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Details for New Drug Application (NDA): 203389
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NDA 203389 describes PROCYSBI, which is a drug marketed by Horizon Pharma Usa and is included in two NDAs. There are sixteen 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. One supplier is 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. One supplier is 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: | 11 |
| Formulation / Manufacturing: | see details |
Paragraph IV (Patent) Challenges for 203389
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PROCYSBI | CAPSULE, DELAYED RELEASE;ORAL | cysteamine bitartrate | 203389 | 2020-05-11 |
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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