Biktarvy Generic: When Will It 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
Biktarvy Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? April 2036 About 9.5 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? November 2036 9 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate is expected to be available in April 2036, about 9.5 years away, first for Biktarvy 50 mg/200 mg/25 mg. None is for sale yet. Each product has its own month below.
Why April 2036?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it very likely: few things could still move it, but a court ruling or a new deal can.
If Biktarvy’s last patent runs to November 2036, how can a generic come sooner?
The 3 patents that run past the expected month, to November 2036 (10,548,846, 11,744,802 and 12,594,244), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, a settlement between the companies sets the date. Generic companies have been challenging Biktarvy’s patents with the FDA since February 2022. That is why the expected month comes before the last protection ends. See the road to a generic
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, and more so as more companies sell one. 3 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic, which would take the $136.73 pharmacies pay per tablet for Biktarvy today to about $76.57. See the price estimate
What should I do now?
Keep taking Biktarvy 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
- 30 mg/120 mg/15 mgSometime in 2035Probable · settlement between companies
- 50 mg/200 mg/25 mgApril 2036Very likely · settlement between companies
Our month is only an estimate based on available information, so we never name a day.
Biktarvy by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Very likely Few things could still move it, but a court ruling or a new deal can.
- Price competition
- Moderate 3 companies have filed, 3 first in line
- Brand sales
- $19.4B a yearBlockbuster
- FDA approved 2018 February 2018 FDA Orange Book
- Patents listed 9 last runs to November 2036 A generic is expected sooner, in April 2036. See why FDA Orange Book
- Pharmacies pay $136.73 per tablet, up 5.9% in a year NADAC, October 2026
- Medicare Part D spent $4B in 2025, for 101.6K people CMS Part D Spending by Drug
- Medicaid prescriptions 768.8K in the last four reported quarters, $3.5B CMS Medicaid drug utilization, to Q1 2026
Biktarvy’s Road to a Generic
Biktarvy has had the market to itself since the FDA approved it in February 2018 (Gilead Sciences Inc). Its FDA protection (orphan drug) runs to July 2032. Its 9 listed patents run to November 2036. Generic companies have challenged its patents with the FDA since February 2022.
The first generic of Biktarvy is expected in April 2036.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch. That is a few months before the last listed patent runs out, in November 2036.
Why a Generic Can Come Before November 2036
The last listed patent runs to November 2036, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
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.
Biktarvy Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Biktarvy’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.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,754,065 | The active ingredient; the product’s formulation; a way of using it (U-257) | February 2033 with the pediatric extension | Active |
| 9,296,769 | The active ingredient; the product’s formulation; a way of using it (U-257) | February 2033 with the pediatric extension | Active |
| 9,216,996 | The active ingredient; the product’s formulation | December 2033 | Active |
| 9,732,092 | The active ingredient; the product’s formulation | December 2033 | Active |
| 9,708,342 | The active ingredient; the product’s formulation | June 2035 | Active |
| 10,385,067 | A way of using it (U-257) | June 2035 | Active |
| 10,548,846 | The product’s formulation | November 2036 | Active |
| 11,744,802 | The product’s formulation | November 2036 | Active |
| 12,594,244 | The product’s formulation; a way of using it (U-257) | November 2036 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| Orphan drug ODE-256 | Seven years of protection for a use in a rare disease. | June 2026 | Ended |
| New use I-942 | Three years of protection for a newly approved use (indication). | February 2027 | Active |
| New clinical information M-305 | Three years of protection for a change backed by new clinical studies. | April 2027 | Active |
| Orphan drug ODE-378 | Seven years of protection for a use in a rare disease. | October 2028 | Active |
| Orphan drug ODE-468 | Seven years of protection for a use in a rare disease. | February 2031 | Active |
| Orphan drug ODE-540 | Seven years of protection for a use in a rare disease. | July 2032 | Active |
Source: FDA Orange Book, application 210251. Patent numbers open the patent on Google Patents.
Patent Challenges to Biktarvy
The first patent challenge to Biktarvy reached the FDA in February 2022, from 3 companies on that first day. The FDA’s list has 2 entries for Biktarvy, by form and strength. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Biktarvy’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Tablets, 50 mg/200 mg/25 mg | February 2022 | 3 companies | No decision yet | Not yet | Not yet | November 2036 |
| Tablets, 30 mg/120 mg/15 mg | September 2023 | 1 company | No decision yet | Not yet | Not yet | June 2035 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Bictegravir Sodium, Emtricitabine, and Tenofovir Alafenamide Fumarate
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
3 companies have applied to the FDA to make generic bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for these yet, so the companies are not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. 3 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Biktarvy’s patents with the FDA since February 2022: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate 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).
Biktarvy Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Biktarvy 50-200-25 mg tablet
$136.73 per tablet in October 2026, up 5.9% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
- Biktarvy 30-120-15 mg tablet $136.66 per tablet
- Biktarvy 50-200-25 mg tablet $136.73 per tablet
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $136.73 |
| September 2026 | $136.73 |
| August 2026 | $136.73 |
| July 2026 | $136.75 |
| June 2026 | $136.74 |
| May 2026 | $136.74 |
| April 2026 | $136.73 |
| March 2026 | $136.74 |
| February 2026 | $136.74 |
| January 2026 | $136.70 |
| February 2024 | $129.12 |
| January 2024 | $129.12 |
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 Biktarvy today: $136.73 per tablet for Biktarvy 50-200-25 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). Biktarvy has 3 companies lined up, so our estimate uses the figure for two companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $136.73 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 Biktarvy
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 Biktarvy, before manufacturer rebates.
- $996.5M
- January to March 2026, the latest CMS has posted
For 91,361 people, about $4,220 per prescription fill - $4B
- 2025, the whole year
For 101,565 people, about $4,313 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $996,492,695 | 91,361 | $4,220.10 |
| 2025 | $4,011,392,691 | 101,565 | $4,313.25 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Biktarvy only, so no generic is counted in it. What CMS says it is used for: This combination product is used by itself 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
768,801 prescriptions in the four quarters to Q1 2026, $3.5B paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 182,132 | $847,801,516 |
| Q4 2025 | 195,661 | $898,382,834 |
| Q3 2025 | 199,785 | $920,373,635 |
| Q2 2025 | 191,223 | $868,059,345 |
| Q1 2025 | 192,365 | $864,021,056 |
Source: CMS Medicaid State Drug Utilization Data, over Biktarvy’s own package codes.
Biktarvy Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 50MG BASE;200MG;EQ 25MG BASE | Tablet | Oral | February 2018 | Prescription reference product |
| EQ 30MG BASE;120MG;EQ 15MG BASE | Tablet | Oral | October 2021 | Prescription reference product |
Source: FDA Orange Book, Gilead Sciences Inc. Listed for sale today by Gilead Sciences, Inc. and A-S Medication Solutions (FDA NDC Directory).
Biktarvy NDC Codes and Packages
Each Biktarvy 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 |
|---|---|---|---|
| 61958-2505-01 | BICTEGRAVIR SODIUM 30 mg/1 / EMTRICITABINE 120 mg/1 / TENOFOVIR ALAFENAMIDE FUMARATE 15 mg/1 tablet | bottle of 30 tablets | Gilead Sciences, Inc. |
| 61958-2505-01 | BICTEGRAVIR SODIUM 30 mg/1 / EMTRICITABINE 120 mg/1 / TENOFOVIR ALAFENAMIDE FUMARATE 15 mg/1 tablet | bottle of 30 tablets | Gilead Sciences, Inc. |
| 61958-2506-01 | BICTEGRAVIR SODIUM 30 mg/1 / EMTRICITABINE 120 mg/1 / TENOFOVIR ALAFENAMIDE FUMARATE 15 mg/1 tablet | bottle of 30 tablets | Gilead Sciences, Inc. |
| 50090-6247-00 | BICTEGRAVIR SODIUM 50 mg/1 / EMTRICITABINE 200 mg/1 / TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1 tablet | bottle of 30 tablets | A-S Medication Solutions |
| 50090-6247-00 | BICTEGRAVIR SODIUM 50 mg/1 / EMTRICITABINE 200 mg/1 / TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1 tablet | bottle of 30 tablets | A-S Medication Solutions |
| 61958-2501-01 | BICTEGRAVIR SODIUM 50 mg/1 / EMTRICITABINE 200 mg/1 / TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1 tablet | bottle of 30 tablets | Gilead Sciences, Inc. |
| 61958-2501-01 | BICTEGRAVIR SODIUM 50 mg/1 / EMTRICITABINE 200 mg/1 / TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1 tablet | bottle of 30 tablets | Gilead Sciences, Inc. |
| 61958-2501-02 | BICTEGRAVIR SODIUM 50 mg/1 / EMTRICITABINE 200 mg/1 / TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1 tablet | bottle of 7 tablets | Gilead Sciences, Inc. |
Show the other 4 Biktarvy packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 61958-2501-02 | BICTEGRAVIR SODIUM 50 mg/1 / EMTRICITABINE 200 mg/1 / TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1 tablet | bottle of 7 tablets | Gilead Sciences, Inc. |
| 61958-2501-03 | BICTEGRAVIR SODIUM 50 mg/1 / EMTRICITABINE 200 mg/1 / TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1 tablet | blister pack of 30 tablets | Gilead Sciences, Inc. |
| 61958-2501-03 | BICTEGRAVIR SODIUM 50 mg/1 / EMTRICITABINE 200 mg/1 / TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1 tablet | blister pack of 30 tablets | Gilead Sciences, Inc. |
| 61958-2501-05 | BICTEGRAVIR SODIUM 50 mg/1 / EMTRICITABINE 200 mg/1 / TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1 tablet | blister pack of 30 tablets | Gilead Sciences, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Biktarvy’s own FDA approval (NDA 210251) are listed, never a generic. Some codes belong to companies that repackage Biktarvy: it is the same medicine in a different package.
What a Generic Biktarvy Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Biktarvy 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 Biktarvy”. 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 Biktarvy
Is there a generic for Biktarvy right now?
No. As of October 9, 2026 no generic bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate is listed for sale in the FDA NDC Directory.
When will Biktarvy go generic?
April 2036 is the expected month, and that is very likely but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to November 2036, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate be the same as Biktarvy?
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. 3 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic, which would take the $136.73 pharmacies pay per tablet for Biktarvy today to about $76.57. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Biktarvy?
Not yet. The FDA Orange Book lists no approved generic version of Biktarvy.
When does the Biktarvy patent expire?
The FDA Orange Book lists 9 patents for Biktarvy; the last runs to November 2036. 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 (April 2036) weighs all of that.
Has anyone challenged the Biktarvy patents?
Yes. The first patent challenge to Biktarvy reached the FDA in February 2022, from 3 companies on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
How much does Biktarvy cost now?
Pharmacies paid about $136.73 per tablet for Biktarvy 50-200-25 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 April 2036 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
- Norepinephrine Bitartrate in DextroseDextrose and Norepinephrine Bitartrate2026 to 2027
- VerdesoDesonideNovember 2028
- RykindoRisperidoneApril 2032
- InqoviCedazuridine and DecitabineFebruary 2034
- AkeegaAbiraterone Acetate and Niraparib TosylateJuly 2037
- DetectnetCopper Cu-64 DotatateSeptember 2041
About Biktarvy
- Generic name bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
- How it is taken By mouth
- Company Gilead Sciences Inc
- Patent challenges Since February 2022 (FDA)
- More drugs Brand-name drugs starting with B
- Have a question? A pharmacist answers, free. Ask about Biktarvy
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, FDA Paragraph IV Patent Certifications list, 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.