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 | 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 Pharm's Drug Patents
Given below is the list of recent legal activities going on the following drug patents of Biomarin Pharm.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
|
Maintenance Fee Reminder Mailed
Critical
| 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 |
|---|---|---|---|
 | |||
| 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.
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 8 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
(7 years from now)
| Active |
| US7566462
(Pediatric)
| Stable tablet formulation |
16 May, 2026
(1 year, 4 days from now)
| Active |
| US8003126
(Pediatric)
| Stable tablet formulation |
16 May, 2026
(1 year, 4 days from now)
| Active |
| US7566462 | Stable tablet formulation |
16 Nov, 2025
(6 months from now)
| Active |
| US8003126 | Stable tablet formulation |
16 Nov, 2025
(6 months from now)
| Active |
| US7566714
(Pediatric)
| Methods and compositions for the treatment of metabolic disorders |
17 May, 2025
(5 days from now)
| Active |
| US7612073
(Pediatric)
| Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
17 May, 2025
(5 days from now)
| Active |
| US7727987
(Pediatric)
| Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
17 May, 2025
(5 days from now)
| Active |
| US7947681
(Pediatric)
| Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
17 May, 2025
(5 days from now)
| Active |
| US8067416
(Pediatric)
| Methods and compositions for the treatment of metabolic disorders |
17 May, 2025
(5 days from now)
| Active |
| US8318745
(Pediatric)
| Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
17 May, 2025
(5 days from now)
| Active |
| US9433624
(Pediatric)
| Methods and compositions for the treatment of metabolic disorders |
17 May, 2025
(5 days from now)
| Active |
| USRE43797
(Pediatric)
| Methods of administering tetrahydrobiopterin |
17 May, 2025
(5 days from now)
| Active |
| US7566714 | Methods and compositions for the treatment of metabolic disorders |
17 Nov, 2024
(5 months ago)
| Expired |
| US7612073 | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
17 Nov, 2024
(5 months ago)
| Expired |
| US7727987 | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
17 Nov, 2024
(5 months ago)
| Expired |
| US7947681 | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
17 Nov, 2024
(5 months ago)
| Expired |
| US8067416 | Methods and compositions for the treatment of metabolic disorders |
17 Nov, 2024
(5 months ago)
| Expired |
| US8318745 | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
17 Nov, 2024
(5 months ago)
| Expired |
| US9433624 | Methods and compositions for the treatment of metabolic disorders |
17 Nov, 2024
(5 months ago)
| Expired |
| USRE43797 | Methods of administering tetrahydrobiopterin |
17 Nov, 2024
(5 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 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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