Prescription medicine
Dolutegravir Brand names: Tivicay
Dolutegravir (Tivicay) is a prescription medicine with an FDA approval on record since 2013. No generic is listed; pharmacies paid $77.64 per Tivicay 50 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the dolutegravir FDA label on DailyMed (effective May 22, 2026, ST. MARY'S MEDICAL PARK PHARMACY); the NDA 204790 record on Drugs@FDA; every dolutegravir label on DailyMed.
Highlights of the record
FDA label of May 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg [see Microbiology ( 12.4 )].
Forms and strengths
- 5 mg
- 10 mg
- 25 mg
- 50 mg
Film-coated tablet; tablet for suspension.
On the market
- Earliest approval on file
- August 12, 2013 Tivicay, Viiv Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- June 8, 2030 Tivicay tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $77.64 per tablet Tivicay 50 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2014 0 Class I among all firms' recalls; latest May 17, 2024
What is dolutegravir used for?
From the label: indications and usageTIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg [see Microbiology ( 12.4 )]. […]
Conditions named in the indications of dolutegravir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor.
Source: FDA drug label (Tivicay), NDA204790 (Viiv Hlthcare), as published by ST. MARY'S MEDICAL PARK PHARMACY, effective May 22, 2026 (SPL set 485bc9db-8665-9f5a-e063-6394a90a7921), via openFDA; the full label on DailyMed
Is there a generic for dolutegravir (Tivicay)?
No generic dolutegravir is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 8 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 2 patents for Tivicay tablets: the compound patent runs to December 8, 2029 (pediatric exclusivity to June 8, 2030). A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dolutegravir (Tivicay)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $77.64 per Tivicay 50 mg tablet, up 3% from $75.35 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.
- Tivicay 50 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tivicay 50 mg tablet | Brand | $77.64 per tablet | $2,329.07 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dolutegravir been recalled?
The FDA's Enforcement Report lists 3 recalls naming dolutegravir since 2014: 0 Class I (the most serious), 0 Class II, 3 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 17, 2024 | Class III | GlaxoSmithKline LLC | Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet … |
| May 13, 2022 | Class III | GlaxoSmithKline LLC | Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January … |
| February 11, 2014 | Class III | Viiv Healthcare Company | Cross Contamination with Other Products: Product contains Promacta (eltrombopag). |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dolutegravir label say about other medicines?
The dolutegravir label names 25 other medicines in its interaction, contraindication or warning sections. The labels of 27 other medicines name dolutegravir. 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 |
|---|---|---|
| Atazanavir | drug interactions | Concomitant Drug Class/Drug Name: Non-nucleoside reverse transcriptase inhibitor: Etravirine a; Effect on Concentration of Dolutegravir and/or Concomitant Drug: ↓Dolutegravir; Clinical Comment: Use of TIVICAY or TIVICAY PD with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir, or … |
| Carbamazepine | drug interactions | Concomitant Drug Class/Drug Name: Carbamazepine a; Effect on Concentration of Dolutegravir and/or Concomitant Drug: ↓Dolutegravir; Clinical Comment: Adjust dose of TIVICAY to twice daily in treatment-naïve or treatment-experienced, INSTI-naïve adult patients. … |
| Dalfampridine | drug interactions | Dolutegravir may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 (dofetilide, dalfampridine, and metformin, Table 8 ) [see Contraindications ( 4 ), Drug Interactions ( 7.3 )]. |
| Darunavir | drug interactions | … Clinical Comment: Use of TIVICAY or TIVICAY PD with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir is not recommended. |
| Dofetilide | contraindications | CONTRAINDICATIONS TIVICAY and TIVICAY PD are contraindicated in patients: with previous hypersensitivity reaction to dolutegravir [see Warnings and Precautions ( 5.1 )]. receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events [see … |
| Efavirenz | drug interactions | Concomitant Drug Class/Drug Name: Non-nucleoside reverse transcriptase inhibitor: Efavirenz a; Effect on Concentration of Dolutegravir and/or Concomitant Drug: ↓Dolutegravir; Clinical Comment: Adjust dose of TIVICAY to twice daily for treatment-naïve and treatment-experienced, INSTI-naïve adult patients. … |
| Elbasvir and grazoprevir | drug interactions | Drugs without Clinically Significant Interactions with Dolutegravir Based on drug interaction trial results, the following drugs can be coadministered with dolutegravir without a dose adjustment: atazanavir/ritonavir, darunavir/ritonavir, elbasvir/grazoprevir, methadone, midazolam, omeprazole, oral contraceptives … |
| Etravirine | drug interactions | Concomitant Drug Class/Drug Name: Non-nucleoside reverse transcriptase inhibitor: Etravirine a; Effect on Concentration of Dolutegravir and/or Concomitant Drug: ↓Dolutegravir; Clinical Comment: Use of TIVICAY or TIVICAY PD with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir, or … |
| Fosamprenavir | drug interactions | Concomitant Drug Class/Drug Name: Protease inhibitors: Fosamprenavir/ritonavir a Tipranavir/ritonavir a; Effect on Concentration of Dolutegravir and/or Concomitant Drug: ↓Dolutegravir; Clinical Comment: Adjust dose of TIVICAY to twice daily for treatment-naïve and treatment-experienced, INSTI-naïve adult patients. … |
| Lopinavir and ritonavir | drug interactions | Etravirine significantly reduced plasma concentrations of dolutegravir, but the effect of etravirine was mitigated by coadministration of lopinavir/ritonavir or darunavir/ritonavir and is expected to be mitigated by atazanavir/ritonavir ( Table 8 ) [see Drug Interactions ( 7.3 ), Clinical Pharmacology ( 12.3 )]. |
| Metformin | drug interactions | Dolutegravir may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 (dofetilide, dalfampridine, and metformin, Table 8 ) [see Contraindications ( 4 ), Drug Interactions ( 7.3 )]. |
| Methadone | drug interactions | Drugs without Clinically Significant Interactions with Dolutegravir Based on drug interaction trial results, the following drugs can be coadministered with dolutegravir without a dose adjustment: atazanavir/ritonavir, darunavir/ritonavir, elbasvir/grazoprevir, methadone, midazolam, omeprazole, oral contraceptives … |
| Midazolam | drug interactions | … dolutegravir without a dose adjustment: atazanavir/ritonavir, darunavir/ritonavir, elbasvir/grazoprevir, methadone, midazolam, omeprazole, oral contraceptives containing norgestimate and ethinyl estradiol, prednisone, rifabutin, rilpivirine, sofosbuvir/velpatasvir, and tenofovir [see Clinical Pharmacology ( 12.3 )]. |
| Nevirapine | drug interactions | Concomitant Drug Class/Drug Name: Non-nucleoside reverse transcriptase inhibitor: Nevirapine; Effect on Concentration of Dolutegravir and/or Concomitant Drug: ↓Dolutegravir; Clinical Comment: Avoid coadministration with nevirapine because there are insufficient data to make dosing recommendations. |
Every other medicine the dolutegravir label names
| Medicine named | Section | What the label says |
|---|---|---|
| Omeprazole | drug interactions | … atazanavir/ritonavir, darunavir/ritonavir, elbasvir/grazoprevir, methadone, midazolam, omeprazole, oral contraceptives containing norgestimate and ethinyl estradiol, prednisone, rifabutin … |
| Oxcarbazepine | drug interactions | Concomitant Drug Class/Drug Name: Oxcarbazepine Phenytoin Phenobarbital St. John’s wort ( Hypericum perforatum); Effect on Concentration of Dolutegravir and/or Concomitant Drug: ↓Dolutegravir; … |
| Phenobarbital | drug interactions | Concomitant Drug Class/Drug Name: Oxcarbazepine Phenytoin Phenobarbital St. John’s wort ( Hypericum perforatum); Effect on Concentration of Dolutegravir and/or Concomitant Drug: ↓Dolutegravir; … |
| Phenytoin | drug interactions | Concomitant Drug Class/Drug Name: Oxcarbazepine Phenytoin Phenobarbital St. John’s wort ( Hypericum perforatum); Effect on Concentration of Dolutegravir and/or Concomitant Drug: ↓Dolutegravir; … |
| Prednisone | drug interactions | … oral contraceptives containing norgestimate and ethinyl estradiol, prednisone, rifabutin, rilpivirine, sofosbuvir/velpatasvir, and tenofovir [see Clinical Pharmacology ( 12.3 )]. |
| Rifabutin | drug interactions | … contraceptives containing norgestimate and ethinyl estradiol, prednisone, rifabutin, rilpivirine, sofosbuvir/velpatasvir, and tenofovir [see Clinical Pharmacology ( 12.3 )]. |
| Rifampin | drug interactions | Concomitant Drug Class/Drug Name: Rifampin a; Effect on Concentration of Dolutegravir and/or Concomitant Drug: ↓Dolutegravir; … |
| Rilpivirine | drug interactions | … containing norgestimate and ethinyl estradiol, prednisone, rifabutin, rilpivirine, sofosbuvir/velpatasvir, and tenofovir [see Clinical Pharmacology ( 12.3 )]. |
| Ritonavir | drug interactions | … TIVICAY PD with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir is not recommended. |
| Sofosbuvir and velpatasvir | drug interactions | Drugs without Clinically Significant Interactions with Dolutegravir Based on drug interaction trial results, the following drugs can be coadministered with dolutegravir without a dose adjustment … |
| Sucralfate | drug interactions | Concomitant Drug Class/Drug Name: Medications containing polyvalent cations (e.g., Mg or Al): Cation-containing antacids a or laxatives Sucralfate Buffered medications; … |
Source: FDA drug label (Tivicay), NDA204790 (Viiv Hlthcare), as published by ST. MARY'S MEDICAL PARK PHARMACY, effective May 22, 2026 (SPL set 485bc9db-8665-9f5a-e063-6394a90a7921), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as dolutegravir?
41 other medicines are given the same way (oral) and in the same FDA class as dolutegravir 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 |
|---|---|---|---|---|
| Raltegravir | HIV | 1 labeler | $34.54 per tablet 400 mg tablet | No current entry |
| Cabotegravir | HIV | none listed | n/a | No current entry |
| Cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide | HIV | none listed | $143.35 per tablet Genvoya tablet | No current entry |
| Cobicistat, elvitegravir, emtricitabine and tenofovir disoproxil | HIV | none listed | $150.14 per tablet Stribild tablet | No current entry |
| Emtricitabine and tenofovir disoproxil | HIV | 25 labelers | $0.529 per tablet 200-300 mg tablet | No current entry |
| Darunavir | HIV | 13 labelers | $1.16 per tablet 600 mg tablet | No current entry |
| Lamivudine | HIV | 14 labelers | $0.489 per tablet 150 mg tablet | No current entry |
| Tenofovir disoproxil | HIV | 15 labelers | $0.294 per tablet 300 mg tablet | No current entry |
Every medicine labeled for the same conditions as dolutegravir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to dolutegravir
- 41 medicines for the same use
- Other human immunodeficiency virus integrase strand transfer inhibitors
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other