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Abacavir | CAS No: 136470-78-5 | GMP-certified suppliers
A medication that supports combination therapy for HIV‑1 infection in adults and children, helping manufacturers supply reliable antiviral options across major regulated markets.
Therapeutic categories
Anti-HIV AgentsAnti-Infective AgentsAnti-Retroviral AgentsAntiinfectives for Systemic UseAntiviral AgentsAntivirals for Systemic Use
Generic name
Abacavir
Molecule type
small molecule
CAS number
136470-78-5
DrugBank ID
DB01048
Approval status
Approved drug, Investigational drug
ATC code
J05AR13
Primary indications
- Abacavir is indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection
- It is available in a combination product alongside [dolutegravir] and [lamivudine] for the treatment of adult and pediatric patients with HIV-1 who weigh ≥10 kg
Product Snapshot
- Oral small‑molecule API supplied mainly in tablet and solution formulations
- Used in combination antiretroviral regimens for HIV‑1 infection
- Approved in major markets including the US, Canada, and the EU
Clinical Overview
Abacavir (CAS 136470-78-5) is a synthetic carbocyclic nucleoside analogue classified among 1,3‑substituted cyclopentyl purine nucleosides. It is indicated, in combination with other antiretroviral agents, for the treatment of HIV‑1 infection in adults and children. Fixed‑dose combinations containing abacavir with dolutegravir and lamivudine are widely used in patients weighing at least 10 kg.
Abacavir functions as a nucleoside reverse transcriptase inhibitor. After cellular uptake, it undergoes sequential phosphorylation to form carbovir triphosphate, an analogue of deoxyguanosine triphosphate. This active metabolite competes with the endogenous substrate for incorporation into nascent viral DNA. Once incorporated, it terminates chain elongation due to the absence of a 3‑hydroxyl group. In cell‑based assays, abacavir demonstrates EC50 values of approximately 3.7 to 5.8 micromolar against HIV‑1IIIB and 0.07 to 1.0 micromolar against HIV‑1BaL, with an average EC50 of 0.26 micromolar across clinical isolates. Synergistic activity has been observed with zidovudine, nevirapine, and amprenavir, with additive effects reported with several other nucleoside analogues.
Following oral administration, abacavir sulfate rapidly dissociates to release the free base. It is well absorbed and widely distributed intracellularly, where active metabolite formation occurs. Metabolism proceeds primarily through alcohol dehydrogenase and glucuronidation pathways, with renal excretion of metabolites. Abacavir is not primarily cleared unchanged in urine.
Safety considerations include the risk of serious hypersensitivity reactions, which are strongly associated with the HLA‑B*57:01 allele. Severe reactions require permanent discontinuation. Other toxicities include potential hepatic effects and the general mitochondrial toxicity risks shared by nucleoside analogues.
Common usage contexts include individual formulations and fixed‑dose combinations such as abacavir plus dolutegravir and lamivudine.
For API procurement, emphasis should be placed on genomic‑risk‑related labeling compliance, impurity control specific to carbocyclic nucleosides, and reliable documentation of stereochemical integrity and process consistency.
Abacavir functions as a nucleoside reverse transcriptase inhibitor. After cellular uptake, it undergoes sequential phosphorylation to form carbovir triphosphate, an analogue of deoxyguanosine triphosphate. This active metabolite competes with the endogenous substrate for incorporation into nascent viral DNA. Once incorporated, it terminates chain elongation due to the absence of a 3‑hydroxyl group. In cell‑based assays, abacavir demonstrates EC50 values of approximately 3.7 to 5.8 micromolar against HIV‑1IIIB and 0.07 to 1.0 micromolar against HIV‑1BaL, with an average EC50 of 0.26 micromolar across clinical isolates. Synergistic activity has been observed with zidovudine, nevirapine, and amprenavir, with additive effects reported with several other nucleoside analogues.
Following oral administration, abacavir sulfate rapidly dissociates to release the free base. It is well absorbed and widely distributed intracellularly, where active metabolite formation occurs. Metabolism proceeds primarily through alcohol dehydrogenase and glucuronidation pathways, with renal excretion of metabolites. Abacavir is not primarily cleared unchanged in urine.
Safety considerations include the risk of serious hypersensitivity reactions, which are strongly associated with the HLA‑B*57:01 allele. Severe reactions require permanent discontinuation. Other toxicities include potential hepatic effects and the general mitochondrial toxicity risks shared by nucleoside analogues.
Common usage contexts include individual formulations and fixed‑dose combinations such as abacavir plus dolutegravir and lamivudine.
For API procurement, emphasis should be placed on genomic‑risk‑related labeling compliance, impurity control specific to carbocyclic nucleosides, and reliable documentation of stereochemical integrity and process consistency.
Identification & chemistry
| Generic name | Abacavir |
|---|---|
| Molecule type | Small molecule |
| CAS | 136470-78-5 |
| UNII | WR2TIP26VS |
| DrugBank ID | DB01048 |
Pharmacology
| Summary | Abacavir is a nucleoside reverse transcriptase inhibitor that is intracellularly converted to carbovir triphosphate, an analogue of deoxyguanosine triphosphate. The active metabolite competitively inhibits HIV‑1 reverse transcriptase and terminates viral DNA chain elongation. Its pharmacology reflects targeted suppression of HIV‑1 replication through impaired nucleotide incorporation. |
|---|---|
| Mechanism of action | Abacavir is a carbocyclic synthetic nucleoside analogue and an antiviral agent. Intracellularly, abacavir is converted by cellular enzymes to the active metabolite carbovir triphosphate, an analogue of deoxyguanosine-5'-triphosphate (dGTP). Carbovir triphosphate inhibits the activity of HIV-1 reverse transcriptase (RT) both by competing with the natural substrate dGTP and by its incorporation into viral DNA. Viral DNA growth is terminated because the incorporated nucleotide lacks a 3'-OH group, which is needed to form the 5′ to 3′ phosphodiester linkage essential for DNA chain elongation. |
| Pharmacodynamics | Abacavir is a nucleoside reverse transcriptase inhibitor (NRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Abacavir is phosphorylated to active metabolites that compete for incorporation into viral DNA. They inhibit the HIV reverse transcriptase enzyme competitively and act as a chain terminator of DNA synthesis. The concentration of drug necessary to effect viral replication by 50 percent (EC50) ranged from 3.7 to 5.8 μM (1 μM = 0.28 mcg/mL) and 0.07 to 1.0 μM against HIV-1IIIB and HIV-1BaL, respectively, and was 0.26 ± 0.18 μM against 8 clinical isolates. Abacavir had synergistic activity in cell culture in combination with the nucleoside reverse transcriptase inhibitor (NRTI) zidovudine, the non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine, and the protease inhibitor (PI) amprenavir; and additive activity in combination with the NRTIs didanosine, emtricitabine, lamivudine, stavudine, tenofovir, and zalcitabine. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Reverse transcriptase/RNaseH | Human immunodeficiency virus 1 | inhibitor |
| HLA class I histocompatibility antigen, B-57 alpha chain | Humans |
ADME / PK
| Absorption | Rapid and extensive after oral administration (83% bioavailability, tablet). When a 300 mg tablet is given twice daily to subjects, the peak plasma concentration (Cmax) was 3.0 ± 0.89 mcg/mL and the area under the curve (AUC 0-12 hours) was 6.02 ± 1.73 mcg•hr/mL. |
|---|---|
| Half-life | 1.54 ± 0.63 hours |
| Protein binding | Moderate (approximately 50%). Binding of abacavir to plasma protein was independent of concentration. |
| Metabolism | Hepatic, by alcohol dehydrogenase and glucuronosyltransferase to a 5′-carboxylic acid metabolite and 5′-glucuronide metabolite, respectively. These metabolites have no antiviral activity. Abacavir is not significantly metabolized by cytochrome P450 enzymes. |
| Route of elimination | Elimination of abacavir was quantified in a mass balance study following administration of a 600-mg dose of 14C-abacavir: 99% of the radioactivity was recovered, 1.2% was excreted in the urine as abacavir, 30% as the 5′-carboxylic acid metabolite, 36% as the 5′-glucuronide metabolite, and 15% as unidentified minor metabolites in the urine. Fecal elimination accounted for 16% of the dose. Renal excretion of unchanged abacavir is a minor route of elimination in humans. |
| Volume of distribution | * 0.86 ± 0.15 L/kg [IV administration] |
| Clearance | * 0.80 ± 0.24 L/hr/kg [asymptomatic, HIV-1-infected adult patients receiving single (IV dose of 150 mg] |
Formulation & handling
- Oral small‑molecule nucleoside analogue suitable for solid and liquid formulations with no significant food‑related absorption effects.
- High aqueous solubility and low logP support conventional oral tablet and solution processing without specialized solubilization strategies.
- Handle as a chemically stable solid, with consideration for avoiding alcohol-containing excipients due to increased systemic exposure.
Regulatory status
| Lifecycle | Patent protection for the API has largely lapsed in Canada and for older U.S. patents, while a later‑expiring U.S. patent extends some exclusivity until 2030. With products marketed in the US, Canada, and the EU, the API is generally in a mature market phase except where the remaining U.S. patent may still limit full generic entry. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Abacavir is supplied by multiple packagers, with the originator group represented by ViiV Healthcare/GlaxoSmithKline alongside several secondary repackagers that support distribution in the US and Canada. Branded and authorized products are present across the US, EU, and Canadian markets, indicating a mature global footprint. Most historical patents have expired in the US and Canada, and although one US patent extends to 2030, the overall landscape reflects established or emerging generic participation depending on jurisdiction and formulation. |
|---|
Safety
| Toxicity | Some myocardial degeneration has been noticed in rats and mice. The most commonly reported adverse reactions of at least moderate intensity (incidence ≥10%) in adult HIV-1 clinical trials were nausea, headache, malaise and fatigue, nausea and vomiting, and dreams/sleep disorders. Serious hypersensitivity reactions have been associated with abacavir which has been strongly linked to the presence of the HLA-B*57:01 allele. This reaction manifests itself in patients within the first 6 weeks of treatment. Patients should be tested for the presence of this allele as recommended by the U.S Food and Drug Administration (FDA). |
|---|
High Level Warnings:
- Associated with serious hypersensitivity reactions linked to the HLA‑B*57:01 allele
- Reactions can present early in exposure and require controlled handling protocols to prevent inappropriate use
- Reports of myocardial degeneration in rodent studies indicate a need for caution in preclinical safety assessments and storage/handling to avoid unintended exposure
Abacavir Sulfate is a type of Anti-HIV
The Anti-HIV category of pharmaceutical APIs comprises a range of active pharmaceutical ingredients (APIs) specifically designed to combat the human immunodeficiency virus (HIV). These APIs play a critical role in the development and production of antiretroviral drugs, which are used to treat HIV infections and prevent the progression to acquired immunodeficiency syndrome (AIDS).
Anti-HIV APIs work by targeting various stages of the HIV life cycle, inhibiting viral replication and reducing the viral load in the body. Some commonly used APIs in this category include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), and integrase inhibitors (INIs).
NRTIs, such as tenofovir and emtricitabine, act by blocking the reverse transcriptase enzyme, an essential component in the replication of the virus. NNRTIs, such as efavirenz and nevirapine, bind to the reverse transcriptase enzyme, preventing its proper functioning. PIs, like ritonavir and atazanavir, inhibit the protease enzyme, crucial for viral maturation and assembly. INIs, such as raltegravir and dolutegravir, target the integrase enzyme, impeding viral integration into the host's DNA.
These APIs are carefully synthesized and undergo rigorous quality testing to ensure their safety, efficacy, and compliance with regulatory standards. Pharmaceutical companies utilize these APIs as key building blocks to formulate antiretroviral medications, which are then prescribed to individuals living with HIV/AIDS worldwide.
Overall, the Anti-HIV API category plays a vital role in the ongoing battle against HIV/AIDS, offering effective treatment options and improved quality of life for patients affected by this challenging condition.
Abacavir Sulfate API manufacturers & distributors
Compare qualified Abacavir Sulfate API suppliers worldwide. We currently have 15 companies offering Abacavir Sulfate API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Cipla | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 164 products |
| Divis Labs. | Producer | India | India | CoA, GMP | 47 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hetero Labs | Producer | India | India | CoA, GMP, USDMF, WC | 90 products |
| Jiangxi Bioman Pharma Lim... | Producer | China | China | CoA | 15 products |
| Laurus Labs | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 50 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 155 products |
| Mylan | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 201 products |
| Piramal Healthcare | Producer | United Kingdom | India | CoA, GMP, WC | 31 products |
| Shanghai Acebright | Producer | China | China | CoA | 23 products |
| Shilpa Medicare Ltd | Producer | India | India | CoA, FDA, GMP, ISO9001 | 54 products |
| Signa | Producer | Mexico | Mexico | CoA, USDMF | 42 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 764 products |
When sending a request, specify which Abacavir Sulfate API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Abacavir Sulfate API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Abacavir Sulfate API
Sourcing
What matters most when sourcing GMP-grade Abacavir Sulfate?
Key considerations include confirming GMP compliance and ensuring the material aligns with regulatory expectations in the US, Canada, and the EU. It is also important to verify the supplier’s authorization status, given the presence of both originator (ViiV Healthcare/GSK) and secondary repackagers in these markets. Finally, patent status should be reviewed by jurisdiction, as most have expired but one US patent remains active until 2030.
Which documents are typically required when sourcing Abacavir Sulfate API?
Request the core API documentation set: CoA (15 companies), GMP (11 companies), USDMF (8 companies), CEP (6 companies), WC (6 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Abacavir Sulfate API?
Known or reported manufacturers for Abacavir Sulfate: Sinoway industrial Co.,Ltd, LGM Pharma, Shilpa Medicare Ltd, Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Abacavir Sulfate API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Abacavir Sulfate manufacturers?
Audit reports may be requested for Abacavir Sulfate: 7 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Abacavir Sulfate API on Pharmaoffer?
Reported supplier count for Abacavir Sulfate: 15 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Abacavir Sulfate API?
Production countries reported for Abacavir Sulfate: India (9 producers), China (3 producers), Mexico (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Abacavir Sulfate usually hold?
Common certifications for Abacavir Sulfate suppliers: CoA (15 companies), GMP (11 companies), USDMF (8 companies), CEP (6 companies), WC (6 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Abacavir Sulfate (CAS 136470-78-5) used for?
Abacavir Sulfate is used, in combination with other antiretroviral agents, for the treatment of HIV‑1 infection in adults and children. It acts as a nucleoside reverse transcriptase inhibitor, forming carbovir triphosphate intracellularly to block viral DNA chain elongation. Fixed‑dose combinations containing Abacavir Sulfate, such as those with dolutegravir and lamivudine, are commonly used in patients weighing at least 10 kg.
Which therapeutic class does Abacavir Sulfate fall into?
Abacavir Sulfate belongs to the following therapeutic categories: Anti-HIV Agents, Anti-Infective Agents, Anti-Retroviral Agents, Antiinfectives for Systemic Use, Antiviral Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Abacavir Sulfate mainly prescribed for?
The primary indications for Abacavir Sulfate: Abacavir Sulfate is indicated in combination with other anti-retroviral agents for the treatment of HIV-1 infection, It is available in a combination product alongside [dolutegravir] and [lamivudine] for the treatment of adult and pediatric patients with HIV-1 who weigh ≥10 kg. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Abacavir Sulfate work?
Abacavir Sulfate is a carbocyclic synthetic nucleoside analogue and an antiviral agent. Intracellularly, Abacavir Sulfate is converted by cellular enzymes to the active metabolite carbovir triphosphate, an analogue of deoxyguanosine-5'-triphosphate (dGTP). Carbovir triphosphate inhibits the activity of HIV-1 reverse transcriptase (RT) both by competing with the natural substrate dGTP and by its incorporation into viral DNA. Viral DNA growth is terminated because the incorporated nucleotide lacks a 3'-OH group, which is needed to form the 5′ to 3′ phosphodiester linkage essential for DNA chain elongation.
What should someone know about the safety or toxicity profile of Abacavir Sulfate?
Abacavir Sulfate can cause serious hypersensitivity reactions strongly linked to the HLA‑B*57:01 allele, and exposure should be avoided in individuals who test positive for this genotype. Reactions typically occur early in therapy and require permanent discontinuation if they develop. Other noted toxicities include potential hepatic effects and mitochondrial toxicity associated with nucleoside analogues. Rodent findings of myocardial degeneration highlight the need for controlled handling and careful preclinical safety evaluation.
What are important formulation and handling considerations for Abacavir Sulfate as an API?
Abacavir Sulfate’s high aqueous solubility and low logP allow straightforward processing into tablets or oral solutions without the need for specialized solubilization approaches. It is handled as a chemically stable solid, but formulations should avoid alcohol‑containing excipients because hepatic alcohol dehydrogenase metabolism can increase systemic exposure. Its absorption is not meaningfully affected by food, supporting conventional oral dosing formats. Standard precautions for small‑molecule APIs apply to limit exposure and maintain material integrity during manufacture.
Is Abacavir Sulfate a small molecule?
Abacavir Sulfate is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Abacavir Sulfate?
Abacavir Sulfate is a chemically stable solid and generally does not require special stabilization measures in oral formulations. Its high aqueous solubility supports conventional tablet and solution manufacturing. The main consideration is avoiding alcohol‑containing excipients, which can increase systemic exposure. No food‑related effects on stability or absorption are noted.
Regulatory
Where is Abacavir Sulfate approved or in use globally?
Abacavir Sulfate is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Abacavir Sulfate procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Abacavir Sulfate. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Abacavir Sulfate included in the PRO Data Insights coverage?
PRO Data Insights coverage for Abacavir Sulfate: 336 verified transactions across 113 suppliers and 70 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Abacavir Sulfate?
Market report availability for Abacavir Sulfate: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
