Daybue is a drug owned by Acadia Pharmaceuticals Inc. It is protected by 3 US drug patents filed from 2023 to 2024 out of which none have expired yet. Daybue'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'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. | |||
| US11827600 | Crystalline forms of trofinetide |
Jul, 2042
(17 years from now) | Active |
| US11370755 | Compositions of trofinetide |
Aug, 2040
(15 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
(6 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Daybue's patents.
Latest Legal Activities on Daybue's Patents
Given below is the list of recent legal activities going on the following patents of Daybue.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 03 Apr, 2024 | US9212204 |
| Letter from FDA or Dept of Agriculture re PTE application | 24 Jan, 2024 | US9212204 |
| Initial letter Re: PTE Application to regulating agency | 24 Aug, 2023 | US9212204 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 May, 2023 | US9212204 |
| Patent Term Extension Application under 35 USC 156 Filed | 04 May, 2023 | US9212204 |
| Patent Issue Date Used in PTA Calculation Critical | 28 Jun, 2022 | US11370755 |
| Recordation of Patent Grant Mailed Critical | 28 Jun, 2022 | US11370755 |
| Email Notification Critical | 09 Jun, 2022 | US11370755 |
| Issue Notification Mailed Critical | 08 Jun, 2022 | US11370755 |
| Dispatch to FDC | 25 May, 2022 | US11370755 |
FDA has granted several exclusivities to Daybue. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Daybue, 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.
Exclusivity Information
Daybue holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Daybue's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 10, 2028 |
| Orphan Drug Exclusivity(ODE-425) | Mar 10, 2030 |
US patents provide insights into the exclusivity only within the United States, but Daybue 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's family patents as well as insights into ongoing legal events on those patents.
Daybue's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Daybue'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 Generics:
There are no approved generic versions for Daybue as of now.
About Daybue
Daybue is a drug owned by Acadia Pharmaceuticals Inc. It is used for treating Rett Syndrome or its symptoms. Daybue uses Trofinetide as an active ingredient. Daybue was launched by Acadia Pharms Inc in 2023.
Approval Date:
Daybue was approved by FDA for market use on 10 March, 2023.
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 is 10 March, 2023, its NCE-1 date is estimated to be 11 March, 2027.
Active Ingredient:
Daybue uses Trofinetide as the active ingredient. Check out other Drugs and Companies using Trofinetide ingredient
Treatment:
Daybue is used for treating Rett Syndrome or its symptoms.
Dosage:
Daybue is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG/ML | SOLUTION | Prescription | ORAL |