Serving leading biopharmaceutical companies globally:
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Serving leading biopharmaceutical companies globally:
Generated: October 20, 2017
| Tradename: | 1 |
| Applicant: | 1 |
| Ingredient: | 1 |
| Patents: | 10 |
| Therapeutic Class: | Enzyme Replacements/Modifiers |
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
KUVAN |
sapropterin dihydrochloride |
TABLET;ORAL | 022181 | NDA | BioMarin Pharmaceutical Inc. | 68135-300 | 68135-300-02 | 120 TABLET in 1 BOTTLE (68135-300-02) |
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 13, 2007 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 23, 2017 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Oct 23, 2017 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | ► Subscribe | Patent Expiration: | May 16, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Serving leading 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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