Details for New Drug Application (NDA): 213491
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NDA 213491 describes PROCYSBI, which is a drug marketed by Horizon and is included in two NDAs. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the PROCYSBI profile page.
The generic ingredient in PROCYSBI is cysteamine bitartrate. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.
The generic ingredient in PROCYSBI is cysteamine bitartrate. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.
Summary for 213491
| Tradename: | PROCYSBI |
| Applicant: | Horizon |
| Ingredient: | cysteamine bitartrate |
| Patents: | 12 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213491
Generic Entry Date for 213491*:
Constraining patent/regulatory exclusivity:
Dosage:
GRANULE, DELAYED RELEASE;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.
Pharmacology for NDA: 213491
| Mechanism of Action | Cystine Disulfide Reduction |
Suppliers and Packaging for NDA: 213491
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491 | NDA | Horizon Therapeutics USA, Inc. | 75987-140 | 75987-140-13 | 60 PACKET in 1 CARTON (75987-140-13) / 1 GRANULE, DELAYED RELEASE in 1 PACKET |
| PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491 | NDA | Horizon Therapeutics USA, Inc. | 75987-140 | 75987-140-14 | 120 PACKET in 1 CARTON (75987-140-14) / 1 GRANULE, DELAYED RELEASE in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE, DELAYED RELEASE;ORAL | Strength | EQ 75MG BASE/PACKET | ||||
| Approval Date: | Feb 14, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 22, 2024 | ||||||||
| Regulatory Exclusivity Use: | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) | ||||||||
| Regulatory Exclusivity Expiration: | Jun 22, 2025 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | 10,143,665*PED | Patent Expiration: | Feb 16, 2037 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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