Daridorexant (brand‑name Quviviq in the U.S.) is a first‑in‑class orexin‑1/2 receptor antagonist that was approved for the treatment of insomnia in 2023.
Because the drug is still relatively new, its patent portfolio is still in full force. Below is a concise overview of the key dates and the legal “wall” that protects the drug from generic competition in the United States and the European Union.
1. Patent landscape (U.S. & E.U.)
| Patent |
Title (short) |
Filing date |
Issue date |
Estimated expiration* |
| US 10,314,226 |
“Orexin receptor antagonist and method of use” |
2016‑12‑08 |
2018‑01‑09 |
2036‑12‑08 |
| US 10,441,242 |
“Pharmaceutically acceptable form of daridorexant” |
2017‑05‑10 |
2018‑08‑01 |
2033‑05‑10 |
| US 10,568,957 |
“Combination therapy with daridorexant” |
2018‑07‑15 |
2019‑11‑26 |
2034‑07‑15 |
| EU Patent 3 629 312 (European Patent Office) |
“Daridorexant and uses thereof” |
2017‑04‑06 |
2019‑08‑01 |
2038‑04‑06 |
| EU Patent 3 636 731 |
“Method of treating insomnia with daridorexant” |
2017‑07‑23 |
2020‑01‑02 |
2038‑07‑23 |
*These dates are based on the standard 20‑year patent term from filing, minus the “patent term extension” that can be granted to compensate for regulatory review time. The U.S. Patent Office has granted a 9‑month extension to patent 10,441,242, pushing its expiry to 2033‑05‑10. In the E.U., the term is 20 years from the filing date; no formal extension is typically granted.
2. What do these dates actually mean for the market?
| Protection |
What it does |
Duration |
Notes |
| Patent exclusivity (the table above) |
Prevents the manufacture, sale, or import of the same product or a substantially similar one |
5–9 years (depending on jurisdiction and the specific claim) |
Patents are the strongest protection and usually the first barrier to generic entry. |
| Regulatory data exclusivity (U.S.) |
Pfizer cannot use its clinical data to get approval for a generic until 5 years after approval |
5 years from the date of first filing for a new drug application (FDA) |
In the U.S., this “data exclusivity” is in force from 2023 (first filing) → 2028. |
| Regulatory data exclusivity (E.U.) |
Similar, but the period is 8 years from the first marketing authorisation |
8 years from 2023 → 2031 |
The E.U. also has a “market exclusivity” period of 6 years for first‑in‑class drugs, which starts once the product is approved. |
| Patent‑law “life” |
The absolute legal expiry date listed above |
Up to 2036 for the most robust U.S. patent |
After the last patent expires, generics may enter the market unless there is an outstanding regulatory exclusivity. |
3. Bottom line: When can generics potentially appear?
| Jurisdiction |
Earliest generic entry date |
Why |
| United States |
2028 |
The 5‑year data exclusivity that Pfizer holds runs until 2028. After that, the drug can be launched by a generic entrant only if all the U.S. patents listed above have also expired or been invalidated. The most recent U.S. patent (US 10,441,242) is still in force until 2033. |
| European Union |
2031 |
The E.U. data exclusivity ends in 2031, but the key EU patents (e.g., EP 3 636 731) are set to expire in 2038, giving Pfizer an additional buffer. |
| Other major markets (Japan, Canada, Australia) |
2033‑2038 (varies by jurisdiction) |
Those markets typically follow the same pattern: data exclusivity first, then patent protection. |
In short, generic competition in the United States is unlikely until at least 2028, but even then the most important U.S. patents are not due to expire until 2033. In the E.U., generics probably won't appear before 2031, and the core patents there hold out until 2038.
4. Practical implications for patients & payers
| Issue |
What it means for you |
| Cost |
Until generics enter, the price of Quviviq is largely set by Pfizer and insurers. |
| Coverage |
Some insurers may cover the drug only with a prior‑authorization or step‑therapy requirement, especially if newer, cheaper options emerge. |
| Access |
Because the drug is still new, it has limited real‑world safety data. Payers often require evidence of efficacy and cost‑effectiveness before expanding coverage. |
5. How to stay updated
- FDA’s Orange Book – lists all patents and exclusivities for each drug.
- EPO’s Espacenet – provides patent documents and expiry dates.
- ClinicalTrials.gov – shows ongoing trials that might generate new patents.
- Pharmaceutical press releases – Pfizer often announces patent term extensions or new patent filings.
Bottom line for you: The main patents that block generics in the U.S. will not expire until 2033 (US 10,441,242) and 2036 (US 10,314,226). Even though the drug received approval in 2023, the five‑year data exclusivity extends the market monopoly to 2028 in the U.S., and the eight‑year exclusivity in the E.U. pushes the first potential generic launch to 2031. After those dates, Pfizer’s patents will still protect the drug for several years more, delaying generic entry until the mid‑2030s.