Vemlidy Generic: When Will Generic Tenofovir Alafenamide 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
Vemlidy Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? October 2031 About 5 years away Why then?
- Has the FDA approved a generic? March 2023 1 company approved Why not on sale?
- When does the last patent end? February 2033 2 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 tenofovir alafenamide fumarate is expected to be available in October 2031, about 5 years away. None is for sale yet.
Why October 2031?
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 Vemlidy’s last patent runs to February 2033, how can a generic come sooner?
The 2 patents that run past the expected month, to February 2033 (8,754,065 and 9,296,769), cover the active ingredient, the product’s formulation and a way of using it. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. Here, a settlement between the companies sets the date. Generic companies have been challenging Vemlidy’s patents with the FDA since November 2019. That is why the expected month comes before the last protection ends. See the road to a generic
If the FDA approved a generic, why can’t I buy one?
FDA approval is permission to sell, not a launch. One company has held an approval since March 2023, but a patent, a settlement or a company’s own plans can hold a generic back until the expected month. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 8 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $51.98 pharmacies pay per tablet for Vemlidy today to under $2.60. See the price estimate
What should I do now?
Keep taking Vemlidy 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.
Vemlidy 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
- Very strong 8 companies have filed, 6 first in line
- Brand sales
- Sales not reported
- FDA approved 2016 November 2016 FDA Orange Book
- Patents listed 2 last runs to February 2033 A generic is expected sooner, in October 2031. See why FDA Orange Book
- Generics FDA-approved 1 company, approved March 2023 FDA Orange Book
- Pharmacies pay $51.98 per tablet, up 12% in a year NADAC, October 2026
- Medicare Part D spent $231M in 2025, for 16.3K people CMS Part D Spending by Drug
- Medicaid prescriptions 72K in the last four reported quarters, $119.8M CMS Medicaid drug utilization, to Q1 2026
Vemlidy’s Road to a Generic
Vemlidy has had the market to itself since the FDA approved it in November 2016 (Gilead Sciences Inc). Its FDA protection (new patient population) runs to March 2027. Its 2 listed patents run to February 2033. Generic companies have challenged its patents with the FDA since November 2019.
The first generic of Vemlidy is expected in October 2031.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch. That is about 1.5 years before the last listed patent runs out, in February 2033.
Why a Generic Can Come Before February 2033
The last listed patent runs to February 2033; a court ruling or a settlement can bring a generic sooner. 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.
Vemlidy Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Vemlidy’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-999, U-1275, U-3880) | February 2033 with the pediatric extension | Active |
| 9,296,769 | The active ingredient; the product’s formulation; a way of using it (U-1275, U-3880, U-999) | February 2033 with the pediatric extension | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New patient population NPP | Three years of protection for a newly approved group of patients. | March 2027 | Active |
Source: FDA Orange Book, application 208464. Patent numbers open the patent on Google Patents.
Patent Challenges to Vemlidy
The first patent challenge to Vemlidy reached the FDA in November 2019, from 6 companies on that first day. The FDA approved a first challenger’s generic in March 2023, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Vemlidy’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, 25 mg | November 2019 | 6 companies | First challenger eligible decided April 2023 | March 2023 | Not yet | August 2032 |
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 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
8 companies have applied to the FDA to make generic tenofovir alafenamide fumarate.
The FDA has tentatively approved one company’s generic: Laurus Labs Ltd (July 2026). A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. 6 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 Vemlidy’s patents with the FDA since November 2019: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 1 company, the first in March 2023. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Not yet. No company lists a generic tenofovir alafenamide fumarate for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Lupin Ltd | March 2023 | EQ 25MG BASE | AB |
| Apotex Inc discontinued | March 2024 | EQ 25MG BASE | – |
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).
Vemlidy Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Vemlidy 25 mg tablet
$51.98 per tablet in October 2026, up 12% 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 | $51.98 |
| September 2026 | $51.98 |
| August 2026 | $51.98 |
| July 2026 | $51.98 |
| June 2026 | $51.94 |
| May 2026 | $51.93 |
| April 2026 | $51.93 |
| March 2026 | $51.93 |
| February 2026 | $51.93 |
| January 2026 | $51.93 |
| February 2024 | $46.41 |
| January 2024 | $46.41 |
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 Vemlidy today: $51.98 per tablet for Vemlidy 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). Vemlidy has 8 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $51.98 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 Vemlidy
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 Vemlidy, before manufacturer rebates.
- $61.8M
- January to March 2026, the latest CMS has posted
For 14,484 people, about $1,689 per prescription fill - $231M
- 2025, the whole year
For 16,287 people, about $1,618 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $61,766,927 | 14,484 | $1,689.24 |
| 2025 | $231,036,039 | 16,287 | $1,618.18 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Vemlidy only, so no generic is counted in it. What CMS says it is used for: Tenofovir alafenamide is used to treat chronic hepatitis B infection, a viral infection of the liver. It works by stopping or slowing the growth of the virus.
Medicaid Prescriptions by Quarter
72,030 prescriptions in the four quarters to Q1 2026, $119.8M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 17,599 | $30,346,747 |
| Q4 2025 | 18,342 | $30,109,795 |
| Q3 2025 | 19,403 | $31,843,096 |
| Q2 2025 | 16,686 | $27,507,484 |
| Q1 2025 | 17,938 | $29,133,299 |
Source: CMS Medicaid State Drug Utilization Data, over Vemlidy’s own package codes.
Vemlidy Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 25MG BASE | Tablet | Oral | November 2016 | Prescription reference product |
Source: FDA Orange Book, Gilead Sciences Inc. Listed for sale today by Gilead Sciences, Inc. (FDA NDC Directory).
Vemlidy NDC Codes and Packages
Each Vemlidy 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 |
|---|---|---|---|
| 61958-2301-01 | TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1 tablet | bottle of 30 tablets | Gilead Sciences, Inc. |
| 61958-2301-01 | TENOFOVIR ALAFENAMIDE FUMARATE 25 mg/1 tablet | bottle of 30 tablets | Gilead Sciences, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Vemlidy’s own FDA approval (NDA 208464) are listed, never a generic. Some codes belong to companies that repackage Vemlidy: it is the same medicine in a different package.
What a Generic Vemlidy Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Vemlidy 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 Vemlidy”. 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 Vemlidy
Is there a generic for Vemlidy right now?
No. As of October 9, 2026 no generic tenofovir alafenamide fumarate is listed for sale in the FDA NDC Directory. 2 generic versions are FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Vemlidy go generic?
October 2031 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 February 2033; a court ruling or a settlement can bring a generic sooner.
Will generic tenofovir alafenamide fumarate be the same as Vemlidy?
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. 8 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $51.98 pharmacies pay per tablet for Vemlidy today to under $2.60. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Vemlidy?
Yes. The FDA Orange Book lists approved generic versions from 1 company, the first approved in March 2023: Lupin Ltd. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Vemlidy patent expire?
The FDA Orange Book lists 2 patents for Vemlidy; the last runs to February 2033, counting a six-month pediatric extension. 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 (October 2031) weighs all of that.
Has anyone challenged the Vemlidy patents?
Yes. The first patent challenge to Vemlidy reached the FDA in November 2019, from 6 companies on that first day. The FDA approved a first challenger’s generic in March 2023, and the list records no sale by a first challenger 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 Vemlidy cost now?
Pharmacies paid about $51.98 per tablet for Vemlidy 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 October 2031 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
- FetzimaLevomilnacipran Hydrochloride2029 to 2030
- BludigoIndigotindisulfonate Sodium2032 to 2033
- TavalisseFostamatinib DisodiumApril to June 2032
- XphozahTenapanor HydrochlorideApril 2034
- LeqvioInclisiranDuring 2036
- Phenylephrine HydrochloridePhenylephrine HydrochlorideTBD no date yet
About Vemlidy
- Generic name tenofovir alafenamide fumarate
- How it is taken By mouth
- Company Gilead Sciences Inc
- Patent challenges Since November 2019 (FDA)
- More drugs Brand-name drugs starting with V
- Have a question? A pharmacist answers, free. Ask about Vemlidy
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.