Pifeltro Generic: When Will Generic Doravirine Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Pifeltro Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? August 2032 About 6 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? August 2032 Its only patent listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic doravirine is expected to be available in August 2032, about 6 years away. None is for sale yet.
Why August 2032?
It is when Pifeltro’s patent 8,486,975 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it likely: firm enough to plan around, but a court ruling or a new deal could still move it.
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Pifeltro as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Pifeltro by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Likely Firm enough to plan around, but a court ruling or a new deal could still move it.
- Price competition
- None filed yet No filers on record
- Brand sales
- $165M a yearBig seller
- FDA approved 2018 August 2018 FDA Orange Book
- Patents listed 1 last runs to August 2032 FDA Orange Book
- Pharmacies pay $60.79 per tablet, up 6.6% in a year NADAC, October 2026
- Medicare Part D spent $88.2M in 2025, for 5,075 people CMS Part D Spending by Drug
- Medicaid prescriptions 11.6K in the last four reported quarters, $22.2M CMS Medicaid drug utilization, to Q4 2025
Pifeltro’s Road to a Generic
Pifeltro has had the market to itself since the FDA approved it in August 2018 (Merck Sharp And Dohme Corp A Sub Of Merck And Co Inc). Its one listed patent runs to August 2032.
The first generic of Pifeltro is expected in August 2032.
Why that month: patent 8,486,975, on the active ingredient, the product’s formulation and a way of using it, ends then.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Pifeltro Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Pifeltro’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
The one that matters for a generic launch: patent 8,486,975, which ends in August 2032, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,486,975 Sets the expected month of generic availability | The active ingredient; the product’s formulation; a way of using it (U-2630, U-2394, U-3308) | August 2032 | Active |
Source: FDA Orange Book, application 210806. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Doravirine
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No company is recorded as having applied to the FDA to make a generic Pifeltro yet.
Approved by the FDA
Not yet. The FDA has not approved a generic doravirine. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic doravirine for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Pifeltro Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Pifeltro 100 mg tablet
$60.79 per tablet in October 2026, up 6.6% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $60.79 |
| September 2026 | $60.79 |
| August 2026 | $60.70 |
| July 2026 | $60.77 |
| June 2026 | $60.76 |
| May 2026 | $60.78 |
| April 2026 | $60.95 |
| March 2026 | $60.95 |
| February 2026 | $60.95 |
| January 2026 | $60.95 |
| February 2024 | $57.05 |
| January 2024 | $57.05 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Pifeltro today: $60.79 per tablet for Pifeltro 100 mg tablet in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Dollar figures apply FDA’s median drops to the $60.79 pharmacies pay per tablet today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Pifeltro
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Pifeltro, before manufacturer rebates.
- $21.8M
- January to March 2026, the latest CMS has posted
For 4,387 people, about $1,952 per prescription fill - $88.2M
- 2025, the whole year
For 5,075 people, about $1,945 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $21,798,247 | 4,387 | $1,952.37 |
| 2025 | $88,234,818 | 5,075 | $1,944.65 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Pifeltro only, so no generic is counted in it. What CMS says it is used for: This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better.
Medicaid Prescriptions by Quarter
11,622 prescriptions in the four quarters to Q4 2025, $22.2M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q4 2025 | 2,787 | $5,375,282 |
| Q3 2025 | 3,030 | $5,813,586 |
| Q2 2025 | 2,880 | $5,485,756 |
| Q1 2025 | 2,925 | $5,559,386 |
Source: CMS Medicaid State Drug Utilization Data, over Pifeltro’s own package codes.
Pifeltro Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG | Tablet | Oral | August 2018 | Prescription reference product |
Source: FDA Orange Book, Merck Sharp And Dohme Corp A Sub Of Merck And Co Inc. Listed for sale today by Merck Sharp & Dohme LLC and A-S Medication Solutions (FDA NDC Directory).
Pifeltro NDC Codes and Packages
Each Pifeltro package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 50090-6237-00 | 100 mg tablet, film coated | bottle of 30 tablets | A-S Medication Solutions |
| 00006-3069-01 | DORAVIRINE 100 mg/1 tablet, film coated | bottle of 30 tablets | Merck Sharp & Dohme LLC |
| 00006-3069-01 | DORAVIRINE 100 mg/1 tablet, film coated | bottle of 30 tablets | Merck Sharp & Dohme LLC |
| 50090-6268-00 | DORAVIRINE 100 mg/1 tablet, film coated | bottle of 30 tablets | A-S Medication Solutions |
| 50090-6268-00 | DORAVIRINE 100 mg/1 tablet, film coated | bottle of 30 tablets | A-S Medication Solutions |
Source: the FDA NDC Directory, current listings only. Only packages sold under Pifeltro’s own FDA approval (NDA 210806) are listed, never a generic. Some codes belong to companies that repackage Pifeltro: it is the same medicine in a different package.
What a Generic Pifeltro Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Pifeltro as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Pifeltro”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Pifeltro
Is there a generic for Pifeltro right now?
No. As of October 9, 2026 no generic doravirine is listed for sale in the FDA NDC Directory.
When will Pifeltro go generic?
August 2032 is the expected month, and that is likely but not certain. It is when Pifeltro’s patent 8,486,975 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic doravirine be the same as Pifeltro?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Pifeltro?
Not yet. The FDA Orange Book lists no approved generic version of Pifeltro.
When does the Pifeltro patent expire?
One patent is listed for Pifeltro in the FDA Orange Book; it runs to August 2032. The one behind the expected month is patent 8,486,975, which ends in August 2032. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (August 2032) weighs all of that.
How much does Pifeltro cost now?
Pharmacies paid about $60.79 per tablet for Pifeltro 100 mg tablet in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected August 2032 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- VibativTelavancin HydrochlorideJanuary 2027
- AltabaxRetapamulinFebruary 2027
- SalonpasMenthol and Methyl SalicylateJanuary 2030
- IntrarosaPrasteroneMarch 2031
- NorliqvaAmlodipine BesylateFebruary 2041
- Dilaudid-HPHydromorphone HydrochlorideTBD no date yet
About Pifeltro
- Generic name doravirine
- How it is taken By mouth
- Company Merck Sharp And Dohme Corp A Sub Of Merck And Co Inc
- More drugs Brand-name drugs starting with P
- Have a question? A pharmacist answers, free. Ask about Pifeltro
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.