Edurant Ped Generic: When Will Generic Rilpivirine 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
Edurant Ped Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? September 2027 About 11 months away Why then?
- Has the FDA approved a generic? January 2026 2 companies approved
- When does the last patent end? October 2037 Its only patent listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Yes 2 companies list one
It already is. A generic rilpivirine hydrochloride is listed for sale by 2 companies, so ask your pharmacy whether it can fill your prescription with one.
Why September 2027?
It is when Edurant Ped’s FDA protection for pediatric ends. Six more months, earned by studying the medicine in children. We rate it probable: more likely than not, but it can still move.
If Edurant Ped’s last patent runs to October 2037, how can a generic come sooner?
The patent that runs to October 2037 (11,065,198) covers the product’s formulation. 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. That is why the expected month comes before the last protection ends. See the road to a generic
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Edurant Ped, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Edurant Ped by the Numbers
- Reason
- FDA exclusivity endsFDA gives new drugs a protected period, for example for a rare-disease use. It ends then.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Low 1 company has filed, 1 first in line
- Brand sales
- Sales not reported
- FDA approved 2024 March 2024 FDA Orange Book
- Patents listed 1 last runs to October 2037 FDA Orange Book
- Generics FDA-approved 2 companies, the first approved January 2026 FDA Orange Book
Edurant Ped’s Road to a Generic
Edurant Ped has had the market to itself since the FDA approved it in March 2024 (Janssen Products LP). Its FDA protection (pediatric) runs to September 2027. Its one listed patent runs to October 2037.
The first generic of Edurant Ped is expected in September 2027.
Why that month: FDA gives new drugs a protected period, for example for a rare-disease use. It ends then. That is about 10 years before the last listed patent runs out, in October 2037.
Why a Generic Can Come Before October 2037
The last listed patent runs to October 2037, but it covers the product’s formulation, 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.
Edurant Ped Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Edurant Ped’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 |
|---|---|---|---|
| 11,065,198 | The product’s formulation | October 2037 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | March 2027 | Active |
| Pediatric PED | Six more months, earned by studying the medicine in children. | September 2027 | Active |
Source: FDA Orange Book, application 219016. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Rilpivirine Hydrochloride
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
At least 2 companies have applied to the FDA to make generic rilpivirine hydrochloride.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Approved by the FDA
The FDA has approved generic versions from 2 companies, the first in January 2026. 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
Yes. A generic rilpivirine hydrochloride is listed for sale by 2 companies. Ask your pharmacy whether it can fill your prescription with it.
Laurus Labs Limited and Somerset Therapeutics, LLC
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Somerset Therapeutics LLC | January 2026 | EQ 25MG BASE | AB |
| Laurus Labs Ltd | July 2026 | EQ 25MG BASE | AB |
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).
Edurant Ped 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 Edurant Ped, 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.
Edurant Ped Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 2.5MG BASE | Tablet, for suspension | Oral | March 2024 | Prescription reference product |
Source: FDA Orange Book, Janssen Products LP. Listed for sale today by Janssen Products, LP (FDA NDC Directory).
Edurant Ped NDC Codes and Packages
Each Edurant Ped 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 |
|---|---|---|---|
| 59676-0280-90 | RILPIVIRINE HYDROCHLORIDE 2.5 mg/1 tablet, for suspension | carton of 9 blister packs of 10 tablets | Janssen Products, LP |
Source: the FDA NDC Directory, current listings only. Only packages sold under Edurant Ped’s own FDA approval (NDA 219016) are listed, never a generic. Some codes belong to companies that repackage Edurant Ped: it is the same medicine in a different package.
What a Generic Edurant Ped Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Edurant Ped
Is there a generic for Edurant Ped right now?
Yes. The FDA NDC Directory lists a generic rilpivirine hydrochloride from 2 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Edurant Ped go generic?
It already has. The FDA NDC Directory lists a generic rilpivirine hydrochloride from 2 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic rilpivirine hydrochloride be the same as Edurant Ped?
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. At least 2 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. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Edurant Ped?
Yes. The FDA Orange Book lists approved generic versions from 2 companies, the first approved in January 2026: Somerset Therapeutics LLC and Laurus Labs 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 Edurant Ped patent expire?
One patent is listed for Edurant Ped in the FDA Orange Book; it runs to October 2037. 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 2027) weighs all of that.
Changes to This Projection
- First generic expected September 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
- TriumeqAbacavir Sulfate, Dolutegravir Sodium, and LamivudineDuring 2028
- LynparzaOlaparib2029 to 2030
- QelbreeViloxazine Hydrochloride2031 to 2032
- GenvoyaCobicistat, Elvitegravir, Emtricitabine, and Tenofovir Alafenamide FumarateDuring 2032
- ZeposiaOzanimod Hydrochloride2033 to 2034
- CamzyosMavacamtenApril 2036
About Edurant Ped
- Generic name rilpivirine hydrochloride
- How it is taken By mouth
- Company Janssen Products LP
- More drugs Brand-name drugs starting with E
- Have a question? A pharmacist answers, free. Ask about Edurant Ped
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.