Daybue Stix is a drug owned by Acadia Pharmaceuticals Inc. It is protected by 4 US drug patents filed in 2026 out of which none have expired yet. Daybue Stix's patents will be open to challenges from 11 March, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 12, 2042. Details of Daybue Stix's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US12492167 | NA |
Jul, 2042
(16 years from now) | Active |
| US11827600 | Crystalline forms of trofinetide |
Jul, 2042
(16 years from now) | Active |
| US11370755 | Compositions of trofinetide |
Aug, 2040
(14 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9212204 | Treatment of rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid |
Jan, 2032
(5 years from now) | Active |
FDA has granted several exclusivities to Daybue Stix. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Daybue Stix, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Daybue Stix.
Exclusivity Information
Daybue Stix holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Daybue Stix's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 10, 2028 |
| ODE*(ODE*) | Mar 10, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Daybue Stix is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Daybue Stix's family patents as well as insights into
ongoing legal events
on those patents.
Daybue Stix's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Daybue Stix's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 12, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Daybue Stix Generics:
There are no approved generic versions for Daybue Stix as of now.
Alternative Brands for Daybue Stix
There are several other brand drugs in the same treatment category and using the same active ingredient (Trofinetide) as Daybue Stix. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Acadia Pharms Inc |
| |||
About Daybue Stix
Daybue Stix is a drug owned by Acadia Pharmaceuticals Inc. Daybue Stix uses Trofinetide as an active ingredient. Daybue Stix was launched by Acadia in 2025.
Approval Date:
Daybue Stix was approved by FDA for market use on 11 December, 2025.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Daybue Stix is 11 December, 2025, its NCE-1 date is estimated to be 11 March, 2027.
Active Ingredient:
Daybue Stix uses Trofinetide as the active ingredient. Check out other Drugs and Companies using Trofinetide ingredient
Dosage:
Daybue Stix is available in for solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 6000MG/PACKET | FOR SOLUTION | Prescription | ORAL |
| 5000MG/PACKET | FOR SOLUTION | Prescription | ORAL |
| 8000MG/PACKET | FOR SOLUTION | Prescription | ORAL |