Details for New Drug Application (NDA): 219666
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NDA 219666 describes SEPHIENCE, which is a drug marketed by Ptc Therap and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the SEPHIENCE profile page.
The generic ingredient in SEPHIENCE is sepiapterin. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the sepiapterin profile page.
The generic ingredient in SEPHIENCE is sepiapterin. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the sepiapterin profile page.
Summary for 219666
| Tradename: | SEPHIENCE |
| Applicant: | Ptc Therap |
| Ingredient: | sepiapterin |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219666
Generic Entry Date for 219666*:
Constraining patent/regulatory exclusivity:
TREATMENT OF HYPERPHENYLALANINEMIA (HPA) IN ADULT AND PEDIATRIC PATIENTS 1 MONTH OF AGE AND OLDER WITH SEPIAPTERIN-RESPONSIVE PHENYLKETONURIA (PKU) (TO BE USED IN CONJUNCTION WITH A PHENYLALANINE (PHE) - RESTRICTED DIET) Dosage:
POWDER;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 219666
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SEPHIENCE | sepiapterin | POWDER;ORAL | 219666 | NDA | PTC Therapeutics Inc. | 52856-201 | 52856-201-03 | 30 PACKET in 1 CARTON (52856-201-03) / 1 POWDER in 1 PACKET (52856-201-01) |
| SEPHIENCE | sepiapterin | POWDER;ORAL | 219666 | NDA | PTC Therapeutics Inc. | 52856-301 | 52856-301-03 | 30 PACKET in 1 CARTON (52856-301-03) / 1 POWDER in 1 PACKET (52856-301-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | 250MG/PACKET | ||||
| Approval Date: | Jul 28, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 28, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jul 28, 2032 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF HYPERPHENYLALANINEMIA (HPA) IN ADULT AND PEDIATRIC PATIENTS 1 MONTH OF AGE AND OLDER WITH SEPIAPTERIN-RESPONSIVE PHENYLKETONURIA (PKU) (TO BE USED IN CONJUNCTION WITH A PHENYLALANINE (PHE) - RESTRICTED DIET) | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 16, 2038 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF HYPERPHENYLALANINEMIA (HPA) IN ADULT AND PEDIATRIC PATIENTS WITH SEPIAPTERIN-RESPONSIVE PHENYLKETONURIA (PKU) BY ADMINISTERING SEPIAPTERIN | ||||||||
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