Biomarin Pharm Drug Patent Portfolio

Biomarin Pharm owns 2 orange book drugs protected by 28 US patents Given below is the list of Biomarin Pharm's drug patents along with their expiration dates.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US10646550 Use of C-type natriuretic peptide variants to treat skeletal dysplasia 01 Aug, 2036
Active
US11590204 Use of C-type natriuretic peptide variants to treat skeletal dysplasia 01 Aug, 2036
Active
US11911446 Use of C-type natriuretic peptide variants to treat skeletal dysplasia 01 Aug, 2036
Active
US9907834 Use of C-type natriuretic peptide variants to treat skeletal dysplasia 01 Aug, 2036
Active
US9216178 Dry blend formulation of tetrahydrobiopterin 01 May, 2033
Active
US9216178 Dry blend formulation of tetrahydrobiopterin 01 Nov, 2032
Active
US8198242 Variants of C-type natriuretic peptide 11 Jun, 2030
Active
USRE48267 Variants of C-type natriuretic peptide 20 May, 2030
Active
US7566462 Stable tablet formulation 16 May, 2026
Active
US8003126 Stable tablet formulation 16 May, 2026
Active
US7566462 Stable tablet formulation 16 Nov, 2025
Active
US8003126 Stable tablet formulation 16 Nov, 2025
Active
US7566714 Methods and compositions for the treatment of metabolic disorders 17 May, 2025
Active
US7612073 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring 17 May, 2025
Active
US7727987 Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride 17 May, 2025
Active
US7947681 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring 17 May, 2025
Active
US8067416 Methods and compositions for the treatment of metabolic disorders 17 May, 2025
Active
US8318745 Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride 17 May, 2025
Active
US9433624 Methods and compositions for the treatment of metabolic disorders 17 May, 2025
Active
USRE43797 Methods of administering tetrahydrobiopterin 17 May, 2025
Active
US7566714 Methods and compositions for the treatment of metabolic disorders 17 Nov, 2024
Active
US7612073 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring 17 Nov, 2024
Active
US7727987 Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride 17 Nov, 2024
Active
US7947681 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring 17 Nov, 2024
Active
US8067416 Methods and compositions for the treatment of metabolic disorders 17 Nov, 2024
Active
US8318745 Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride 17 Nov, 2024
Active
US9433624 Methods and compositions for the treatment of metabolic disorders 17 Nov, 2024
Active
USRE43797 Methods of administering tetrahydrobiopterin 17 Nov, 2024
Active


Given below is the list of recent legal activities going on the following drug patents of Biomarin Pharm.

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 29 Apr, 2024 US9433624 (Litigated)
transaction for FDA Determination of Regulatory Review Period 04 Mar, 2024 US8198242
transaction for FDA Determination of Regulatory Review Period 28 Feb, 2024 US8198242
Second letter to regulating agency to determine regulatory review period 05 Jan, 2024 US8198242
Payment of Maintenance Fee, 12th Year, Large Entity 21 Nov, 2023 US8198242
Payment of Maintenance Fee, 4th Year, Large Entity 19 Oct, 2023 US10646550
Letter from FDA or Dept of Agriculture re PTE application 28 Sep, 2023 US8198242
Payment of Maintenance Fee, 8th Year, Large Entity 23 May, 2023 US9216178
Payment of Maintenance Fee, 12th Year, Large Entity 20 Apr, 2023 US8067416
Payment of Maintenance Fee, 12th Year, Large Entity 20 Jan, 2023 US8003126 (Litigated)
Initial letter Re: PTE Application to regulating agency 03 Aug, 2022 US8198242
Payment of Maintenance Fee, 4th Year, Large Entity 07 Sep, 2021 US9907834
Payment of Maintenance Fee, 12th Year, Large Entity 03 May, 2021 US7612073 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 28 Jan, 2021 US7566714 (Litigated)
Post Issue Communication - Certificate of Correction 21 Jan, 2021 US10646550


Biomarin Pharm Drug Patents' Oppositions Filed in EPO

Biomarin Pharm drug patents have faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 17, 2013, by Generics [Uk] Limited. This opposition was filed on patent number EP08745614A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP18205446A Nov, 2022 Dipharma S.A. Granted and Under Opposition
EP18205446A Nov, 2022 Coripharma ehf. Granted and Under Opposition
EP18205446A Oct, 2022 betapharm Arzneimittel GmbH Granted and Under Opposition
EP16178739A Oct, 2022 Dipharma S.A. Granted and Under Opposition
EP16178739A Oct, 2022 TOBIO NOVELFARMA ILAC SAN. VE TIC. A.S. Granted and Under Opposition
EP18205446A Oct, 2022 SANDOZ AG Granted and Under Opposition
EP16178739A Oct, 2022 STADA Arzneimittel AG Granted and Under Opposition
EP18205446A Oct, 2022 STADA Arzneimittel AG Granted and Under Opposition
EP16192229A Sep, 2022 Ascendis Pharma Growth Disorders A/S Granted and Under Opposition
EP12005352A Sep, 2021 Coripharma ehf. Granted and Under Opposition
EP12005352A Sep, 2021 betapharm Arzneimittel GmbH Granted and Under Opposition
EP12005352A Sep, 2021 STADA Arzneimittel AG Granted and Under Opposition
EP12005352A Sep, 2021 Teva Pharmaceutical Industries Ltd. Granted and Under Opposition
EP12005352A Jul, 2021 Dipharma S.A. Granted and Under Opposition
EP04820966A Mar, 2020 Lederer & Keller Patentanwälte Partnerschaft mbB Opposition rejected
EP04819152A Apr, 2017 Teva Pharmaceutical Industries Ltd Revoked
EP04819152A Apr, 2017 Alfred E. Tiefenbacher (GmbH & Co. KG) Revoked
EP04819152A Apr, 2017 DIPHARMA S.A. Revoked
EP08745614A Jul, 2013 Generics [UK] Limited Revoked


Biomarin Pharm's Family Patents

Biomarin Pharm drugs have patent protection in a total of 30 countries. It's US patent count contributes only to 25.1% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree.

Family Patents



Biomarin Pharm Drug List

Given below is the complete list of Biomarin Pharm's drugs and the patents protecting them.


1. Kuvan

Kuvan is protected by 22 patents, out of which none have expired yet. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US9216178
(Pediatric)
Dry blend formulation of tetrahydrobiopterin 01 May, 2033
(8 years from now)
Active
US9216178 Dry blend formulation of tetrahydrobiopterin 01 Nov, 2032
(8 years from now)
Active
US7566462
(Pediatric)
Stable tablet formulation 16 May, 2026
(1 year, 7 months from now)
Active
US8003126
(Pediatric)
Stable tablet formulation 16 May, 2026
(1 year, 7 months from now)
Active
US7566462 Stable tablet formulation 16 Nov, 2025
(1 year, 1 month from now)
Active
US8003126 Stable tablet formulation 16 Nov, 2025
(1 year, 1 month from now)
Active
US7566714
(Pediatric)
Methods and compositions for the treatment of metabolic disorders 17 May, 2025
(7 months from now)
Active
US7612073
(Pediatric)
Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring 17 May, 2025
(7 months from now)
Active
US7727987
(Pediatric)
Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride 17 May, 2025
(7 months from now)
Active
US7947681
(Pediatric)
Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring 17 May, 2025
(7 months from now)
Active
US8067416
(Pediatric)
Methods and compositions for the treatment of metabolic disorders 17 May, 2025
(7 months from now)
Active
US8318745
(Pediatric)
Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride 17 May, 2025
(7 months from now)
Active
US9433624
(Pediatric)
Methods and compositions for the treatment of metabolic disorders 17 May, 2025
(7 months from now)
Active
USRE43797
(Pediatric)
Methods of administering tetrahydrobiopterin 17 May, 2025
(7 months from now)
Active
US7566714 Methods and compositions for the treatment of metabolic disorders 17 Nov, 2024
(a month from now)
Active
US7612073 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring 17 Nov, 2024
(a month from now)
Active
US7727987 Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride 17 Nov, 2024
(a month from now)
Active
US7947681 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring 17 Nov, 2024
(a month from now)
Active
US8067416 Methods and compositions for the treatment of metabolic disorders 17 Nov, 2024
(a month from now)
Active
US8318745 Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride 17 Nov, 2024
(a month from now)
Active
US9433624 Methods and compositions for the treatment of metabolic disorders 17 Nov, 2024
(a month from now)
Active
USRE43797 Methods of administering tetrahydrobiopterin 17 Nov, 2024
(a month from now)
Active

Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Kuvan's drug page


2. Voxzogo

Voxzogo is protected by 6 patents, out of which none have expired yet. Check out its patent list below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
US10646550 Use of C-type natriuretic peptide variants to treat skeletal dysplasia 01 Aug, 2036
(11 years from now)
Active
US11590204 Use of C-type natriuretic peptide variants to treat skeletal dysplasia 01 Aug, 2036
(11 years from now)
Active
US11911446 Use of C-type natriuretic peptide variants to treat skeletal dysplasia 01 Aug, 2036
(11 years from now)
Active
US9907834 Use of C-type natriuretic peptide variants to treat skeletal dysplasia 01 Aug, 2036
(11 years from now)
Active
US8198242 Variants of C-type natriuretic peptide 11 Jun, 2030
(5 years from now)
Active
USRE48267 Variants of C-type natriuretic peptide 20 May, 2030
(5 years from now)
Active

Discover which of these patents contain the active ingredient(API) of the drug, their family patents, along with litigation and legal activity details of these patents on Voxzogo's drug page


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