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

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

International Patents for HIVID

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

Country	Patent Number	Title	Estimated Expiration
Austria	96326
Australia	570855
Australia	6284386
Canada	1277915	INHIBITION DU POUVOIR INFECTANT IN VITRO ET DE L'EFFET CYTOPATHOGENE DU HTLV-III/LAV PAR LE 2'3'-DIDESOXYCYTIDINE (INHIBITION OF IN VITRO INFECTIVITY AND CYTOPATHIC EFFECT OF HTLV-III/LAV BY 2'3' -DIDEOXYCYTIDINE)
Germany	3689221

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

Last updated: February 3, 2026

What is the current market position of HIVID?

HIVID, also known as Hivid (zalcitabine), is an antiretroviral medication used primarily for the treatment of HIV/AIDS. Its market share has declined significantly due to the advent of newer therapies with improved efficacy and safety profiles. The drug is approved in multiple regions, including the U.S., Europe, and parts of Asia.

What is the regulatory status of HIVID?

HIVID received FDA approval in 1991 for use in combination therapy for HIV. Its regulatory status varies globally; in the U.S., it was designated as an orphan drug but has largely been phased out within the standard treatment regimens due to safety concerns and limited efficacy relative to current standards.

In 2013, the FDA removed HIVID from the list of approved drugs because of its declining clinical use. Similar status is observed in Europe and Japan, where it has not been actively marketed or approved for new patients.

How do HIVID’s pharmacological properties compare with current therapies?

HIVID is a nucleoside reverse transcriptase inhibitor (NRTI). It inhibits HIV replication by terminating DNA chain elongation. Key aspects:

• Efficacy: The drug has limited activity against HIV-1 compared to newer NRTIs like tenofovir or emtricitabine.
• Safety profile: High toxicity, including peripheral neuropathy and pancreatitis, restricts its use. It has a narrow therapeutic window.
• Pharmacokinetics: Poor bioavailability and rapid metabolism limit its dosing flexibility.

Newer drugs demonstrate superior efficacy, tolerability, and convenience. As a result, HIVID's role in current treatment is minimal.

What is the patent landscape relevant to HIVID?

HIVID was originally patented by Boehringer Ingelheim. The key patent expired around 2001 in the U.S. and Europe. The absence of recent patent protection means generic manufacturing is possible, reducing market exclusivity and price premiums.

No active patents or exclusivity periods are known to be in effect. The lack of patent protection diminishes potential revenues and discourages new R&D investments.

What does the competitive landscape look like?

The HIV/AIDS treatment market is crowded with first-line agents like:

• Tenofovir disoproxil fumarate (TDF)
• Emtricitabine
• Abacavir

These drugs outperform HIVID in safety, dosing, and efficacy. Fixed-dose combination pills, such as Triumeq and Biktarvy, dominate the market owing to convenience.

In older therapies like HIVID, market presence is limited to niche or salvage therapy cases where resistance renders newer drugs ineffective. Market share is negligible in most regions.

What are growth prospects and R&D trends for drugs like HIVID?

The trend favors development of integrase inhibitors (e.g., dolutegravir, bictegravir) and novel nucleoside analogs with improved profiles. Personalized medicine and resistance management also influence R&D priorities.

HIVID’s lifecycle has concluded: it is no longer being developed or marketed competitively. Future investments in similar drugs focus on maximizing safety, reducing pill burden, and managing resistance.

What should investors consider regarding HIVID?

• Depreciated patent value: Patent expiry in early 2000s diminishes potential returns.
• Market abandonment: Limited use and availability exclude it from current treatment guidelines.
• Regulatory absence: No recent approvals or filings.
• Generic competition: Widely available generics reduce profitability.
• Therapeutic obsolescence: Newer, safer, and more efficacious drugs have replaced HIVID.

Investors should view HIVID as a legacy product with minimal near-term value. R&D tends to focus on next-generation HIV therapies with novel mechanisms.

Key Takeaways

• HIVID's market role diminished after patent expiry and safety issues.
• Current HIV treatment guidelines favor more efficacious and safer drugs.
• Patent and regulatory status indicate no active development or commercialization.
• Competition from newer therapies renders HIVID obsolete in most markets.
• Investment in similar drugs requires focus on safety, efficacy, and resistance management.

FAQs

1. Is HIVID still prescribed for HIV treatment? No, it is rarely used in practice anymore because of safety concerns and inferior efficacy compared to current therapies.

2. Are there any ongoing clinical trials involving HIVID? No, there are no active clinical trials; the drug is considered obsolete.

3. Can HIVID’s patents be extended or reintroduced? No, the original patents have expired, and no new patents are in effect related to the drug.

4. What are the main safety concerns with HIVID? Peripheral neuropathy, pancreatitis, and other toxicities limit its use.

5. Are biosimilars or generics available for HIVID? Yes, due to patent expiration, generic versions are accessible in some markets.

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References:

[1] FDA Drug Database. "HIVID (zalcitabine): Drug Approval and Status," 2013.
[2] European Medicines Agency. "Hiv post-market surveillance reports," 2022.
[3] Boehringer Ingelheim. "Historical patent data and drug filings," Company Reports, 2000-2001.