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Molecule

Nelfinavir

Also known as nelfinavir mesylate
Available on requestHIV
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Nelfinavir is a protease inhibitor indicated for the treatment of HIV-1 infection. It is available as tablets for oral use. MedsAcross supplies Nelfinavir for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Protease Inhibitor, Cytochrome P450 3A Inhibitors, HIV Protease Inhibitors
ATC classification
J05AE04 Nelfinavir · Direct acting antiviral, subgroup J05AE
US FDA first approval
14 March 1997
EU status
Withdrawn
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII HO3OGH5D7IRxCUI 134527CAS 159989-64-7DrugBank DB00220Q423366

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

VIRACEPT in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. VIRACEPT is a protease inhibitor indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.

Source: US FDA prescribing information

Dosing overview

• See full prescribing information for administration instructions. • Adults and adolescents 13 years and older (tablets): 1250 mg twice daily or 750 mg three times daily with a meal. • Children 2 to less than 13 years (oral powder or 250 mg tablets): 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily with a meal. Refer to Tables 1 and 2 of the full prescribing information for specific dosing guidelines based on age and body weight

Source: US FDA prescribing information

Contraindications

Coadministration of VIRACEPT is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These drugs and other contraindicated drugs (which may lead to reduced efficacy of nelfinavir) are listed in Table 3 [also see Drug Interactions, Table 6 ]. Table 3: Drugs That Are Contraindicated With VIRACEPT Drug Class Drugs Within Class That Are Contraindicated With VIRACEPT Clinical Comment Alpha 1-adrenoreceptor antagonist Alfuzosin Potentially increased alfuzosin concentrations can result in hypotension.

Source: US FDA prescribing information

Warnings and precautions

ALERT: Find out about medicines that should not be taken with VIRACEPT. This statement is included on the product's bottle label. ALERT: Find out about medicines that should not be taken with VIRACEPT. • The concomitant use of VIRACEPT and certain other drugs may result in known or potentially significant drug interactions. Consult the full prescribing information prior to and during treatment for potential drug interactions. • Hepatic impairment: should not be used in patients with either moderate or severe hepatic impairment. • Phenylketonuria: the oral powder contains 11.2 mg phenylalanine per gram of powder. • Diabetes mellitus/hyperglycemia: new onset or exacerbation of pre-existing diabetes mellitus and hyperglycemia reported with protease inhibitors. In some cases after treatment discontinuation, hyperglycemia persisted.

Source: US FDA prescribing information

Side effects

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. • Most common adverse reactions (≥2%) of moderate or severe intensity in adults and adolescents (13 years and older) are diarrhea, nausea, rash, and flatulence. • Most common adverse reactions in pediatric patients (2 to less than 13 years) are diarrhea, leukopenia/neutropenia, rash, anorexia, and abdominal pain.

Source: US FDA prescribing information

Interactions

• Coadministration of VIRACEPT with other drugs ( CYP3A substrates) can alter the concentration of these other drugs, and other drugs (inhibitors and/or inducers of CYP3A or CYP2C19) may alter the concentrations of nelfinavir. The potential drug-drug concentrations must be considered prior to and during therapy. • VIRACEPT should be given with food one hour after or more than 2 hours before didanosine

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Nelfinavir, sorted by availability.

MedicineManufacturerRegisterAvailability
Viracept 250 mg tabletOralAgouronUS FDAAvailable on request
Viracept 625 mg tabletOralAgouronUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 14 March 1997Drugs@FDA
EU (EMA)WithdrawnEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Nelfinavir in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Nelfinavir available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Nelfinavir and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Nelfinavir have?

The catalogue lists 1 brand names for Nelfinavir, including Viracept.

Is Nelfinavir approved by the US FDA?

Yes. The US FDA first approved Nelfinavir on 14 March 1997, according to Drugs@FDA.

Does Nelfinavir need cold chain shipping?

No listed presentation of Nelfinavir is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Nelfinavir in?

Nelfinavir is classified under ATC code J05AE04 (Nelfinavir).

References

  1. VIRACEPT prescribing information (Agouron). U.S. National Library of Medicine, DailyMed. Retrieved 11 December 2025

Request Nelfinavir for export supply

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