Sapropterin Powder for Oral Solution
- Brand(s)
- Kuvan
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Biomarin Pharmaceutical Inc. (2015-07-08)
- Oldest Current Product
- 2014-02-21
- License(s)
- NDA
- RxNORM
- POWDER FOR ORAL SOLUTION\SAPROPTERIN
- FDAOB
- ORAL\POWDER\SAPROPTERIN DIHYDROCHLORIDE
- SPL Active
- ORAL\POWDER, FOR SOLUTION\SAPROPTERIN DIHYDROCHLORIDE
- SPL Moiety
- ORAL\POWDER, FOR SOLUTION\SAPROPTERIN
product(s) by strength(s)
sapropterin dihydrochloride 100 mg powder for oral solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 681350301 | Kuvan | NDA | Biomarin Pharmaceutical Inc. | 2014-02-21 | SAPROPTERIN DIHYDROCHLORIDE | ORAL | POWDER, FOR SOLUTION | NDA205065 | af38711e-8873-4790-a92d-4d583e23fb89 |
sapropterin dihydrochloride 500 mg powder for oral solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 681350482 | Kuvan | NDA | Biomarin Pharmaceutical Inc. | 2015-05-27 | SAPROPTERIN DIHYDROCHLORIDE | ORAL | POWDER, FOR SOLUTION | NDA205065 | af38711e-8873-4790-a92d-4d583e23fb89 |
application(s)
| # | id | title | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|
| 1 | NDA205065 | KUVAN | BIOMARIN PHARMACEUTICAL INC | 2013-12-19 | p7566714, METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA p8067416, METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA p7612073, TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA DUE TO TETRA HYDROBIOPTERIN RESPONSIVE PHENYLKETONURIA. KUVAN SHOULD BE TAKEN ORALLY WITH FOOD TO INCREASE ABSORPTION pRE43797, KUVAN IS INDICATED TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA | NDA205065_001, NDA205065_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA205065_001 | RX | SAPROPTERIN DIHYDROCHLORIDE (100MG/PACKET) | ORAL | POWDER | True | 2013-12-19 | KUVAN |
| 2 | NDA205065_002 | RX | SAPROPTERIN DIHYDROCHLORIDE (500MG/PACKET) | ORAL | POWDER | False | 2015-10-27 | KUVAN |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p7566714 (view patent) | 2024-11-17 | NDA205065, NDA022181 | Sapropterin Oral Tablet |
| 2 | p7612073 (view patent) | 2024-11-17 | NDA205065, NDA022181 | Sapropterin Oral Tablet |
| 3 | p8067416 (view patent) | 2024-11-17 | NDA205065, NDA022181 | Sapropterin Oral Tablet |
| 4 | pRE43797 (view patent) | 2024-11-17 | NDA205065, NDA022181 | Sapropterin Oral Tablet |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | af38711e-8873-4790-a92d-4d583e23fb89 (view SPL) | These highlights do not include all the information needed to use KUVAN safely and effectively. See full prescribing information for KUVAN. KUVAN (sapropterin dihydrochloride) tablets, for oral useKUVAN (sapropterin dihydrochloride) powder, for oral solutionInitial U.S. Approval: 2007 | prescription | Human Prescription | Biomarin Pharmaceutical Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-07-08 | 35 | 681350301, 681350482, 681350300 | Sapropterin Oral Tablet |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII