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 | NA |
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 | NA |
Mar, 2042
(16 years from now) | Active |
| US12213982 | NA |
Sep, 2038
(12 years from now) | Active |
| US11752154 | NA |
Sep, 2038
(12 years from now) | Active |
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 Therap 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 |