Prescription medicine
Doravirine and islatravir Brand names: Idvynso
Doravirine and islatravir (Idvynso) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the doravirine and islatravir FDA label on DailyMed (effective April 20, 2026, Merck Sharp & Dohme LLC); the NDA 216964 record on Drugs@FDA; every doravirine and islatravir label on DailyMed.
Highlights of the record
FDA label of April 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIDVYNSO™ is indicated as a complete two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults 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 virologic treatment failure and no known substitutions associated with resistance to doravirine [see Micr
Forms and strengths
- 100 mg / 0.25 mg
Film-coated tablet.
On the market
- Earliest approval on file
- April 20, 2026 Idvynso, Msd; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- August 30, 2032 Idvynso tablets; 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
- 2 through July 30, 2026
What is doravirine and islatravir used for?
From the label: indications and usageIDVYNSO™ is indicated as a complete two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults 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 virologic treatment failure and no known substitutions associated with resistance to doravirine [see Microbiology (12.4) and Clinical Studies (14) ]. […]
Conditions named in the indications of doravirine and islatravir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (IDVYNSO), NDA216964 (Msd), as published by Merck Sharp & Dohme LLC, effective April 20, 2026 (SPL set 11aaeb53-9848-433c-be7f-db8a5bc0b26f), via openFDA; the full label on DailyMed
Is there a generic for doravirine and islatravir (Idvynso)?
No generic doravirine and islatravir is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Idvynso tablets: the compound patent runs to August 30, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2026 earliest approval on file
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the doravirine and islatravir label say about other medicines?
The doravirine and islatravir 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 |
|---|---|---|
| Cladribine | drug interactions | Concomitant Drug Class/Drug Name: Nucleoside Antimetabolites cladribine clofarabine cytarabine fludarabine gemcitabine; Effect on Concentration: ↓ ISL-TP; Clinical Comment: Co-administration with these nucleoside antimetabolites is not recommended as dCK substrates may cause a decrease in the intracellular … |
| Clofarabine | drug interactions | Concomitant Drug Class/Drug Name: Nucleoside Antimetabolites cladribine clofarabine cytarabine fludarabine gemcitabine; Effect on Concentration: ↓ ISL-TP; Clinical Comment: Co-administration with these nucleoside antimetabolites is not recommended as dCK substrates may cause a decrease in the intracellular … |
| Cytarabine | drug interactions | Concomitant Drug Class/Drug Name: Nucleoside Antimetabolites cladribine clofarabine cytarabine fludarabine gemcitabine; Effect on Concentration: ↓ ISL-TP; Clinical Comment: Co-administration with these nucleoside antimetabolites is not recommended as dCK substrates may cause a decrease in the intracellular … |
| Emtricitabine | contraindications | … Warnings and Precautions (5.2), Drug Interactions (7.2), and Clinical Pharmacology (12.3) ]. lamivudine (3TC) or emtricitabine (FTC) as significant decreases in islatravir-triphosphate (ISL-TP) concentrations may occur, which may decrease the effectiveness of IDVYNSO [see Warnings and Precautions (5.2), Drug … |
| Fludarabine | drug interactions | Concomitant Drug Class/Drug Name: Nucleoside Antimetabolites cladribine clofarabine cytarabine fludarabine gemcitabine; Effect on Concentration: ↓ ISL-TP; Clinical Comment: Co-administration with these nucleoside antimetabolites is not recommended as dCK substrates may cause a decrease in the intracellular … |
| Gemcitabine | drug interactions | Concomitant Drug Class/Drug Name: Nucleoside Antimetabolites cladribine clofarabine cytarabine fludarabine gemcitabine; Effect on Concentration: ↓ ISL-TP; Clinical Comment: Co-administration with these nucleoside antimetabolites is not recommended as dCK substrates may cause a decrease in the intracellular … |
| Lamivudine | contraindications | … IDVYNSO [see Warnings and Precautions (5.2), Drug Interactions (7.2), and Clinical Pharmacology (12.3) ]. lamivudine (3TC) or emtricitabine (FTC) as significant decreases in islatravir-triphosphate (ISL-TP) concentrations may occur, which may decrease the effectiveness of IDVYNSO [see Warnings and Precautions (5.2) … |
| Pentostatin | drug interactions | Concomitant Drug Class/Drug Name: pentostatin; Effect on Concentration: ↑ islatravir; Clinical Comment: Co-administration with pentostatin is not recommended as it may cause an increase in plasma concentrations of islatravir. |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Moderate CYP3A Inducers; Effect on Concentration: ↓ doravirine; Clinical Comment: If IDVYNSO is co-administered with rifabutin Interactions were evaluated in clinical studies. … |
Source: FDA drug label (IDVYNSO), NDA216964 (Msd), as published by Merck Sharp & Dohme LLC, effective April 20, 2026 (SPL set 11aaeb53-9848-433c-be7f-db8a5bc0b26f), via openFDA; the full label on DailyMed
What do FAERS reports show for doravirine and islatravir?
The FDA Adverse Event Reporting System holds 2 reports that list doravirine and islatravir 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 1 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 doravirine and islatravir?
42 other medicines are given the same way (oral) and in the same FDA class as doravirine and islatravir 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 |
|---|---|---|---|---|
| Etravirine | HIV | 5 labelers | $9.94 per tablet 200 mg tablet | A presentation being discontinued |
| Nevirapine | HIV | 6 labelers | $0.147 per tablet 200 mg tablet | No current entry |
| Efavirenz | HIV | 5 labelers | $1.28 per tablet 600 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 |
| Rilpivirine | HIV | 2 labelers | $48.04 per tablet 25 mg tablet | No current entry |
| Efavirenz and lamivudine and tenofovir disoproxil | HIV | 1 labeler | n/a | No current entry |
| Emtricitabine and rilpivirine and tenofovir disoproxil | HIV | 2 labelers | $114.50 per tablet 200-25-300 mg tablet | No current entry |
| Dolutegravir and rilpivirine | HIV | none listed | $121.87 per tablet 50-25 mg tablet | No current entry |
Every medicine labeled for the same conditions as doravirine and islatravir
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to doravirine and islatravir
- 42 medicines for the same use
- Other human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Doravirine and islatravir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other