Fanapt Generic: When Will Generic Iloperidone Be Available?

Fanapt’s Road to a Generic

Fanapt has had the market to itself since the FDA approved it in May 2009 (Vanda Pharmaceuticals Inc). Its FDA protection (new use) runs to April 2027. Its 11 listed patents run to December 2031. Generic companies have challenged its patents with the FDA since May 2013.

The first generic of Fanapt is expected in November 2027.

Why that month: patent 8,586,610, on a way of using it, ends then. That is about 4 years before the last listed patent runs out, in December 2031.

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.

Fanapt Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Fanapt’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 8,586,610, which ends in November 2027, the month the first generic is expected. Why the later ones may not hold it back

Source: FDA Orange Book, application 022192. Patent numbers open the patent on Google Patents.

Patent Challenges to Fanapt

The first patent challenge to Fanapt reached the FDA in May 2013, from one company on that first day. The FDA has not approved a first challenger’s generic yet.

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 Iloperidone

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.

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).

Fanapt Price: What Pharmacies Pay and What Generics Usually Do

What Medicare and Medicaid Spend on Fanapt

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.

Fanapt Strengths and Forms

Source: FDA Orange Book, Vanda Pharmaceuticals Inc. Listed for sale today by Vanda Pharmaceuticals Inc. (FDA NDC Directory).

Fanapt NDC Codes and Packages

Each Fanapt 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.

Source: the FDA NDC Directory, current listings only. Only packages sold under Fanapt’s own FDA approval (NDA 22192) are listed, never a generic. Some codes belong to companies that repackage Fanapt: it is the same medicine in a different package.

Changes to This Projection

• October 2026First 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.