Details for New Drug Application (NDA): 203389
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NDA 203389 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 203389
| Tradename: | PROCYSBI |
| Applicant: | Horizon |
| Ingredient: | cysteamine bitartrate |
| Patents: | 12 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203389
Generic Entry Date for 203389*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, 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: 203389
| Mechanism of Action | Cystine Disulfide Reduction |
Suppliers and Packaging for NDA: 203389
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389 | NDA | Horizon Therapeutics USA, Inc. | 75987-100 | 75987-100-04 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-100-04) |
| PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389 | NDA | Horizon Therapeutics USA, Inc. | 75987-101 | 75987-101-08 | 250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-101-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Apr 30, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 22, 2025 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Dec 22, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF NEPHROPATHIC CYSTINOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE TO LESS THAN 2 YEARS OF AGE | ||||||||
| Patent: | 10,143,665*PED | Patent Expiration: | Feb 16, 2037 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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