Prescription medicine
Lenacapavir Brand names: Sunlenca, Yeztugo
Lenacapavir (Yeztugo) is a prescription medicine with an FDA approval on record since 2022. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the lenacapavir FDA label on DailyMed (effective August 27, 2026, Gilead Sciences, Inc.); the NDA 215973 record on Drugs@FDA; every lenacapavir label on DailyMed.
Highlights of the record
FDA label of August 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSUNLENCA, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, is indicated: in combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 whose current antiretroviral regimen is failing due to resistance, intolerance, or safety considerations.
Forms and strengths
- 300 mg
Kit; film-coated tablet.
On the market
- Earliest approval on file
- December 22, 2022 Sunlenca, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- November 25, 2040 Yeztugo injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 462 through July 30, 2026
What is lenacapavir used for?
From the label: indications and usageSUNLENCA, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, is indicated: in combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 whose current antiretroviral regimen is failing due to resistance, intolerance, or safety considerations. […]
Conditions named in the indications of lenacapavir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Human Immunodeficiency Virus 1 Capsid Inhibitor.
Source: FDA drug label (Sunlenca), Gilead Sciences, Inc., effective August 27, 2026 (SPL set e5652804-29c4-40d7-aeb2-0142ed2a7b5b), via openFDA; the full label on DailyMed
Is there a generic for lenacapavir (Yeztugo)?
No generic lenacapavir is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Yeztugo injection: the compound patent runs to August 16, 2038, and the last listed entry to November 25, 2040; a patent listed only for Sunlenca tablets runs to August 28, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2022 earliest approval on file
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the lenacapavir label say about other medicines?
The lenacapavir label names 43 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name lenacapavir. 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: Antiretroviral Agents: atazanavir/cobicistat Drug-drug interaction study was conducted. atazanavir/ritonavir; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ lenacapavir (atazanavir/cobicistat, atazanavir/ritonavir); … |
| Atazanavir and cobicistat | 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 | Drugs without Clinically Significant Interactions with YEZTUGO Based on drug interaction studies conducted with YEZTUGO, no clinically significant drug interactions have been observed with: atorvastatin, famotidine, pitavastatin, rosuvastatin, tenofovir alafenamide, and voriconazole. |
| Buprenorphine | drug interactions | Initiation of SUNLENCA in patients taking buprenorphine or methadone: A dose adjustment for buprenorphine or methadone may be needed. Monitor clinical signs and symptoms. |
| Carbamazepine | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↓ lenacapavir; Clinical Comment: Concomitant administration of carbamazepine, oxcarbazepine, phenobarbital, or phenytoin may result in loss of therapeutic effect … |
| Cobicistat | drug interactions | Concomitant Drug Class/Drug Name: Antiretroviral Agents: atazanavir/cobicistat Drug-drug interaction study was conducted. atazanavir/ritonavir; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ lenacapavir (atazanavir/cobicistat, atazanavir/ritonavir); … |
| Cobicistat and darunavir | drug interactions | Sedatives/Hypnotics: midazolam (oral) triazolam ↑ midazolam (oral) ↑ triazolam Use with caution when midazolam or triazolam is concomitantly administered with SUNLENCA 7.4 Drugs without Clinically Significant Interactions with SUNLENCA Based on drug interaction studies conducted with SUNLENCA, no clinically … |
| Cortisone | drug interactions | Concomitant Drug Class/Drug Name: Corticosteroids (systemic): cortisone/hydrocortisone dexamethasone; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ corticosteroids (systemic); Clinical Comment: Concomitant administration with systemic corticosteroids whose exposures are significantly increased by CYP3A … |
| Dabigatran | drug interactions | Concomitant Drug Class/Drug Name: Anticoagulants: Direct Oral Anticoagulants (DOACs) rivaroxaban dabigatran edoxaban; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ DOAC; Clinical Comment: Refer to the DOAC prescribing information for concomitant administration with moderate CYP3A inhibitors and/or P-gp … |
| Dexamethasone | drug interactions | Concomitant Drug Class/Drug Name: Corticosteroids (systemic): cortisone/hydrocortisone dexamethasone; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ corticosteroids (systemic); Clinical Comment: Concomitant administration with systemic corticosteroids whose exposures are significantly increased by CYP3A … |
| Digoxin | drug interactions | Concomitant Drug Class/Drug Name: Antiarrhythmics: digoxin; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ digoxin; Clinical Comment: Use with caution and monitor digoxin therapeutic concentration. |
| Dihydroergotamine | drug interactions | Concomitant Drug Class/Drug Name: Ergot derivatives: dihydroergotamine ergotamine methylergonovine; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ dihydroergotamine ↑ ergotamine ↑ methylergonovine; … |
| Edoxaban | drug interactions | Concomitant Drug Class/Drug Name: Anticoagulants: Direct Oral Anticoagulants (DOACs) rivaroxaban dabigatran edoxaban; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ DOAC; Clinical Comment: Refer to the DOAC prescribing information for concomitant administration with moderate CYP3A inhibitors and/or P-gp … |
| Efavirenz | drug interactions | … lenacapavir (atazanavir/cobicistat, atazanavir/ritonavir); Clinical Comment: Concomitant administration of efavirenz, nevirapine, or tipranavir/ritonavir may result in loss of therapeutic effect and development of resistance. |
Every other medicine the lenacapavir label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ergotamine | drug interactions | Concomitant Drug Class/Drug Name: Ergot derivatives: dihydroergotamine ergotamine methylergonovine; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ dihydroergotamine ↑ ergotamine ↑ … |
| Famotidine | drug interactions | … interactions have been observed with: darunavir/cobicistat, cobicistat, famotidine, pitavastatin, rosuvastatin, tenofovir alafenamide, and voriconazole. |
| Fentanyl | drug interactions | Concomitant Drug Class/Drug Name: Narcotic analgesics metabolized by CYP3A: e.g., fentanyl, oxycodone; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ fentanyl ↑ oxycodone; … |
| Hydrocortisone | drug interactions | Concomitant Drug Class/Drug Name: Corticosteroids (systemic): cortisone/hydrocortisone dexamethasone; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ corticosteroids (systemic); … |
| Lovastatin | drug interactions | Concomitant Drug Class/Drug Name: HMG-CoA Reductase Inhibitors: lovastatin simvastatin; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ lovastatin ↑ simvastatin; … |
| Methadone | drug interactions | Initiation of SUNLENCA in patients taking buprenorphine or methadone: A dose adjustment for buprenorphine or methadone may be needed. Monitor clinical signs and symptoms. |
| Methylergonovine | drug interactions | Concomitant Drug Class/Drug Name: Ergot derivatives: dihydroergotamine ergotamine methylergonovine; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ dihydroergotamine ↑ ergotamine ↑ … |
| Midazolam | drug interactions | Concomitant Drug Class/Drug Name: Sedatives/Hypnotics: midazolam (oral) triazolam; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ midazolam (oral) ↑ triazolam; … |
| Naloxegol | drug interactions | Concomitant Drug Class/Drug Name: Opioid Antagonist: naloxegol; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ naloxegol; Clinical Comment: Avoid use with SUNLENCA; … |
| Nevirapine | drug interactions | … atazanavir/ritonavir); Clinical Comment: Concomitant administration of efavirenz, nevirapine, or tipranavir/ritonavir may result in loss of therapeutic effect and development of resistance. |
| Oxcarbazepine | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↓ lenacapavir; … |
| Oxycodone | drug interactions | Concomitant Drug Class/Drug Name: Narcotic analgesics metabolized by CYP3A: e.g., fentanyl, oxycodone; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ fentanyl ↑ oxycodone; … |
| Phenobarbital | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↓ lenacapavir; … |
| Phenytoin | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↓ lenacapavir; … |
| Pitavastatin | drug interactions | … been observed with: darunavir/cobicistat, cobicistat, famotidine, pitavastatin, rosuvastatin, tenofovir alafenamide, and voriconazole. |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin rifampin rifapentine; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↓ lenacapavir; … |
| Rifampin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin rifampin rifapentine; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↓ lenacapavir; … |
| Rifapentine | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin rifampin rifapentine; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↓ lenacapavir; … |
| Ritonavir | drug interactions | Concomitant Drug Class/Drug Name: Antiretroviral Agents: atazanavir/cobicistat Drug-drug interaction study was conducted. atazanavir/ritonavir; … |
| Rivaroxaban | drug interactions | Concomitant Drug Class/Drug Name: Anticoagulants: Direct Oral Anticoagulants (DOACs) rivaroxaban dabigatran edoxaban; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ DOAC; … |
| Rosuvastatin | drug interactions | … with: darunavir/cobicistat, cobicistat, famotidine, pitavastatin, rosuvastatin, tenofovir alafenamide, and voriconazole. |
| Sildenafil | drug interactions | Concomitant Drug Class/Drug Name: Phosphodiesterase-5 (PDE-5) Inhibitors: sildenafil tadalafil vardenafil; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ PDE-5 inhibitors; … |
| Simvastatin | drug interactions | Concomitant Drug Class/Drug Name: HMG-CoA Reductase Inhibitors: lovastatin simvastatin; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ lovastatin ↑ simvastatin; … |
| Tadalafil | drug interactions | Concomitant Drug Class/Drug Name: Phosphodiesterase-5 (PDE-5) Inhibitors: sildenafil tadalafil vardenafil; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ PDE-5 inhibitors; … |
| Tenofovir alafenamide | drug interactions | … darunavir/cobicistat, cobicistat, famotidine, pitavastatin, rosuvastatin, tenofovir alafenamide, and voriconazole. |
| Tramadol | drug interactions | Concomitant Drug Class/Drug Name: tramadol; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ tramadol; Clinical Comment: A decrease in dose may be needed for tramadol with concomitant use. |
| Triazolam | drug interactions | Concomitant Drug Class/Drug Name: Sedatives/Hypnotics: midazolam (oral) triazolam; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ midazolam (oral) ↑ triazolam; … |
| Vardenafil | drug interactions | Concomitant Drug Class/Drug Name: Phosphodiesterase-5 (PDE-5) Inhibitors: sildenafil tadalafil vardenafil; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ PDE-5 inhibitors; … |
| Voriconazole | drug interactions | … famotidine, pitavastatin, rosuvastatin, tenofovir alafenamide, and voriconazole. |
Source: FDA drug label (Sunlenca), Gilead Sciences, Inc., effective August 27, 2026 (SPL set e5652804-29c4-40d7-aeb2-0142ed2a7b5b), via openFDA; the full label on DailyMed
What do FAERS reports show for lenacapavir?
The FDA Adverse Event Reporting System holds 462 reports that list lenacapavir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 8 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 lenacapavir?
43 other medicines are given the same way (oral) and in the same FDA class as lenacapavir 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 lenacapavir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to lenacapavir
- 43 medicines for the same use
- Other human immunodeficiency virus 1 capsid inhibitors
- the pharmacologic class, with prices and generics
- Lenacapavir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other