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Details for New Drug Application (NDA): 203389
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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 Pharma Usa |
Ingredient: | cysteamine bitartrate |
Patents: | 10 |
Formulation / Manufacturing: | see details |
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 Pharma 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 Pharma 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: | Apr 30, 2020 | ||||||||
Regulatory Exclusivity Use: | MANAGEMENT OF NEPHROPATHIC CYSTINOSIS IN ADULTS AND CHILDREN AGES 6 YEARS AND OLDER. | ||||||||
Regulatory Exclusivity Expiration: | Feb 14, 2023 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Regulatory Exclusivity Expiration: | Jun 22, 2021 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY |
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