Prescription medicine
Dolutegravir and lamivudine Brand names: Dovato
Dolutegravir and lamivudine (Dovato) is a prescription medicine with an FDA approval on record since 2019. No generic is listed; pharmacies paid $105.22 per Dovato 50-300 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the dolutegravir and lamivudine FDA label on DailyMed (effective October 29, 2025, ViiV Healthcare Company); the NDA 211994 record on Drugs@FDA; every dolutegravir and lamivudine label on DailyMed.
Highlights of the record
FDA label of October 29, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV.
All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment [see Warnings and Precautions ( 5.1 )]. WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV See full prescribing information for complete boxed warning.
All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. […]
Used for
From the label: indications and usageDOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitut
Forms and strengths
- 50 mg / 300 mg
Film-coated tablet.
On the market
- Earliest approval on file
- April 8, 2019 Dovato, Viiv Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 24, 2031 Dovato tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $105.22 per tablet Dovato 50-300 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,529 through July 30, 2026
What is dolutegravir and lamivudine used for?
From the label: indications and usageDOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO. […]
Conditions named in the indications of dolutegravir and lamivudine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (Dovato), ViiV Healthcare Company, effective October 29, 2025 (SPL set 68e45422-43ed-4cfb-9356-fae88d14a53a), via openFDA; the full label on DailyMed
What does the patient leaflet for dolutegravir and lamivudine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DOVATO?If you have both human immunodeficiency virus-1 (HIV-1) infection and Hepatitis B virus (HBV) infection, DOVATO can cause serious side effects, including: • Resistant HBV. Your healthcare provider will test you for HBV infection before you start treatment with DOVATO. If you have HIV-1 and hepatitis B, the HBV can change (mutate) during your treatment with DOVATO and become harder to treat (resistant). It is not known if DOVATO is safe and effective in people who have HIV-1 and HBV infection. • Worsening of HBV infection. If you have HBV infection and take DOVATO, your HBV may get worse (flare-up) if you stop taking DOVATO. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. o Do not run out of DOVATO. Refill your prescription or talk to your healthcare provider before your DOVATO is all gone. o Do not stop DOVATO without first talking to your healthcare provider. o If you stop taking DOVATO, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver function and monitor your HBV infection. It may be necessary to give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking DOVATO. For more information about side effects, see “What are the possible side effects of DOVATO?”
From the patient leaflet: How should I store DOVATO?Store DOVATO below 86°F (30°C). • DOVATO comes in a child-resistant package. Keep DOVATO and all medicines out of the reach of children.
Source: FDA drug label (Dovato), ViiV Healthcare Company, effective October 29, 2025 (SPL set 68e45422-43ed-4cfb-9356-fae88d14a53a), via openFDA; the full label on DailyMed
Is there a generic for dolutegravir and lamivudine (Dovato)?
No generic dolutegravir and lamivudine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Dovato tablets: the compound patent runs to December 8, 2029 (pediatric exclusivity to June 8, 2030), and the last listed entry to January 24, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dolutegravir and lamivudine (Dovato)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $105.22 per Dovato 50-300 mg tablet, up 5% from $99.96 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Dovato 50-300 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dovato 50-300 mg tablet | Brand | $105.22 per tablet | $3,156.74 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the dolutegravir and lamivudine label say about other medicines?
The dolutegravir and lamivudine label names 9 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Coadministered Drug Class/Drug Name: Anticonvulsant: Carbamazepine a; Effect on Concentration: ↓Dolutegravir; Clinical Comment: An additional dolutegravir 50-mg dose should be taken, separated by 12 hours from DOVATO [see Dosage and Administration ()]. |
| Dalfampridine | drug interactions | Coadministered Drug Class/Drug Name: Potassium channel blocker: Dalfampridine; Effect on Concentration: ↑Dalfampridine; Clinical Comment: Elevated levels of dalfampridine increase the risk of seizures. … |
| Dofetilide | contraindications | • receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events [see Drug Interactions ( 7.2 )]. |
| Metformin | drug interactions | Coadministered Drug Class/Drug Name: Antidiabetic: Metformin a; Effect on Concentration: ↑Metformin; Clinical Comment: Refer to the prescribing information for metformin for assessing the benefit and risk of concomitant use of DOVATO and metformin. |
| Oxcarbazepine | drug interactions | Coadministered Drug Class/Drug Name: Anticonvulsants: Oxcarbazepine Phenytoin Phenobarbital; Effect on Concentration: ↓Dolutegravir; Clinical Comment: Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations. |
| Phenobarbital | drug interactions | Coadministered Drug Class/Drug Name: Anticonvulsants: Oxcarbazepine Phenytoin Phenobarbital; Effect on Concentration: ↓Dolutegravir; Clinical Comment: Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations. |
| Phenytoin | drug interactions | Coadministered Drug Class/Drug Name: Anticonvulsants: Oxcarbazepine Phenytoin Phenobarbital; Effect on Concentration: ↓Dolutegravir; Clinical Comment: Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations. |
| Rifampin | drug interactions | Coadministered Drug Class/Drug Name: Antimycobacterial: Rifampin a; Effect on Concentration: ↓Dolutegravir; Clinical Comment: An additional 50-mg dose of dolutegravir should be taken, separated by 12 hours from DOVATO [see Dosage and Administration ()]. |
| Sucralfate | drug interactions | Coadministered Drug Class/Drug Name: Medications containing polyvalent cations (e.g., Mg or Al): Cation-containing antacids a or laxatives Sucralfate Buffered medications; Effect on Concentration: ↓Dolutegravir; … |
Source: FDA drug label (Dovato), ViiV Healthcare Company, effective October 29, 2025 (SPL set 68e45422-43ed-4cfb-9356-fae88d14a53a), via openFDA; the full label on DailyMed
What do FAERS reports show for dolutegravir and lamivudine?
The FDA Adverse Event Reporting System holds 3,529 reports that list dolutegravir and lamivudine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 118 are coded as a death and 415 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dolutegravir and lamivudine?
34 other medicines are given the same way (oral) and in the same FDA class as dolutegravir and lamivudine or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Emtricitabine and tenofovir disoproxil | HIV | 25 labelers | $0.529 per tablet 200-300 mg tablet | No current entry |
| Tenofovir disoproxil | HIV | 15 labelers | $0.294 per tablet 300 mg tablet | No current entry |
| Abacavir | HIV | 12 labelers | $0.546 per tablet 300 mg tablet | No current entry |
| Raltegravir | HIV | 1 labeler | $34.54 per tablet 400 mg tablet | No current entry |
| Efavirenz and emtricitabine and tenofovir disoproxil | HIV | 7 labelers | $1.12 per tablet 600-200-300 mg tablet | No current entry |
| Zidovudine | HIV | 3 labelers | $0.464 per tablet 300 mg tablet | No current entry |
| Bictegravir and emtricitabine and tenofovir alafenamide | HIV | none listed | $136.73 per tablet 50-200-25 mg tablet | No current entry |
| Emtricitabine | HIV | 2 labelers | $12.69 per capsule 200 mg capsule | A presentation being discontinued |
Every medicine labeled for the same conditions as dolutegravir and lamivudine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does dolutegravir and lamivudine compare with medicines for the same use?
1 side-by-side page set dolutegravir and lamivudine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to dolutegravir and lamivudine
- 34 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Dolutegravir and lamivudine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other