Prescription medicine
Doravirine Brand names: Pifeltro
Doravirine (Pifeltro) is a prescription medicine with an FDA approval on record since 2018. No generic is listed; pharmacies paid $60.79 per Pifeltro 100 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the doravirine FDA label on DailyMed (effective July 8, 2026, Merck Sharp & Dohme LLC); the NDA 210806 record on Drugs@FDA; every doravirine label on DailyMed.
Highlights of the record
FDA label of July 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePIFELTRO ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment history;
Forms and strengths
- 100 mg
Film-coated tablet.
On the market
- Earliest approval on file
- August 30, 2018 Pifeltro, Msd Merck Co; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- August 30, 2032 Pifeltro tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $60.79 per tablet Pifeltro 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 762 through July 30, 2026
What is doravirine used for?
From the label: indications and usagePIFELTRO ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment history; OR to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine [see Clinical Studies (14) ]. […]
Conditions named in the indications of doravirine'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 (PIFELTRO), Merck Sharp & Dohme LLC, effective July 8, 2026 (SPL set 76ce1f00-28c0-4314-bd2c-d473fe3d0970), via openFDA; the full label on DailyMed
Is there a generic for doravirine (Pifeltro)?
No generic doravirine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Pifeltro 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.
- 2018 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 do pharmacies pay for doravirine (Pifeltro)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $60.79 per Pifeltro 100 mg tablet, up 2% from $59.39 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.
- Pifeltro 100 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pifeltro 100 mg tablet | Brand | $60.79 per tablet | $1,823.61 | +2% |
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 doravirine label say about other medicines?
The doravirine label names 24 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name doravirine. 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 |
|---|---|---|
| Atorvastatin | drug interactions | … co-administered with doravirine: dolutegravir, lamivudine, TDF, elbasvir and grazoprevir, ledipasvir and sofosbuvir, atorvastatin, an oral contraceptive containing ethinyl estradiol and levonorgestrel, metformin, methadone, and midazolam [see Clinical Pharmacology (12.3) ]. |
| Carbamazepine | contraindications | These drugs include, but are not limited to, the following: the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin the androgen receptor inhibitor enzalutamide the antimycobacterials rifampin, rifapentine the cytotoxic agent mitotane St. … |
| Dolutegravir | drug interactions | … significant changes in concentration were observed for doravirine when co-administered with the following agents: dolutegravir, TDF, lamivudine, elbasvir and grazoprevir, ledipasvir and sofosbuvir, ritonavir, ketoconazole, aluminum hydroxide/magnesium hydroxide/simethicone containing antacid, pantoprazole, and … |
| Efavirenz | drug interactions | Concomitant Drug Class/Drug Name: efavirenz etravirine nevirapine; Effect on Concentration: ↓ doravirine; Clinical Comment: Use with efavirenz, etravirine, or nevirapine is not recommended. |
| Enzalutamide | contraindications | These drugs include, but are not limited to, the following: the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin the androgen receptor inhibitor enzalutamide the antimycobacterials rifampin, rifapentine the cytotoxic agent mitotane St. … |
| Etravirine | drug interactions | Concomitant Drug Class/Drug Name: efavirenz etravirine nevirapine; Effect on Concentration: ↓ doravirine; Clinical Comment: Use with efavirenz, etravirine, or nevirapine is not recommended. |
| Ketoconazole | drug interactions | … following agents: dolutegravir, TDF, lamivudine, elbasvir and grazoprevir, ledipasvir and sofosbuvir, ritonavir, ketoconazole, aluminum hydroxide/magnesium hydroxide/simethicone containing antacid, pantoprazole, and methadone [see Clinical Pharmacology (12.3) ]. … |
| Lamivudine | drug interactions | … concentration were observed for doravirine when co-administered with the following agents: dolutegravir, TDF, lamivudine, elbasvir and grazoprevir, ledipasvir and sofosbuvir, ritonavir, ketoconazole, aluminum hydroxide/magnesium hydroxide/simethicone containing antacid, pantoprazole, and methadone [see Clinical … |
| Levonorgestrel | drug interactions | … grazoprevir, ledipasvir and sofosbuvir, atorvastatin, an oral contraceptive containing ethinyl estradiol and levonorgestrel, metformin, methadone, and midazolam [see Clinical Pharmacology (12.3) ]. |
| Magnesium hydroxide | drug interactions | … lamivudine, elbasvir and grazoprevir, ledipasvir and sofosbuvir, ritonavir, ketoconazole, aluminum hydroxide/magnesium hydroxide/simethicone containing antacid, pantoprazole, and methadone [see Clinical Pharmacology (12.3) ]. … |
| Metformin | drug interactions | … ledipasvir and sofosbuvir, atorvastatin, an oral contraceptive containing ethinyl estradiol and levonorgestrel, metformin, methadone, and midazolam [see Clinical Pharmacology (12.3) ]. |
| Methadone | drug interactions | … ritonavir, ketoconazole, aluminum hydroxide/magnesium hydroxide/simethicone containing antacid, pantoprazole, and methadone [see Clinical Pharmacology (12.3) ]. No clinically significant changes in concentration were observed for the following agents when co-administered with doravirine: dolutegravir, lamivudine, TDF … |
| Midazolam | drug interactions | … atorvastatin, an oral contraceptive containing ethinyl estradiol and levonorgestrel, metformin, methadone, and midazolam [see Clinical Pharmacology (12.3) ]. |
| Mitotane | contraindications | These drugs include, but are not limited to, the following: the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin the androgen receptor inhibitor enzalutamide the antimycobacterials rifampin, rifapentine the cytotoxic agent mitotane St. … |
Every other medicine the doravirine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nevirapine | drug interactions | Concomitant Drug Class/Drug Name: efavirenz etravirine nevirapine; Effect on Concentration: ↓ doravirine; Clinical Comment: Use with efavirenz, etravirine, or nevirapine is not recommended. |
| Oxcarbazepine | contraindications | These drugs include, but are not limited to, the following: the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin the androgen receptor inhibitor enzalutamide the … |
| Pantoprazole | drug interactions | … aluminum hydroxide/magnesium hydroxide/simethicone containing antacid, pantoprazole, and methadone [see Clinical Pharmacology (12.3) ]. … |
| Phenobarbital | contraindications | These drugs include, but are not limited to, the following: the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin the androgen receptor inhibitor enzalutamide the … |
| Phenytoin | contraindications | These drugs include, but are not limited to, the following: the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin the androgen receptor inhibitor enzalutamide the … |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: rifabutin; Effect on Concentration: ↓ doravirine; Clinical Comment: Increase PIFELTRO dosage to one tablet twice daily when co-administered with rifabutin [see ]. |
| Rifampin | contraindications | … the androgen receptor inhibitor enzalutamide the antimycobacterials rifampin, rifapentine the cytotoxic agent mitotane St. … |
| Rifapentine | contraindications | … androgen receptor inhibitor enzalutamide the antimycobacterials rifampin, rifapentine the cytotoxic agent mitotane St. John's wort ( Hypericum perforatum) PIFELTRO is contraindicated when … |
| Ritonavir | drug interactions | … TDF, lamivudine, elbasvir and grazoprevir, ledipasvir and sofosbuvir, ritonavir, ketoconazole, aluminum hydroxide/magnesium hydroxide/simethicone containing antacid, pantoprazole, and methadone [see … |
| Sofosbuvir | drug interactions | … dolutegravir, TDF, lamivudine, elbasvir and grazoprevir, ledipasvir and sofosbuvir, ritonavir, ketoconazole, aluminum hydroxide/magnesium hydroxide/simethicone containing antacid, pantoprazole, and … |
Source: FDA drug label (PIFELTRO), Merck Sharp & Dohme LLC, effective July 8, 2026 (SPL set 76ce1f00-28c0-4314-bd2c-d473fe3d0970), via openFDA; the full label on DailyMed
What do FAERS reports show for doravirine?
The FDA Adverse Event Reporting System holds 762 reports that list doravirine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 73 are coded as a death and 185 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 doravirine?
42 other medicines are given the same way (oral) and in the same FDA class as doravirine 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
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to doravirine
- 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 side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other