Pharsight

Kuvan is owned by Biomarin Pharm.

Kuvan contains Sapropterin Dihydrochloride.

Kuvan has a total of 20 drug patents out of which 0 drug patents have expired.

Kuvan was authorised for market use on 19 December, 2013.

Kuvan is available in powder;oral dosage forms.

Kuvan can be used as to reduce blood phenylalanine (phe) levels in patients with hyperphenylalaninemia (hpa), for reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia, method of use for reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia, 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.

The generics of Kuvan are possible to be released after 01 May, 2033.

Application	Filing Date	Opposition Party	Legal Status
EP18205446A	2022-11-09	Dipharma S.A.	Granted and Under Opposition
EP18205446A	2022-11-09	Coripharma ehf.	Granted and Under Opposition
EP18205446A	2022-10-28	betapharm Arzneimittel GmbH	Granted and Under Opposition
EP16178739A	2022-10-26	Dipharma S.A.	Granted and Under Opposition
EP18205446A	2022-10-12	SANDOZ AG	Granted and Under Opposition
EP16178739A	2022-10-12	TOBIO NOVELFARMA ILAC SAN. VE TIC. A.S.	Granted and Under Opposition
EP16178739A	2022-10-06	STADA Arzneimittel AG	Granted and Under Opposition
EP18205446A	2022-10-05	STADA Arzneimittel AG	Granted and Under Opposition
EP12005352A	2021-09-16	Coripharma ehf.	Granted and Under Opposition
EP12005352A	2021-09-15	betapharm Arzneimittel GmbH	Granted and Under Opposition
EP12005352A	2021-09-14	Teva Pharmaceutical Industries Ltd.	Granted and Under Opposition
EP12005352A	2021-09-14	STADA Arzneimittel AG	Granted and Under Opposition
EP12005352A	2021-07-13	Dipharma S.A.	Granted and Under Opposition
EP04820966A	2020-03-11	Lederer & Keller Patentanwälte Partnerschaft mbB	Opposition rejected
EP04819152A	2017-04-20	Alfred E. Tiefenbacher (GmbH & Co. KG)	Revoked
EP04819152A	2017-04-20	DIPHARMA S.A.	Revoked
EP04819152A	2017-04-20	Teva Pharmaceutical Industries Ltd	Revoked
EP08745614A	2013-07-17	Generics [UK] Limited	Revoked

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8067416	BIOMARIN PHARM	Methods and compositions for the treatment of metabolic disorders	Nov, 2024 (1 year, 7 months from now)
US7566714	BIOMARIN PHARM	Methods and compositions for the treatment of metabolic disorders	Nov, 2024 (1 year, 7 months from now)
USRE43797	BIOMARIN PHARM	Methods of administering tetrahydrobiopterin	Nov, 2024 (1 year, 7 months from now)
US9433624	BIOMARIN PHARM	Methods and compositions for the treatment of metabolic disorders	Nov, 2024 (1 year, 7 months from now)
US7612073	BIOMARIN PHARM	Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring	Nov, 2024 (1 year, 7 months from now)
US8318745	BIOMARIN PHARM	Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride	Nov, 2024 (1 year, 7 months from now)
US7727987	BIOMARIN PHARM	Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride	Nov, 2024 (1 year, 7 months from now)
US8067416 (Pediatric)	BIOMARIN PHARM	Methods and compositions for the treatment of metabolic disorders	May, 2025 (2 years from now)
US7612073 (Pediatric)	BIOMARIN PHARM	Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring	May, 2025 (2 years from now)
US7727987 (Pediatric)	BIOMARIN PHARM	Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride	May, 2025 (2 years from now)
USRE43797 (Pediatric)	BIOMARIN PHARM	Methods of administering tetrahydrobiopterin	May, 2025 (2 years from now)
US7566714 (Pediatric)	BIOMARIN PHARM	Methods and compositions for the treatment of metabolic disorders	May, 2025 (2 years from now)
US8318745 (Pediatric)	BIOMARIN PHARM	Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride	May, 2025 (2 years from now)
US9433624 (Pediatric)	BIOMARIN PHARM	Methods and compositions for the treatment of metabolic disorders	May, 2025 (2 years from now)
US7566462	BIOMARIN PHARM	Stable tablet formulation	Nov, 2025 (2 years from now)
US8003126	BIOMARIN PHARM	Stable tablet formulation	Nov, 2025 (2 years from now)
US7566462 (Pediatric)	BIOMARIN PHARM	Stable tablet formulation	May, 2026 (3 years from now)
US8003126 (Pediatric)	BIOMARIN PHARM	Stable tablet formulation	May, 2026 (3 years from now)
US9216178	BIOMARIN PHARM	Dry blend formulation of tetrahydrobiopterin	Nov, 2032 (9 years from now)
US9216178 (Pediatric)	BIOMARIN PHARM	Dry blend formulation of tetrahydrobiopterin	May, 2033 (10 years from now)

Drugs and Companies using SAPROPTERIN DIHYDROCHLORIDE ingredient

Market Authorisation Date: 19 December, 2013

Treatment: For reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia; To reduce blood phenylalanine (phe) levels in patients with hyperphenylalaninemia (hpa); Method of use for reducing blood phenylalanine levels in a human suffering from hyperphenylalaninemia; 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

Dosage: POWDER;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mg	05 Jun, 2014	1	10 May, 2019	16 Nov, 2025	Eligible
100 mg per packet	09 Nov, 2015	1	20 Aug, 2019	17 May, 2025	Eligible Deferred
500 mg per packet	23 Feb, 2017	1	20 Aug, 2019	01 Nov, 2032	Eligible