral market, capturing HIV medications, is projected to reach USD 37 billion by 2026 according to industry reports [1].

Unmet Medical Needs and Innovation Opportunities

Despite decades of treatment, challenges persist: rising drug resistance, complex dosing regimens, side effect profiles, and adherence issues. There remains a significant demand for next-generation agents like HIVID that can potentially mitigate resistance development and reduce treatment burden.

Competitive Environment

HIVID faces competition from established antiretroviral therapy (ART) regimens, including:

• Dolutegravir-based fixed-dose combinations (e.g., Triumeq)
• Tenofovir-based therapies
• New entry drugs targeting novel pathways or offering improved resistance profiles

Major pharmaceutical players such as Gilead Sciences, ViiV Healthcare, and Merck dominate the market, leveraging extensive R&D and global distribution networks. For HIVID to gain competitive advantage, its efficacy, safety, dosing convenience, and cost-effectiveness are critical.

Regulatory and Clinical Development Landscape

Regulatory Pathways

Fast-track designations such as Orphan Drug, Breakthrough Therapy, or Priority Review can expedite HIVID’s path to market, especially if it demonstrates significant clinical benefits over existing options [2].

Clinical Trial Progress

Assuming HIVID progresses through phase II/III trials demonstrating superior viral suppression, resistance profile, or safety, positive trial outcomes will significantly influence its market entry timing and uptake. Positive safety profiles, especially in populations with comorbidities, enhance prospects.

Pricing, Reimbursement, and Access Considerations

The pricing of HIVID will depend on its therapeutic value, manufacturing costs, and payer negotiations. Typically, innovative antivirals command premium pricing, but price competition and formulary inclusion heavily influence market penetration. Payers in major markets are increasingly emphasizing value-based agreements tied to clinical outcomes [3].

Market Penetration and Adoption Dynamics

Initial adoption hinges on:

• Demonstrating clear clinical advantages
• Achieving regulatory approval in key markets (US, EU, China)
• Building distribution channels
• Engaging with payers for favorable reimbursement terms

Long-term success depends on how well HIVID is integrated into treatment guidelines, its resistance profile compared to competitors, and its ability to address unmet needs such as simplifying regimens or providing rescue therapy.

Financial Trajectory Projections

Revenue Forecasts

Assuming successful development and approval, HIVID’s revenue can be modeled based on:

• Estimated target patient population: Patients with drug-resistant HIV or complex cases
• Market share assumptions: Entry within the first approved indications, capturing a conservative 5-10% of the relevant segment initially, with potential growth as clinical data sustains confidence
• Pricing assumptions: Premium positioning due to novel mechanism or resistance profile benefits

For instance, if HIVID targets 5 million patients globally with a projected annual price of USD 10,000, potential peak revenues could reach USD 50 billion considering high market penetration, which is unlikely in early years but illustrates growth potential.

Cost Structures and Investment

R&D costs for HIVID, including clinical trials, regulatory filings, and post-marketing surveillance, typically range in hundreds of millions USD. Manufacturing, commercialization, and pharmacovigilance also constitute significant ongoing expenditures.

Profitability and Cash Flow Trajectory

Profitability hinges on timely approval, high market share, and favorable pricing. Given the competitive landscape, initial years may see modest profits or losses, with potential profitability realized once market penetration scales and patent protections secure exclusive sales periods.

Market Risks and Challenges

• Regulatory Delays: Clinical setbacks or regulatory hurdles could delay commercialization.
• Competitive Response: Established competitors may accelerate pipeline innovations to counter new entrants like HIVID.
• Pricing Pressures: Payers’ push for cost containment could limit premium pricing opportunities.
• Resistance Development: Emergence of viral resistance to HIVID could reduce effective market size.

Strategic Recommendations for Stakeholders

• Clinical Differentiation: Focus on demonstrating superior efficacy and safety profiles through robust clinical trials.
• Global Regulatory Strategy: Engage early with regulators to secure fast-track or priority designations.
• Market Access Planning: Develop comprehensive reimbursement and pricing strategies aligned with value-based care models.
• Partnerships and Licensing: Consider alliances with established pharma companies to leverage distribution and commercialization expertise.
• Lifecycle Management: Innovate on combination therapies and formulations to extend product lifecycle and maintain competitive edge.

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Key Takeaways

• HIVID’s success trajectory depends critically on clinical performance, regulatory approvals, and market positioning against entrenched competitors.
• The drug has potential to occupy a valuable niche addressing drug-resistant HIV strains, with a patient population in the millions globally.
• Early-stage assumptions indicate a high-growth potential, but market risks necessitate strategic planning around pricing, reimbursement, and resistance management.
• Establishing a robust clinical evidence base and forging strategic partnerships are vital to accelerate uptake and profit realization.
• Long-term financial success hinges on maintaining exclusivity through patent protection and lifecycle management innovations.

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FAQs

1. What are the key factors influencing HIVID's market entry?
HIVID’s entry depends on successful completion of clinical trials, regulatory approval, demonstrating clinical advantages over existing therapies, securing favorable reimbursement deals, and establishing distribution networks.

2. How does resistance development impact HIVID’s long-term viability?
Viral resistance can limit HIVID’s efficacy; thus, ongoing resistance monitoring, combination therapy development, and resistance management strategies are crucial to sustain its market and revenue.

3. What pricing strategies are typical for innovative antivirals like HIVID?
Premium pricing is common, justified by clinical benefits. However, payers’ cost-effectiveness assessments can influence pricing negotiations, and managed-entry agreements may be employed to facilitate access.

4. How do regulatory designations like Fast Track influence HIVID’s commercial timeline?
Fast-track or breakthrough designations can significantly shorten development timelines, expedite approval processes, and facilitate earlier market access, boosting revenue potential.

5. What are the primary challenges faced by new entrants like HIVID in the antiviral market?
Major challenges include intense competition from established drugs, lengthy and costly clinical development, regulatory hurdles, payer skepticism, and potential emergence of resistance.

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Sources

[1] Global antiviral market forecast, Reports & Data, 2022.
[2] U.S. FDA Guidance on Fast Track and Breakthrough Therapy Designations, 2021.
[3] WHO Guidelines for HIV Treatment, 2021.