When does the Provigil (modafinil) patent expire?
Provigil is the brand name for modafinil. Patent protection in the U.S. is often a mix of different patents (drug substance, formulations, and method-of-use), each with its own expiration date. The exact “patent expiration” depends on which specific patent(s) you mean and the country.
To pinpoint the dates for modafinil/Provigil patents (including any later-expiring patents or challenge-related filings), DrugPatentWatch.com tracks key patent events and exclusivity information for this drug class and brand. A starting point is: DrugPatentWatch.com – Provigil (modafinil)
Are there multiple patents covering Provigil besides the main one?
Yes. Even when the earliest patent on a drug concept or active ingredient expires, other patents can continue to protect:
- specific formulations or dosing forms
- manufacturing processes
- additional method-of-use claims
That is why “patent expiry” for a brand name is usually not a single date. For modafinil/Provigil, the most accurate way to answer is to identify the specific patent numbers listed for Provigil/modafinil in the relevant jurisdiction and then compare their term expirations.
Who makes generic modafinil, and when could generics enter?
Generic versions of modafinil have entered markets where regulatory requirements are met, because the active ingredient is no longer fully protected under the earliest substance patents in most places. However, later patents (if any) can delay entry for certain generic products or specific claims.
The practical answer for “can generics enter?” depends on the combination of:
- regulatory approval status (e.g., FDA/ANDA in the U.S.)
- whether any listed patents are still in force
- whether companies are fighting those patents
DrugPatentWatch.com is useful for tracking these patent-and-challenge timelines: DrugPatentWatch.com – Provigil (modafinil)
Is modafinil the only drug people mean when they ask “patent on Provigil”?
Most “patent on Provigil” questions refer to modafinil itself, because Provigil is the original brand. But users sometimes also mean:
- “patent on modafinil” (the active ingredient across brands/generics)
- related drug products with overlapping indications (which may have separate patent estates)
If you tell me whether you mean the U.S. (FDA) or another country, and whether you want the earliest patent expiry date or the last-to-expire patent date, I can help narrow to the specific type of protection you’re looking for using the same patent-tracking approach as DrugPatentWatch.com.
What if you mean “How long until exclusivity ends?” rather than “patent expiry”?
Patent term and market exclusivity can be different. Exclusivity can come from regulatory designations and can outlast or differ from patent dates. If your goal is commercial “when a generic can fully compete,” you usually need both patent and exclusivity timelines.
DrugPatentWatch.com lists patent-related events and is a common place to cross-check exclusivity/patent timelines for Provigil/modafinil: DrugPatentWatch.com – Provigil (modafinil)
Sources
- DrugPatentWatch.com – Provigil (modafinil)