Prescription medicine
Fostemsavir Brand names: Rukobia
Fostemsavir (Rukobia) is a prescription medicine with an FDA approval on record since 2020. No generic is listed; pharmacies paid $156.84 per Rukobia ER 600 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the fostemsavir FDA label on DailyMed (effective February 13, 2024, ViiV Healthcare Company); the NDA 212950 record on Drugs@FDA; every fostemsavir label on DailyMed.
Highlights of the record
FDA label of February 13, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageRUKOBIA, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations [see Clinical Studies ( 14 )].
Forms and strengths
- 600 mg
Film-coated extended-release tablet.
On the market
- Earliest approval on file
- July 2, 2020 Rukobia, Viiv Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- July 13, 2029 Rukobia tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $156.84 per tablet Rukobia ER 600 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 238 through July 30, 2026
What is fostemsavir used for?
From the label: indications and usageRUKOBIA, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations [see Clinical Studies ( 14 )]. […]
Conditions named in the indications of fostemsavir's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Rukobia), ViiV Healthcare Company, effective February 13, 2024 (SPL set a21006b7-6d6f-4f06-81b4-17978756452b), via openFDA; the full label on DailyMed
Is there a generic for fostemsavir (Rukobia)?
No generic fostemsavir is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Rukobia tablets: the compound patent runs to November 19, 2027, and the last listed entry to July 13, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fostemsavir (Rukobia)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $156.84 per Rukobia ER 600 mg tablet, up 5% from $149.98 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.
- Rukobia ER 600 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Rukobia ER 600 mg tablet | Brand | $156.84 per tablet | $4,705.09 | +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 fostemsavir label say about other medicines?
The fostemsavir label names 24 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name fostemsavir. 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 | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Atorvastatin | drug interactions | Concomitant Drug Class/Drug Name: Statins: Rosuvastatin b Atorvastatin Fluvastatin Pitavastatin Simvastatin; Effect on Concentration of Temsavir and/or Concomitant Drug: ↑Rosuvastatin ↑Atorvastatin ↑Fluvastatin ↑Pitavastatin ↑Simvastatin; … |
| Buprenorphine and naloxone | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Carbamazepine | contraindications | Enzalutamide o Anticonvulsants: Carbamazepine, phenytoin o Antimycobacterial: Rifampin o Antineoplastic: |
| Cobicistat | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Cobicistat and darunavir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Darunavir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Enzalutamide | contraindications | Enzalutamide o Anticonvulsants: Carbamazepine, phenytoin o Antimycobacterial: Rifampin o Antineoplastic: |
| Etravirine | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Famotidine | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Fluvastatin | drug interactions | Concomitant Drug Class/Drug Name: Statins: Rosuvastatin b Atorvastatin Fluvastatin Pitavastatin Simvastatin; Effect on Concentration of Temsavir and/or Concomitant Drug: ↑Rosuvastatin ↑Atorvastatin ↑Fluvastatin ↑Pitavastatin ↑Simvastatin; … |
| Maraviroc | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Methadone | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Mitotane | contraindications | Mitotane o Herbal product: St John’s wort ( Hypericum perforatum ) |
Every other medicine the fostemsavir label names
| Medicine named | Section | What the label says |
|---|---|---|
| Norethindrone | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Phenytoin | contraindications | Enzalutamide o Anticonvulsants: Carbamazepine, phenytoin o Antimycobacterial: Rifampin o Antineoplastic: |
| Pitavastatin | drug interactions | Concomitant Drug Class/Drug Name: Statins: Rosuvastatin b Atorvastatin Fluvastatin Pitavastatin Simvastatin; Effect on Concentration of Temsavir and/or Concomitant Drug: ↑Rosuvastatin ↑Atorvastatin … |
| Raltegravir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Rifabutin | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Rifampin | contraindications | Enzalutamide o Anticonvulsants: Carbamazepine, phenytoin o Antimycobacterial: Rifampin o Antineoplastic: |
| Ritonavir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Rosuvastatin | drug interactions | Concomitant Drug Class/Drug Name: Statins: Rosuvastatin b Atorvastatin Fluvastatin Pitavastatin Simvastatin; Effect on Concentration of Temsavir and/or Concomitant Drug: ↑Rosuvastatin ↑Atorvastatin … |
| Simvastatin | drug interactions | Concomitant Drug Class/Drug Name: Statins: Rosuvastatin b Atorvastatin Fluvastatin Pitavastatin Simvastatin; Effect on Concentration of Temsavir and/or Concomitant Drug: ↑Rosuvastatin ↑Atorvastatin … |
| Tenofovir disoproxil | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
Source: FDA drug label (Rukobia), ViiV Healthcare Company, effective February 13, 2024 (SPL set a21006b7-6d6f-4f06-81b4-17978756452b), via openFDA; the full label on DailyMed
What do FAERS reports show for fostemsavir?
The FDA Adverse Event Reporting System holds 238 reports that list fostemsavir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 19 are coded as a death and 23 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.
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 fostemsavir?
44 other medicines are given the same way (oral) and in the same FDA class as fostemsavir 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 |
| 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 |
| Maraviroc | HIV | 8 labelers | $9.15 per tablet 150 mg tablet | A presentation being discontinued |
| Atazanavir | HIV | 4 labelers | $2.23 per capsule 300 mg capsule | No current entry |
| Etravirine | HIV | 5 labelers | $9.94 per tablet 200 mg tablet | A presentation being discontinued |
| Abacavir | HIV | 12 labelers | $0.546 per tablet 300 mg tablet | No current entry |
Every medicine labeled for the same conditions as fostemsavir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to fostemsavir
- 44 medicines for the same use
- Fostemsavir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other