Sovaldi Generic: When Will Generic Sofosbuvir 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
Sovaldi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? September 2029 About 3 years away Why then?
- Has the FDA approved a generic? January 2022 Since discontinued Why not yet?
- When does the last patent end? June 2031 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 sofosbuvir is expected to be available in September 2029, about 3 years away, first for Sovaldi packets. None is for sale yet. Each product has its own month below.
Why September 2029?
It is when Sovaldi’s patent 7,964,580 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Sovaldi’s last patent runs to June 2031, how can a generic come sooner?
The 2 patents that run past the expected month, to June 2031 (9,284,342 and 8,618,076), 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. Generic companies have been challenging Sovaldi’s patents with the FDA since December 2017. 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, 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 Sovaldi 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
- tablets2029 to 2030Probable · settlement between companies
- packetsSeptember 2029Probable · patent expires
Our month is only an estimate based on available information, so we never name a day.
Sovaldi 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
- Sales not reported
- FDA approved 2013 December 2013 FDA Orange Book
- Patents listed 9 last runs to June 2031 A generic is expected sooner, in September 2029. See why FDA Orange Book
- Medicare Part D spent $1.9M in 2025, for 20 people CMS Part D Spending by Drug
Sovaldi’s Road to a Generic
Sovaldi has had the market to itself since the FDA approved it in December 2013 (Gilead Sciences Inc). Its FDA protections on record ended by August 2026. Its 9 listed patents run to June 2031. Generic companies have challenged its patents with the FDA since December 2017.
The first generic of Sovaldi is expected in September 2029.
Why that month: patent 7,964,580, on the active ingredient, the product’s formulation and a way of using it, ends then. That is about 1.5 years before the last listed patent runs out, in June 2031.
Why a Generic Can Come Before June 2031
The last listed patent runs to June 2031; 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.
Sovaldi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Sovaldi’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 7,964,580, which ends in September 2029, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,334,270 | The active ingredient; the product’s formulation; a way of using it (U-1470) | September 2028 with the pediatric extension | Active |
| 8,580,765 | The active ingredient; the product’s formulation; a way of using it (U-1470) | September 2028 with the pediatric extension | Active |
| 9,085,573 | The active ingredient; the product’s formulation; a way of using it (U-1470) | September 2028 with the pediatric extension | Active |
| 7,964,580 Sets the expected month of generic availability | The active ingredient; the product’s formulation; a way of using it (U-1470) | September 2029 with the pediatric extension | Active |
| 8,633,309 | The active ingredient; the product’s formulation; a way of using it (U-1470) | September 2029 with the pediatric extension | Active |
| 8,889,159 | The product’s formulation; a way of using it (U-1470) | September 2029 with the pediatric extension | Active |
| 9,549,941 | A way of using it (U-1958) | September 2029 with the pediatric extension | Active |
| 9,284,342 | The active ingredient; the product’s formulation; a way of using it (U-1470) | March 2031 with the pediatric extension | Active |
| 8,618,076 | The active ingredient; the product’s formulation; a way of using it (U-1470) | June 2031 with the pediatric extension | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| FDA exclusivity ODE* | A period of protection the FDA granted (code ODE*). | August 2026 | Ended |
| Orphan drug ODE-258 | Seven years of protection for a use in a rare disease. | August 2026 | Ended |
Source: FDA Orange Book, application 212480, 204671. Patent numbers open the patent on Google Patents.
Patent Challenges to Sovaldi
The first patent challenge to Sovaldi reached the FDA in December 2017, from 2 companies on that first day. The FDA approved a first challenger’s generic in January 2022, 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 Sovaldi’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, 400 mg | December 2017 | 2 companies | Decision deferred decided February 2022 | January 2022 | Not yet | December 2030 |
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 Sofosbuvir
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 Sovaldi yet.
Generic companies have challenged Sovaldi’s patents with the FDA since December 2017: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic sofosbuvir. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic sofosbuvir for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Teva Pharmaceuticals USA Inc discontinued | January 2022 | 400MG | – |
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).
Sovaldi Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Sovaldi, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay 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).
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 Sovaldi
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 Sovaldi, before manufacturer rebates.
- $492.3K
- January to March 2026, the latest CMS has posted
About $25,909 per prescription fill - $1.9M
- 2025, the whole year
For 20 people, about $26,457 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $492,262 | – | $25,908.55 |
| 2025 | $1,878,465 | 20 | $26,457.26 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Sovaldi only, so no generic is counted in it. What CMS says it is used for: Sofosbuvir is used with other antiviral medications (such as ribavirin, peginterferon, daclatasvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It works by reducing the amount of hepatitis C virus in your body, which may help your liver recover.
Sovaldi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 400MG | Tablet | Oral | December 2013 | Prescription reference product |
| 150MG/PACKET | Pellets | Oral | August 2019 | Prescription reference product |
| 200MG | Tablet | Oral | August 2019 | Prescription reference product |
| 200MG/PACKET | Pellets | Oral | August 2019 | Prescription reference product |
Source: FDA Orange Book, Gilead Sciences Inc. Listed for sale today by Gilead Sciences, Inc. (FDA NDC Directory).
Sovaldi NDC Codes and Packages
Each Sovaldi 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 |
|---|---|---|---|
| 61958-1504-01 | SOFOSBUVIR 150 mg/1 pellet | packet of 60 pellets | Gilead Sciences, Inc. |
| 61958-1504-01 | SOFOSBUVIR 150 mg/1 pellet | packet of 60 pellets | Gilead Sciences, Inc. |
| 61958-1505-01 | SOFOSBUVIR 200 mg/1 pellet | packet of 80 pellets | Gilead Sciences, Inc. |
| 61958-1505-01 | SOFOSBUVIR 200 mg/1 pellet | packet of 80 pellets | Gilead Sciences, Inc. |
| 61958-1503-01 | SOFOSBUVIR 200 mg/1 tablet, film coated | bottle of 28 tablets | Gilead Sciences, Inc. |
| 61958-1503-01 | SOFOSBUVIR 200 mg/1 tablet, film coated | bottle of 28 tablets | Gilead Sciences, Inc. |
| 61958-1501-01 | SOFOSBUVIR 400 mg/1 tablet, film coated | bottle of 28 tablets | Gilead Sciences, Inc. |
| 61958-1501-01 | SOFOSBUVIR 400 mg/1 tablet, film coated | bottle of 28 tablets | Gilead Sciences, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Sovaldi’s own FDA approval (NDA 212480, NDA 204671) are listed, never a generic. Some codes belong to companies that repackage Sovaldi: it is the same medicine in a different package.
What a Generic Sovaldi Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Sovaldi 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 Sovaldi”. 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 Sovaldi
Is there a generic for Sovaldi right now?
No. As of October 9, 2026 no generic sofosbuvir is listed for sale in the FDA NDC Directory. 1 generic version is FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Sovaldi go generic?
September 2029 is the expected month, and that is probable but not certain. It is when Sovaldi’s patent 7,964,580 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to June 2031; a court ruling or a settlement can bring a generic sooner.
Will generic sofosbuvir be the same as Sovaldi?
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 Sovaldi?
Not yet. The FDA Orange Book lists no approved generic version of Sovaldi that is still marketed.
When does the Sovaldi patent expire?
The FDA Orange Book lists 9 patents for Sovaldi; the last runs to June 2031, counting a six-month pediatric extension. The one behind the expected month is patent 7,964,580, which ends in September 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 (September 2029) weighs all of that.
Has anyone challenged the Sovaldi patents?
Yes. The first patent challenge to Sovaldi reached the FDA in December 2017, from 2 companies on that first day. The FDA approved a first challenger’s generic in January 2022, 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.
Changes to This Projection
- First generic expected September 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
- MektoviBinimetinib2029 to 2031
- TryvioAprocitentan2035 to 2036
- GozellixGallium Ga-68 GozetotideJuly 2035
- ZolymbusBimatoprostJune 2036
- QuliptaAtogepant2038 to 2039
- CleviprexClevidipineTBD no date yet
About Sovaldi
- Generic name sofosbuvir
- How it is taken By mouth
- Company Gilead Sciences Inc
- Patent challenges Since December 2017 (FDA)
- More drugs Brand-name drugs starting with S
- Have a question? A pharmacist answers, free. Ask about Sovaldi
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, CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.