DrugPatentWatch Database Preview
KUVAN Drug Profile
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Which patents cover Kuvan, and when can generic versions of Kuvan launch?
This drug has eighty-five patent family members in twenty-four countries.
The generic ingredient in KUVAN is sapropterin dihydrochloride. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
Summary for KUVAN
| International Patents: | 85 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 40 |
| Patent Applications: | 63 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KUVAN |
| DailyMed Link: | KUVAN at DailyMed |
Pharmacology for KUVAN
Synonyms for KUVAN
| (-)-(6R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydro-4(3H)-pteridinone |
| (6beta)-5,6,7,8-Tetrahydro-L-biopterin dihydrochloride |
| (6R,1'R,2'S)-5,6,7,8 TETRAHYDROBIOPTERIN |
| (6R,S)-5,6,7,8-TETRAHYDRO-L-BIOPTERIN 2HCL |
| (6R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydro-4(1H)-pteridinone |
| (6R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride |
| (6R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydropteridin-4(1H)-one |
| (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-3,4,5,6,7,8-hexahydropteridin-4-one |
| (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-1H-pteridin-4-one |
| (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-1H-pteridin-4-one dihydrochloride |
| (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydropteridin-4(1H)-one |
| (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydropteridin-4(1H)-one dihydrochloride |
| (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydropteridin-4(3H)-one |
| (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydropteridin-4(3H)-one dihydrochloride |
| (6R)-5,6,7,8-TETRAHYDRO-L-BIOPTERIN |
| (6R)-5,6,7,8-Tetrahydro-L-biopterin 2HCl |
| (6R)-5,6,7,8-Tetrahydro-L-Biopterin Dihydrochloride |
| (6R)-5,6,7,8-Tetrahydrobiopterin |
| (6R)-5,6,7,8-Tetrahydrobiopterin dihydrochloride |
| (6R)-BH4 |
| (6r)-erythro-5,6,7,8-tet-rahydrobiopterin |
| (6R)-L-erythro-5,6,7,8-Tetrahydrobiopterin |
| (6R)-L-erythro-tetrahydrobiopterin |
| (6R)-Tetrahydrobiopterin |
| (6R)-tetrahydrobiopterin dihydrochloride |
| (6R)-Tetrahydrobiopterin hydrochloride |
| (R)-2-amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydropteridin-4(1H)-one |
| (R)-2-amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydropteridin-4(1H)-one dihydrochloride |
| (R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydropteridin-4(3H)-one dihydrochloride |
| (R)-2-Amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydropteridin-4(3H)-onedihydrochloride |
| 129443-84-1 |
| 2-Amino-6-(1,2-dihydroxypropyl)-5,6,7,8-tetrahydoro-4(1H)-pteridinone |
| 2-amino-6-(1,2-dihydroxypropyl)-5,6,7,8-tetrahydro-1H-pteridin-4-one |
| 2-Amino-6R-(1R,2S-dihydroxypropyl)-5,6,7,8-tetrahydro-4(1H)-pteridinone |
| 27070-47-9 |
| 4(1H)-Pteridinone, (6R)-2-amino-6-((1R,2S)-1,2-dihydroxypropyl)-5,6,7,8-tetrahydro- |
| 4(1H)-Pteridinone, 2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-, (6r)- |
| 4(1H)-Pteridinone, 5,6,7,8-tetrahydro-2-amino-6-(1,2-dihydroxypropyl)-, dihydrochloride, (6R-(6R*(1R*,2S*)))- |
| 4(1H)-Pteridinone,2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro |
| 5,6,7,8 Tetrahydrobiopterin |
| 5,6,7,8-tetra-H-biopterin |
| 5,6,7,8-tetrahydro-L-erythrobiopterin |
| 5,6,7,8-tetrahydrobiopterin |
| 5,6,7,8-tetrahydrodictyopterin |
| 56T388 |
| 62989-33-7 |
| 69056-38-8 |
| 69081654-1FB6-4B89-B9B9-823C9887EE36 |
| 6R-5,6,7,8-Tetrahydrobiopterin |
| 6R-BH4 |
| 6R-L-5,6,7,8-Tetrahydrobiopterin |
| 6R-L-erythro-5,6,7,8-tetrahydrobiopterin |
| 6R-Tetrahydrobiopterin |
| 7-tetrahydrobiopterin |
| 79493-88-2 |
| 90687-77-7 |
| AC1L2BG0 |
| AC1LCS48 |
| AJ-64209 |
| AJ-64210 |
| AK-93996 |
| AKOS030231420 |
| AN-37981 |
| ANW-53224 |
| AX8018900 |
| BCBcMAP01_000204 |
| BDBM50373697 |
| BH4 |
| Biobuden |
| BioMarin T 1401 |
| Biopten |
| Biopten (TN) |
| Biopterin, 5,6,7,8-tetrahydro- |
| Bipten |
| bmse000911 |
| BPH4 |
| C00272 |
| CAS-69056-38-8 |
| CHEBI:32120 |
| CHEBI:59560 |
| CHEMBL1201774 |
| CHEMBL1201775 |
| CHEMBL1515624 |
| CS-5740 |
| CTK8B6290 |
| D01798 |
| D08505 |
| D0F9XO |
| D0Q9YT |
| D0S2IQ |
| Dapropterin |
| Dapropterin dihydrochloride |
| DAPROTERIN |
| DB00360 |
| DSSTox_CID_20620 |
| DSSTox_GSID_40620 |
| DSSTox_RID_79515 |
| DTXSID0040620 |
| DTXSID1041138 |
| EGX657432I |
| FNKQXYHWGSIFBK-RPDRRWSUSA-N |
| FT-0653813 |
| FT-0674967 |
| FT-0700530 |
| GTPL5276 |
| HE023397 |
| HE119041 |
| HE330552 |
| HY-A0124A |
| KS-00001853 |
| Kuvan (TN) |
| L-erythro-tetrahydrobiopterin |
| MLS001332479 |
| MLS002153148 |
| MLS006010665 |
| MolPort-003-959-732 |
| NCGC00160393-01 |
| Phenoptin |
| phenylalanine hydroxylase cofactor |
| R-THBP |
| RG277LF5B3 |
| Sapropterin |
| Sapropterin (dihydrochloride) |
| Sapropterin (INN) |
| Sapropterin (TN) |
| Sapropterin [EMA EPAR] |
| Sapropterin [INN] |
| Sapropterin [MI] |
| Sapropterin [VANDF] |
| sapropterin 2HCl |
| Sapropterin DiHCl |
| Sapropterin dihydrochloride |
| Sapropterin dihydrochloride (USAN) |
| Sapropterin dihydrochloride [USAN] |
| Sapropterin HCl |
| SAPROPTERIN HYDROCHLORIDE |
| Sapropterin hydrochloride (JAN) |
| Sapropterina |
| Sapropterina [INN-Spanish] |
| Sapropterinum |
| Sapropterinum [INN-Latin] |
| SCHEMBL1070420 |
| SCHEMBL258544 |
| SCHEMBL258963 |
| Shiratori SN 0588 |
| SMP1_000285 |
| SMR000326922 |
| SMR004701650 |
| SUN 0588 |
| SUN-0588 |
| SUN-0588 (SHIRATORI) |
| T-1401 |
| T-1401 (Biomarin) |
| T1401 (BIOMARIN) |
| tetra-H-biopterin |
| tetra-hydro-biopterin |
| tetrahydro-6-biopterin |
| tetrahydro-l-biopterin |
| tetrahydrobiopterin |
| tetrahydrobiopterin (THB) |
| Tetrahydrobiopterin [WHO-DD] |
| Tetrahydrobiopterin dihydrochloride |
| THB |
| Tox21_111782 |
| UNII-EGX657432I |
| UNII-RG277LF5B3 |
| W-203341 |
| W-203533 |
| ZINC13585233 |
US Patents and Regulatory Information for KUVAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-001 | Dec 19, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181-001 | Dec 13, 2007 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-002 | Oct 27, 2015 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-001 | Dec 19, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Paragraph IV (Patent) Challenges for KUVAN
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Powder for Oral Solution | 500 mg/packet | ➤ Subscribe | 2016-12-20 |
| ➤ Subscribe | Powder for Oral Solution | 100 mg per packet | ➤ Subscribe | 2015-11-09 |
| ➤ Subscribe | Tablets | 100 mg | ➤ Subscribe | 2014-05-30 |
Non-Orange Book US Patents for KUVAN
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,344,139 | Process for preparing crystalline polymorphic forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride | ➤ Sign Up |
| 7,475,360 | Method for dynamically providing scroll indicators | ➤ Sign Up |
| 8,324,210 | Pterin analogs | ➤ Sign Up |
| 7,601,717 | Pterin analogs | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for KUVAN
| Country | Document Number | Estimated Expiration |
|---|---|---|
| South Korea | 101721198 | ➤ Sign Up |
| South Korea | 20100016445 | ➤ Sign Up |
| Mexico | 2007005039 | ➤ Sign Up |
| South Korea | 20150080026 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
