Sephience is a drug owned by Ptc Therapeutics Inc. It is protected by 4 US drug patents filed in 2025 out of which none have expired yet. Sephience's patents will be open to challenges from 28 July, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 06, 2042. Details of Sephience'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. | |||
| US11072614 | Polymorphs Of Sepiapterin And Salts Thereof |
Apr, 2038
(12 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). | |||
| US12257252 | Compositions And Methods For Increasing Tetrahydrobiopterin Plasma Exposure |
Mar, 2042
(15 years from now) | Active |
| US11752154 | Pharmaceutical Compositions Comprising Sepiapterin And Uses Thereof |
Sep, 2038
(12 years from now) | Active |
| US12213982 | Pharmaceutical Compositions Comprising Sepiapterin And Uses Thereof |
Sep, 2038
(12 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 Sephience's patents.
Latest Legal Activities on Sephience's Patents
Given below is the list of recent legal activities going on the following patents of Sephience.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification | 17 Sep, 2025 | US12257252 |
| Mail Patent eCofC Notification | 16 Sep, 2025 | US12257252 |
| Patent eCofC Notification | 16 Sep, 2025 | US12257252 |
| Recordation of Patent eCertificate of Correction | 16 Sep, 2025 | US12257252 |
| Post Issue Communication - Certificate of Correction | 21 Aug, 2025 | US12257252 |
| Mail O.P. Petition Decision | 27 May, 2025 | US12213982 |
| Email Notification | 27 May, 2025 | US12213982 |
| Mail-Petition Decision - Dismissed | 23 May, 2025 | US12213982 |
| Petition Decision - Dismissed | 22 May, 2025 | US12213982 |
| O.P. Petition Decision | 21 May, 2025 | US12213982 |
FDA has granted several exclusivities to Sephience. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Sephience, 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
Sephience.
Exclusivity Information
Sephience holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Sephience's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 28, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Sephience 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 Sephience's family patents as well as insights into
ongoing legal events
on those patents.
Sephience's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sephience's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 06, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sephience Generics:
There are no approved generic versions for Sephience as of now.
About Sephience
Sephience is a drug owned by Ptc Therapeutics Inc. Sephience uses Sepiapterin as an active ingredient. Sephience was launched by Ptc in 2025.
Approval Date:
Sephience was approved by FDA for market use on 28 July, 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 Sephience is 28 July, 2025, its NCE-1 date is estimated to be 28 July, 2029.
Active Ingredient:
Sephience uses Sepiapterin as the active ingredient. Check out other Drugs and Companies using Sepiapterin ingredient
Dosage:
Sephience is available in powder form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG/PACKET | POWDER | Prescription | ORAL |
| 1GM/PACKET | POWDER | Prescription | ORAL |