Biomarin Drug Patent Portfolio
Biomarin owns 2 orange book drugs protected by 30 US patents Given below is the list of Biomarin's drug patents along with their expiration dates.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US12233106 | C-type natriuretic peptide variants to treat skeletal dysplasia in children | 11 Jul, 2042 | Active |
| 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 |
| US12514906 | 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 | Expired |
| US8003126 | Stable tablet formulation | 16 Nov, 2025 | Expired |
| US7566714 | Methods and compositions for the treatment of metabolic disorders | 17 May, 2025 | Expired |
| US7612073 | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring | 17 May, 2025 | Expired |
| US7727987 | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride | 17 May, 2025 | Expired |
| US7947681 | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring | 17 May, 2025 | Expired |
| US8067416 | Methods and compositions for the treatment of metabolic disorders | 17 May, 2025 | Expired |
| US8318745 | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride | 17 May, 2025 | Expired |
| US9433624 | Methods and compositions for the treatment of metabolic disorders | 17 May, 2025 | Expired |
| USRE43797 | Methods of administering tetrahydrobiopterin | 17 May, 2025 | Expired |
| US7566714 | Methods and compositions for the treatment of metabolic disorders | 17 Nov, 2024 | Expired |
| US7612073 | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring | 17 Nov, 2024 | Expired |
| US7727987 | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride | 17 Nov, 2024 | Expired |
| US7947681 | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring | 17 Nov, 2024 | Expired |
| US8067416 | Methods and compositions for the treatment of metabolic disorders | 17 Nov, 2024 | Expired |
| US8318745 | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride | 17 Nov, 2024 | Expired |
| US9433624 | Methods and compositions for the treatment of metabolic disorders | 17 Nov, 2024 | Expired |
| USRE43797 | Methods of administering tetrahydrobiopterin | 17 Nov, 2024 | Expired |
Latest Legal Activities on Biomarin's Drug Patents
Given below is the list of recent legal activities going on the following drug patents of Biomarin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Sequence Forwarded to Pubs on Tape | 10 Sep, 2025 | US12514906 |
| Mail Notice of Allowance | 03 Sep, 2025 | US12514906 |
| Notice of Allowance Data Verification Completed | 30 Aug, 2025 | US12514906 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Aug, 2025 | US9907834 |
| Information Disclosure Statement considered | 15 Aug, 2025 | US12514906 |
| Terminal Disclaimer Filed | 13 Aug, 2025 | US12514906 |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED | 13 Aug, 2025 | US12514906 |
| Interview Summary - Examiner Initiated - Telephonic | 31 Jul, 2025 | US12514906 |
| Date Forwarded to Examiner | 28 Jul, 2025 | US12514906 |
| Response to Election / Restriction Filed | 24 Jul, 2025 | US12514906 |
| Request for Extension of Time - Granted | 24 Jul, 2025 | US12514906 |
| Information Disclosure Statement (IDS) Filed | 24 Jul, 2025 | US12514906 |
| Electronic Information Disclosure Statement | 24 Jul, 2025 | US12514906 |
| Mail Patent eCofC Notification | 01 Jul, 2025 | US12233106 |
| Patent eCofC Notification | 01 Jul, 2025 | US12233106 |
Biomarin's Drug Patent Litigations
Biomarin's drugs have been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 24, 2025, against patent number US12233106. The petitioner Ascendis Pharma A/S et al., challenged the validity of this patent, with BioMarin Pharmaceutical Inc. as the respondent. Click below to track the latest information on how companies are challenging Biomarin's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US12233106 | November, 2025 | Pending | BioMarin Pharmaceutical Inc. | Ascendis Pharma A/S et al. |
Biomarin Drug Patents' Oppositions Filed in EPO
Biomarin 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 |
|---|---|---|---|
| | |||
| 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's Family Patents
Biomarin 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.
Biomarin Drug List
Given below is the complete list of Biomarin's drugs and the patents protecting them.
1. Kuvan
Kuvan is protected by 22 patents, out of which 18 have expired. 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
(7 years from now)
| Active |
| US9216178 | Dry blend formulation of tetrahydrobiopterin |
01 Nov, 2032
(6 years from now)
| Active |
| US7566462
(Pediatric)
| Stable tablet formulation |
16 May, 2026
(a month from now)
| Active |
| US8003126
(Pediatric)
| Stable tablet formulation |
16 May, 2026
(a month from now)
| Active |
| US7566462 | Stable tablet formulation |
16 Nov, 2025
(3 months ago)
| Expired |
| US8003126 | Stable tablet formulation |
16 Nov, 2025
(3 months ago)
| Expired |
| US7566714
(Pediatric)
| Methods and compositions for the treatment of metabolic disorders |
17 May, 2025
(9 months ago)
| Expired |
| US7612073
(Pediatric)
| Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
17 May, 2025
(9 months ago)
| Expired |
| US7727987
(Pediatric)
| Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
17 May, 2025
(9 months ago)
| Expired |
| US7947681
(Pediatric)
| Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
17 May, 2025
(9 months ago)
| Expired |
| US8067416
(Pediatric)
| Methods and compositions for the treatment of metabolic disorders |
17 May, 2025
(9 months ago)
| Expired |
| US8318745
(Pediatric)
| Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
17 May, 2025
(9 months ago)
| Expired |
| US9433624
(Pediatric)
| Methods and compositions for the treatment of metabolic disorders |
17 May, 2025
(9 months ago)
| Expired |
| USRE43797
(Pediatric)
| Methods of administering tetrahydrobiopterin |
17 May, 2025
(9 months ago)
| Expired |
| US7566714 | Methods and compositions for the treatment of metabolic disorders |
17 Nov, 2024
(1 year, 3 months ago)
| Expired |
| US7612073 | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
17 Nov, 2024
(1 year, 3 months ago)
| Expired |
| US7727987 | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
17 Nov, 2024
(1 year, 3 months ago)
| Expired |
| US7947681 | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
17 Nov, 2024
(1 year, 3 months ago)
| Expired |
| US8067416 | Methods and compositions for the treatment of metabolic disorders |
17 Nov, 2024
(1 year, 3 months ago)
| Expired |
| US8318745 | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
17 Nov, 2024
(1 year, 3 months ago)
| Expired |
| US9433624 | Methods and compositions for the treatment of metabolic disorders |
17 Nov, 2024
(1 year, 3 months ago)
| Expired |
| USRE43797 | Methods of administering tetrahydrobiopterin |
17 Nov, 2024
(1 year, 3 months ago)
| Expired |
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 8 patents, out of which none have expired yet. Check out its patent list below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| US12233106 | C-type natriuretic peptide variants to treat skeletal dysplasia in children |
11 Jul, 2042
(16 years from now)
| Active |
| US10646550 | Use of C-type natriuretic peptide variants to treat skeletal dysplasia |
01 Aug, 2036
(10 years from now)
| Active |
| US11590204 | Use of C-type natriuretic peptide variants to treat skeletal dysplasia |
01 Aug, 2036
(10 years from now)
| Active |
| US11911446 | Use of C-type natriuretic peptide variants to treat skeletal dysplasia |
01 Aug, 2036
(10 years from now)
| Active |
| US12514906 | Use Of C-Type Natriuretic Peptide Variants To Treat Skeletal Dysplasia |
01 Aug, 2036
(10 years from now)
| Active |
| US9907834 | Use of C-type natriuretic peptide variants to treat skeletal dysplasia |
01 Aug, 2036
(10 years from now)
| Active |
| US8198242 | Variants of C-type natriuretic peptide |
11 Jun, 2030
(4 years from now)
| Active |
| USRE48267 | Variants of C-type natriuretic peptide |
20 May, 2030
(4 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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