When these drugs can have a generic

Why the compound patent is not the answer

A brand lists every patent it believes reads on the product, not only the one claiming the molecule: how the solution is formulated, how the pen delivers it, what the drug is used for. A generic applicant must say something about each — that it has expired, that it is invalid, or that the generic does not infringe it — and the answer to the last listed patent is what decides when a copy can be sold, not the first. Wegovy carries nineteen; Mounjaro, twenty-nine.

Exclusivity runs separately and is not a patent at all. It is a period during which FDA may not approve somebody else's application, whatever the patents say. The Orange Book prints it as a letter code and a date; the durations FDA attaches to each kind are these:

• New Chemical Entity (NCE) — 5 years
• New Clinical Investigation — 3 years
• Orphan Drug (ODE) — 7 years
• Pediatric (PED) — 6 months added to existing patents and exclusivity
• Patent Challenge (PC) — 180 days, for generic applicants only

The letter codes above the dates are the Orange Book's own. They are printed here unchanged rather than glossed: each identifies a specific approval in FDA's records, and guessing at which would be inventing a fact.

What this does not tell you

Not a launch date. A patent can be litigated, settled around or designed around, and settlements between a brand and a first filer routinely set an entry date years before the last patent expires and years after the first. Not a price either: liraglutide has had approved generics since December 2024, and what that has done to what a patient pays is a question for the price pages and not for a patent table. And a compounded copy is not a generic — it is not an approved product at all, which is a separate record.

Where these come from

The Orange Book's data files, read in full rather than through a summary, and the approval register behind every date on them.

• Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book), FDA — Every listed patent, every exclusivity period and every approved generic, published by FDA as data files the printed edition is generated from.
• Drugs@FDA: FDA-approved drugs — What is approved, for which indication, and when — the register behind every approval date here.

Questions

When will tirzepatide become generic?

Not on one date. Tirzepatide's drug-substance patent — the one claiming the molecule — runs to 13 May 2036, its five-year new-chemical-entity exclusivity to 13 May 2027, and Lilly has listed patents on the two brands running to 2039 and 2041. A generic applicant has to clear or beat the ones that read on the product it copies, so the first tirzepatide generic depends on which patents are litigated and how, not on a single expiry.

Semaglutide's patent expired. Why is there no generic?

Because the compound patent is one of sixteen. US 8,536,122, which claims semaglutide itself, expired on 20 March 2026. Novo has fifteen more listed against Ozempic — formulation, device and method patents running to February 2041 — and four exclusivity periods against Wegovy running to 2029. Any of them can support an infringement case against a copy, which is why an expired compound patent has produced no US generic semaglutide.

Is there a generic for any of these drugs already?

Yes, for two. Liraglutide — the molecule in Victoza and Saxenda — has eleven approved generic applications from nine firms, the first approved on 23 December 2024. Phentermine and topiramate, the combination in Qsymia, has two, the first approved on 25 June 2024. An approval is not a shelf: whether a pharmacy stocks it, and at what price, is a separate question this site tracks on the cost pages.

Does compounded semaglutide count as a generic?

No, and the distinction matters legally and clinically. A generic is an approved copy that FDA has found bioequivalent to the brand. A compounded preparation is made by a pharmacy under a different part of the law, is not FDA-approved, and has not been evaluated for the same things. Where this site lists a compounded product, it says so on the card.

Where do these dates come from?

The FDA Orange Book's own data files — products, patent and exclusivity — read on 2026-09-12. Delisted patents are excluded. Nothing here is a forecast: a patent can be litigated, settled around or designed around, and none of these dates is a promise about what a pharmacy will stock.