Zokinvy Generic: When Will Generic Lonafarnib Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Zokinvy Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? November 2027 About 13 months away Why then?
  2. Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
  3. When does the last patent end? July 2029 Its only patent listed with the FDA Why is a generic expected sooner?
  4. Can you buy a generic today? Not yet No company lists one for sale

Explains

PharmD, BCPS · Clinical pharmacist Updated

Generic lonafarnib is expected to be available in November 2027, about 13 months away. None is for sale yet.

Why November 2027?

It is when Zokinvy’s FDA protection for orphan drug ends. Seven years of protection for a use in a rare disease. We rate it probable: more likely than not, but it can still move.

If Zokinvy’s last patent runs to July 2029, how can a generic come sooner?

The patent that runs to July 2029 (7,838,531) covers a way of using it. 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

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 Zokinvy 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.

Zokinvy 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
None filed yet No filers on record
Brand sales
Sales not reported
  • FDA approved 2020 November 2020 FDA Orange Book
  • Patents listed 1 last runs to July 2029 A generic is expected sooner, in November 2027. See why FDA Orange Book

Zokinvy’s Road to a Generic

Zokinvy has had the market to itself since the FDA approved it in November 2020 (Sentynl Therapeutics Inc). Its FDA protection (orphan drug) runs to November 2027. Its one listed patent runs to July 2029.

The first generic of Zokinvy is expected in November 2027.

Why that month: FDA gives new drugs a protected period, for example for a rare-disease use. It ends then. That is about 1.5 years before the last listed patent runs out, in July 2029.

Brand alone on the market Since FDA approval, November 2020
Orphan drug Ends November 2027 The protection behind the expected month of generic availability
Patent 7,838,531 Expires July 2029
Brand alone on the market FDA exclusivity Patent on a use First generic expected Swipe the chart sideways to see every year.

Why a Generic Can Come Before July 2029

The last listed patent runs to July 2029, but it covers a way of using it, 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.

Zokinvy Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Zokinvy’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.

Patents listed with the FDA (1)
PatentWhat it coversProtects untilStatus
7,838,531 A way of using it (U-3070) July 2029 Active
FDA exclusivities (1)
ExclusivityWhat it meansEndsStatus
Orphan drug ODE-324Seven years of protection for a use in a rare disease.November 2027Active

Source: FDA Orange Book, application 213969. Patent numbers open the patent on Google Patents.

Who Is Lined Up to Make Generic Lonafarnib

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.

1

Applied to the FDA

No company is recorded as having applied to the FDA to make a generic Zokinvy yet.

2

Approved by the FDA

Not yet. The FDA has not approved a generic lonafarnib. Final approval often comes close to the day a generic can be sold.

3

For Sale in Pharmacies

Not yet. No company lists a generic lonafarnib 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).

Zokinvy 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 Zokinvy, 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.

Zokinvy Strengths and Forms

StrengthFormHow it is takenApprovedStatus
50MGCapsuleOralNovember 2020Prescription reference product
75MGCapsuleOralNovember 2020Prescription reference product

Source: FDA Orange Book, Sentynl Therapeutics Inc. Listed for sale today by Eiger BioPharmaceuticals, Inc. and Sentynl Therapeutics, Inc. (FDA NDC Directory).

Zokinvy NDC Codes and Packages

Each Zokinvy 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.

Zokinvy packages (4)
NDCProductPackageCompany
73079-0050-3050 mg capsulebottle of 30 capsulesEiger BioPharmaceuticals, Inc.
73079-0075-3075 mg capsulebottle of 30 capsulesEiger BioPharmaceuticals, Inc.
42358-0450-30LONAFARNIB 50 mg/1 capsulebottle of 30 capsulesSentynl Therapeutics, Inc.
42358-0475-30LONAFARNIB 75 mg/1 capsulebottle of 30 capsulesSentynl Therapeutics, Inc.

Source: the FDA NDC Directory, current listings only. Only packages sold under Zokinvy’s own FDA approval (NDA 213969) are listed, never a generic. Some codes belong to companies that repackage Zokinvy: it is the same medicine in a different package.

What a Generic Zokinvy Means for You

Nothing Changes Until It Is in Pharmacies

Until a generic is actually for sale, keep filling Zokinvy 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 Zokinvy”. 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 Zokinvy

Is there a generic for Zokinvy right now?

No. As of October 9, 2026 no generic lonafarnib is listed for sale in the FDA NDC Directory.

When will Zokinvy go generic?

November 2027 is the expected month, and that is probable but not certain. It is when Zokinvy’s FDA protection for orphan drug ends. Seven years of protection for a use in a rare disease. The last listed patent runs to July 2029, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.

Will generic lonafarnib be the same as Zokinvy?

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 Zokinvy?

Not yet. The FDA Orange Book lists no approved generic version of Zokinvy.

When does the Zokinvy patent expire?

One patent is listed for Zokinvy in the FDA Orange Book; it runs to 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 (November 2027) weighs all of that.

Changes to This Projection

  • First generic expected November 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

All upcoming generics

About Zokinvy

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.