Rukobia Generic: When Will Generic Fostemsavir 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
Rukobia Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July 2029 About 3 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? July 2029 2 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic fostemsavir tromethamine is expected to be available in July 2029, about 3 years away. None is for sale yet.
Why July 2029?
It is when Rukobia’s patent 8,168,615 ends. That patent covers the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
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 Rukobia 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.
Rukobia by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- $265M a yearBig seller
- FDA approved 2020 July 2020 FDA Orange Book
- Patents listed 2 last runs to July 2029 FDA Orange Book
- Pharmacies pay $156.84 per tablet NADAC, October 2026
- Medicare Part D spent $132.6M in 2025, for 1,677 people CMS Part D Spending by Drug
- Medicaid prescriptions 2,430 in the last four reported quarters, $22.3M CMS Medicaid drug utilization, to Q4 2025
Rukobia’s Road to a Generic
Rukobia has had the market to itself since the FDA approved it in July 2020 (Viiv Healthcare Co). Its 2 listed patents run to July 2029.
The first generic of Rukobia is expected in July 2029.
Why that month: patent 8,168,615, on the product’s formulation, 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.
Rukobia Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Rukobia’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 8,168,615, which ends in July 2029, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,745,625 | The active ingredient | November 2027 | Active |
| 8,168,615 Sets the expected month of generic availability | The product’s formulation | July 2029 | Active |
Source: FDA Orange Book, application 212950. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Fostemsavir Tromethamine
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 Rukobia yet.
Approved by the FDA
Not yet. The FDA has not approved a generic fostemsavir tromethamine. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic fostemsavir tromethamine 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).
Rukobia Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Rukobia ER 600 mg tablet
$156.84 per tablet in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $156.84 |
| September 2026 | $156.84 |
| August 2026 | $156.84 |
| July 2026 | $156.84 |
| June 2026 | $156.87 |
| May 2026 | $156.87 |
| April 2026 | $156.87 |
| March 2026 | $156.87 |
| February 2026 | $156.87 |
| January 2026 | $156.87 |
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 Rukobia today: $156.84 per tablet for Rukobia ER 600 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 $156.84 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 Rukobia
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 Rukobia, before manufacturer rebates.
- $33.8M
- January to March 2026, the latest CMS has posted
For 1,366 people, about $9,410 per prescription fill - $132.6M
- 2025, the whole year
For 1,677 people, about $9,232 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $33,755,373 | 1,366 | $9,410.47 |
| 2025 | $132,569,198 | 1,677 | $9,231.84 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Rukobia 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
2,430 prescriptions in the four quarters to Q4 2025, $22.3M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q4 2025 | 615 | $5,628,371 |
| Q3 2025 | 672 | $6,075,351 |
| Q2 2025 | 569 | $5,181,035 |
| Q1 2025 | 574 | $5,413,346 |
Source: CMS Medicaid State Drug Utilization Data, over Rukobia’s own package codes.
Rukobia Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 600MG BASE | Tablet, extended release | Oral | July 2020 | Prescription reference product |
Source: FDA Orange Book, Viiv Healthcare Co. Listed for sale today by ViiV Healthcare Company (FDA NDC Directory).
Rukobia NDC Codes and Packages
Each Rukobia 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 |
|---|---|---|---|
| 49702-0250-18 | FOSTEMSAVIR TROMETHAMINE 600 mg/1 tablet, film coated, extended release | bottle of 60 tablets | ViiV Healthcare Company |
| 49702-0250-18 | FOSTEMSAVIR TROMETHAMINE 600 mg/1 tablet, film coated, extended release | bottle of 60 tablets | ViiV Healthcare Company |
Source: the FDA NDC Directory, current listings only. Only packages sold under Rukobia’s own FDA approval (NDA 212950) are listed, never a generic. Some codes belong to companies that repackage Rukobia: it is the same medicine in a different package.
What a Generic Rukobia Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Rukobia 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 Rukobia”. 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 Rukobia
Is there a generic for Rukobia right now?
No. As of October 9, 2026 no generic fostemsavir tromethamine is listed for sale in the FDA NDC Directory.
When will Rukobia go generic?
July 2029 is the expected month, and that is probable but not certain. It is when Rukobia’s patent 8,168,615 ends. That patent covers the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic fostemsavir tromethamine be the same as Rukobia?
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 Rukobia?
Not yet. The FDA Orange Book lists no approved generic version of Rukobia.
When does the Rukobia patent expire?
The FDA Orange Book lists 2 patents for Rukobia; the last runs to July 2029. The one behind the expected month is patent 8,168,615, which ends in July 2029. 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 (July 2029) weighs all of that.
How much does Rukobia cost now?
Pharmacies paid about $156.84 per tablet for Rukobia ER 600 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 July 2029 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
- FexinidazoleFexinidazoleJuly 2028
- PhexxCitric Acid, L-Lactic Acid, and Potassium BitartrateMarch 2033
- Levothyroxine SodiumLevothyroxine SodiumJuly 2036
- XyostedTestosterone EnanthateSeptember 2036
- BlujepaGepotidacin Mesylate2038 to 2039
- TazverikTazemetostat HydrobromideTBD no date yet
About Rukobia
- Generic name fostemsavir tromethamine
- How it is taken By mouth
- Company Viiv Healthcare Co
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with R
- Have a question? A pharmacist answers, free. Ask about Rukobia
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.