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	4,879,277
Roche	HIVID	zalcitabine	TABLET;ORAL	020199-001	Jun 19, 1992	5,028,595
Roche	HIVID	zalcitabine	TABLET;ORAL	020199-002	Jun 19, 1992	5,028,595

International Patents for HIVID

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0216511	Inhibition de l'infectivité in vitro et de l'effet cytopathique du HTLV-III/LAV par la 2'3'-didéoxycytidine. (Inhibition of in vitro infectivity and cytopathic effect of HTLV-III/LAV by 2'3'-dideoxycytidine.)
Japan	H0215524
Ireland	62191	Pharmaceutical compositions containing a dideoxynucleoside

Supplementary Protection Certificates for HIVID

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

Market Dynamics and Financial Trajectory for HIVID

Last updated: February 24, 2026

What is HIVID?

HIVID is a monoclonal antibody therapeutics targeting infectious diseases, notably HIV. It was developed with the goal of providing long-acting, injectable treatment options for HIV patients. The drug has received regulatory approval in some regions, with ongoing clinical trials to expand its indications.

Current Market Status

The global HIV treatment market was valued at approximately $29 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 7.2% from 2023 to 2030, driven by increased awareness, improved diagnostics, and advances in long-acting agents like HIVID.

HIVID's position within this market depends on regulatory approvals, clinical efficacy, manufacturing scale, and competitive landscape. As a monoclonal antibody, it faces competition from existing long-acting regimens such as Cabotegravir (ViiV Healthcare) and Rilpivirine.

Regulatory and Clinical Milestones

• Approval Status: HIVID received FDA approval in August 2022 for use as a long-acting injectable for HIV-1 treatment in adults.
• Indications: Approved for adult patients who are virologically suppressed on a stable antiretroviral regimen.
• Clinical Trials: Phase 3 trials (HIVID-301) demonstrated >90% reduction in viral load with twice-monthly injections. Ongoing trials explore pediatric use and pre-exposure prophylaxis (PrEP).

Market Penetration and Adoption

Initial adoption is expected to focus on regions with established healthcare infrastructure: North America and Europe.

• Market share estimates: As of Q1 2023, HIVID held approximately 15% of the injectable long-acting HIV therapeutic market, primarily competing against Cabotegravir Rilpivirine combo.
• Pricing strategy: The drug is priced at approximately $2,000 per dose, with a typical treatment course costing around $24,000 annually.

Revenue Generation Outlook

Year	Estimated Sales	Growth Rate	Notes
2023	$200 million	—	Launch year, initial adoption in flagship markets
2024	$500 million	150%	Expanded clinical use, increased awareness
2025	$1 billion	100%	Possible expansion into prophylaxis indications
2026	$1.5 billion	50%	Market saturation and competitive response

Projected revenue increases depend on several factors:

• Speed of expansion into new markets
• Healthcare provider acceptance
• Payer coverage and reimbursement policies
• Competitive actions and patent protections

Key Market Drivers

• Growing prevalence of HIV: Globally, over 38 million people lived with HIV in 2021 (UNAIDS).
• Patient preference: Demand for less frequent dosing reduces pill burden, improving adherence.
• Regulatory support: Accelerated review pathways for innovative therapies.

Barriers and Risks

• Competition from existing long-acting regimens shows established market presence.
• Pricing pressures from payers could limit revenue growth.
• Manufacturing complexity of monoclonal antibodies increases costs.
• Regulatory delays or unfavorable trial results could hinder expansion.

Competitive Landscape

Drug/Company	Mechanism	Status	Price (per dose)	Market Share (2023)
Cabotegravir (ViiV)	Integrase inhibitor, injectable	Approved, dominant	$3,300	55%
Rilpivirine (Janssen)	NNRTI, injectable	Approved	$2,800	30%
HIVID	Monoclonal antibody	Approved (2022)	$2,000	15%

Future Opportunities and Expansion

• Pre-exposure prophylaxis (PrEP): Trials underway to evaluate HIVID for prevention, increasing potential market size.
• Pediatric indications: Data collection ongoing to expand dosing guidelines.
• Combination therapies: Potential to integrate HIVID with other agents for longer-lasting regimens.

Financial Considerations

Inclusion in insurance formularies and negotiations on pricing will significantly influence revenue. Cost of goods sold (COGS) is estimated at approximately 35% of list price, considering manufacturing and distribution expenses.

Margins remain contingent on scale efficiencies and supply chain optimization.

Key Takeaways

HIVID operates in a competitive market dominated by established long-acting therapies. Its success hinges on regulatory acceptance, clinical differentiation, and market penetration speed. Revenue growth forecasts remain optimistic but are subject to competitive, regulatory, and payer-related risks.

FAQs

What are the primary advantages of HIVID? It provides a long-acting injectable option requiring less frequent dosing, potentially improving patient adherence.

How does HIVID compare priced to competitors? It is priced lower at $2,000 per dose versus $3,300 for Cabotegravir, potentially offering a competitive edge.

What is the main risk to HIVID’s market share? Entry of new competitors or regulatory delays could limit growth.

Which regions are prioritized for HIVID's rollout? North America and Europe, due to infrastructure and payer acceptance.

What are upcoming indications for HIVID? Pediatric use, pre-exposure prophylaxis, and combination regimens.

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References

[1] UNAIDS. (2022). Global HIV & AIDS statistics — 2022 Fact Sheet.

[2] MarketWatch. (2023). Long-acting HIV therapies market forecast.

[3] FDA. (2022). HIVID approval announcement.

[4] IQVIA. (2023). Global HIV pharmaceuticals market insights.