Serving 500+ biopharmaceutical companies globally:
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Serving 500+ biopharmaceutical companies globally:
Generated: September 22, 2017
| Tradename: | 1 |
| Applicant: | 1 |
| Ingredient: | 1 |
| Patents: | 5 |
| Therapeutic Class: | Enzyme Replacements/Modifiers |
| Formulation / Manufacturing: | see details |
| Mechanism of Action | Cystine Disulfide Reduction |
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
PROCYSBI |
cysteamine bitartrate |
CAPSULE, DELAYED RELEASE;ORAL | 203389 | NDA | Raptor Therapeutics Inc. | 49663-001 | 49663-001-06 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (49663-001-06) |
PROCYSBI |
cysteamine bitartrate |
CAPSULE, DELAYED RELEASE;ORAL | 203389 | NDA | Raptor Therapeutics Inc. | 49663-002 | 49663-002-25 | 250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (49663-002-25) |
| 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: | Aug 14, 2018 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Apr 30, 2020 | ||||||||
| Regulatory Exclusivity Use: | ORPHAN DRUG EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Aug 14, 2022 | ||||||||
| Regulatory Exclusivity Use: | ORPHAN DRUG EXCLUSIVITY | ||||||||
Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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