NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 7 pharmaceutical companies such as BIOMARIN PHARM, ENDO OPERATIONS, DR REDDYS and others. It is marketed under 3 brand names, including KUVAN, SAPROPTERIN DIHYDROCHLORIDE, ZELVYSIA. Available in 3 different strengths, such as 100MG/PACKET, 500MG/PACKET, 100MG, and administered through 2 routes including POWDER;ORAL, TABLET;ORAL.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"105444","ingredient":"SAPROPTERIN DIHYDROCHLORIDE","trade_name":"KUVAN","family_id":"37aa11882dc2414ab124","publication_number":"USRE43797E","cleaned_patent_number":"RE43797","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-05-17","publication_date":"2012-11-06","legal_status":"Granted"} | USRE43797E1 | 06 Nov, 2012 | Granted | 17 May, 2025 | |
| {"application_id":"69267","ingredient":"SAPROPTERIN DIHYDROCHLORIDE","trade_name":"KUVAN","family_id":"db096af66d864afeaeb1","publication_number":"US7566714B2","cleaned_patent_number":"7566714","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-05-17","publication_date":"2009-07-28","legal_status":"Granted"} | US7566714B2 | 28 Jul, 2009 | Granted | 17 May, 2025 | |
| {"application_id":"69280","ingredient":"SAPROPTERIN DIHYDROCHLORIDE","trade_name":"KUVAN","family_id":"ac37c230f51b442fa135","publication_number":"US7612073B2","cleaned_patent_number":"7612073","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-05-17","publication_date":"2009-11-03","legal_status":"Granted"} | US7612073B2 | 03 Nov, 2009 | Granted | 17 May, 2025 | |
| {"application_id":"95537","ingredient":"SAPROPTERIN DIHYDROCHLORIDE","trade_name":"KUVAN","family_id":"b9dbaad6552048bd9a94","publication_number":"US7727987B2","cleaned_patent_number":"7727987","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-05-17","publication_date":"2010-06-01","legal_status":"Granted"} | US7727987B2 | 01 Jun, 2010 | Granted | 17 May, 2025 | |
| {"application_id":"69268","ingredient":"SAPROPTERIN DIHYDROCHLORIDE","trade_name":"KUVAN","family_id":"db096af66d864afeaeb1","publication_number":"US8067416B2","cleaned_patent_number":"8067416","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-05-17","publication_date":"2011-11-29","legal_status":"Granted"} | US8067416B2 | 29 Nov, 2011 | Granted | 17 May, 2025 | |
| {"application_id":"95551","ingredient":"SAPROPTERIN DIHYDROCHLORIDE","trade_name":"KUVAN","family_id":"b9dbaad6552048bd9a94","publication_number":"US8318745B2","cleaned_patent_number":"8318745","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-05-17","publication_date":"2012-11-27","legal_status":"Granted"} | US8318745B2 | 27 Nov, 2012 | Granted | 17 May, 2025 | |
| {"application_id":"69241","ingredient":"SAPROPTERIN DIHYDROCHLORIDE","trade_name":"KUVAN","family_id":"db096af66d864afeaeb1","publication_number":"US9433624B2","cleaned_patent_number":"9433624","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-05-17","publication_date":"2016-09-06","legal_status":"Granted"} | US9433624B2 | 06 Sep, 2016 | Granted | 17 May, 2025 | |
| {"application_id":"95533","ingredient":"SAPROPTERIN DIHYDROCHLORIDE","trade_name":"KUVAN","family_id":"1d68a4f6a85c4bd18b3f","publication_number":"US8003126B2","cleaned_patent_number":"8003126","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-05-16","publication_date":"2011-08-23","legal_status":"Granted"} | US8003126B2 | 23 Aug, 2011 | Granted | 16 May, 2026 | |
| {"application_id":"95517","ingredient":"SAPROPTERIN DIHYDROCHLORIDE","trade_name":"KUVAN","family_id":"1d68a4f6a85c4bd18b3f","publication_number":"US7566462B2","cleaned_patent_number":"7566462","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-05-16","publication_date":"2009-07-28","legal_status":"Patented case"} | US7566462B2 | 28 Jul, 2009 | Patented case | 16 May, 2026 | |
| {"application_id":"69275","ingredient":"SAPROPTERIN DIHYDROCHLORIDE","trade_name":"KUVAN","family_id":"2326507509e742f49ce5","publication_number":"US9216178B2","cleaned_patent_number":"9216178","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-05-01","publication_date":"2015-12-22","legal_status":"Granted"} | US9216178B2 | 22 Dec, 2015 | Granted | 01 May, 2033 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.