Olysio Generic: When Will Generic Simeprevir 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
Olysio Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July 2027 About 10 months 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? September 2029 8 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 simeprevir sodium is expected to be available in July 2027, about 10 months away. None is for sale yet.
Why July 2027?
A patent that protects the brand runs out. After that, approved generics can be sold. We rate it probable: more likely than not, but it can still move.
If Olysio’s last patent runs to September 2029, how can a generic come sooner?
The patent that runs to September 2029 (8,148,399) covers 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. 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 Olysio 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.
Olysio 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 November 2013 FDA Orange Book
- Patents listed 8 last runs to September 2029 A generic is expected sooner, in July 2027. See why FDA Orange Book
Olysio’s Road to a Generic
Olysio has had the market to itself since the FDA approved it in November 2013 (Janssen Products LP). Its 8 listed patents run to September 2029 (7 already expired).
The first generic of Olysio is expected in July 2027.
Why that month: a patent that protects the brand runs out. After that, approved generics can be sold. That is about 2 years before the last listed patent runs out, in September 2029.
Why a Generic Can Come Before September 2029
The last listed patent runs to September 2029; 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.
Olysio Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Olysio’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 |
|---|---|---|---|
| 8,349,869 | The active ingredient; the product’s formulation; a way of using it (U-1467) | July 2026 | Expired |
| 8,741,926 | The active ingredient; a way of using it (U-1467) | July 2026 | Expired |
| 8,754,106 | The active ingredient; a way of using it (U-1467) | July 2026 | Expired |
| 9,040,562 | The active ingredient; the product’s formulation; a way of using it (U-1467) | July 2026 | Expired |
| 9,353,103 | A way of using it (U-1467) | July 2026 | Expired |
| 9,623,022 | A way of using it (U-1467) | July 2026 | Expired |
| 9,856,265 | The active ingredient; the product’s formulation; a way of using it (U-1467) | July 2026 | Expired |
| 8,148,399 | The active ingredient; the product’s formulation; a way of using it (U-1467) | September 2029 | Active |
Source: FDA Orange Book, application 205123. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Simeprevir Sodium
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 Olysio yet.
Approved by the FDA
Not yet. The FDA has not approved a generic simeprevir sodium. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic simeprevir sodium 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).
Olysio 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 Olysio, 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.
Olysio Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 150MG BASE | Capsule | Oral | November 2013 | Discontinued reference product |
Source: FDA Orange Book, Janssen Products LP.
What a Generic Olysio Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Olysio 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 Olysio”. 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 Olysio
Is there a generic for Olysio right now?
No. As of October 9, 2026 no generic simeprevir sodium is listed for sale in the FDA NDC Directory.
When will Olysio go generic?
July 2027 is the expected month, and that is probable but not certain. A patent that protects the brand runs out. After that, approved generics can be sold. The last listed patent runs to September 2029; a court ruling or a settlement can bring a generic sooner.
Will generic simeprevir sodium be the same as Olysio?
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 Olysio?
Not yet. The FDA Orange Book lists no approved generic version of Olysio.
When does the Olysio patent expire?
The FDA Orange Book lists 8 patents for Olysio; the last runs to 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 (July 2027) weighs all of that.
Changes to This Projection
- First generic expected July 2027 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
- CaprelsaVandetanibAugust 2028
- LymphoseekTechnetium TC-99M TilmanoceptJanuary 2029
- QbrexzaGlycopyrronium TosylateAugust 2030
- GiaprezaAngiotensin II Acetate2031 to 2032
- ZerbaxaCeftolozane and TazobactamFebruary 2036
- TrudhesaDihydroergotamine MesylateJanuary 2039
About Olysio
- Generic name simeprevir sodium
- How it is taken By mouth
- Company Janssen Products LP
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Olysio
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, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.