Kuvan is a drug owned by Biomarin Pharmaceutical Inc. It is protected by 22 US drug patents filed from 2013 to 2022. Out of these, 14 drug patents are active and 8 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 01, 2033. Details of Kuvan's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9216178 (Pediatric) | Dry blend formulation of tetrahydrobiopterin |
May, 2033
(7 years from now) | Active |
| US9216178 | Dry blend formulation of tetrahydrobiopterin |
Nov, 2032
(7 years from now) | Active |
|
US8003126 (Pediatric) | Stable tablet formulation |
May, 2026
(1 year, 6 days from now) | Active |
|
US7566462 (Pediatric) | Stable tablet formulation |
May, 2026
(1 year, 6 days from now) | Active |
| US7566462 | Stable tablet formulation |
Nov, 2025
(6 months from now) | Active |
| US8003126 | Stable tablet formulation |
Nov, 2025
(6 months from now) | Active |
|
US7566714 (Pediatric) | Methods and compositions for the treatment of metabolic disorders |
May, 2025
(7 days from now) | Active |
|
US7947681 (Pediatric) | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
May, 2025
(7 days from now) | Active |
|
US7612073 (Pediatric) | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
May, 2025
(7 days from now) | Active |
|
US7727987 (Pediatric) | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
May, 2025
(7 days from now) | Active |
|
US8067416 (Pediatric) | Methods and compositions for the treatment of metabolic disorders |
May, 2025
(7 days from now) | Active |
|
US8318745 (Pediatric) | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
May, 2025
(7 days from now) | Active |
|
USRE43797 (Pediatric) | Methods of administering tetrahydrobiopterin |
May, 2025
(7 days from now) | Active |
|
US9433624 (Pediatric) | Methods and compositions for the treatment of metabolic disorders |
May, 2025
(7 days from now) | Active |
| US7566714 | Methods and compositions for the treatment of metabolic disorders |
Nov, 2024
(5 months ago) |
Expired
|
| US7947681 | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
Nov, 2024
(5 months ago) |
Expired
|
| US7612073 | Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring |
Nov, 2024
(5 months ago) |
Expired
|
| US8067416 | Methods and compositions for the treatment of metabolic disorders |
Nov, 2024
(5 months ago) |
Expired
|
| US9433624 | Methods and compositions for the treatment of metabolic disorders |
Nov, 2024
(5 months ago) |
Expired
|
| USRE43797 | Methods of administering tetrahydrobiopterin |
Nov, 2024
(5 months ago) |
Expired
|
| US7727987 | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
Nov, 2024
(5 months ago) |
Expired
|
| US8318745 | Crystalline forms of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride |
Nov, 2024
(5 months ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Kuvan's patents.
Latest Legal Activities on Kuvan's Patents
Given below is the list of recent legal activities going on the following patents of Kuvan.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 29 Apr, 2024 | US9433624 (Litigated) |
| 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) |
| 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) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 06 Mar, 2020 | US9433624 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Jun, 2019 | US9216178 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 May, 2019 | US8067416 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Feb, 2019 | US8003126 (Litigated) |
FDA has granted several exclusivities to Kuvan. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kuvan, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Kuvan.
Exclusivity Information
Kuvan holds 4 exclusivities. All of its exclusivities have expired in 2017. Details of Kuvan's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 13, 2012 |
| Orphan Drug Exclusivity(ODE) | Dec 13, 2014 |
| New Patient Population(NPP) | Apr 23, 2017 |
| Pediatric Exclusivity(PED) | Oct 23, 2017 |
Several oppositions have been filed on Kuvan's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Kuvan's generic, the next section provides detailed information on ongoing and past EP oppositions related to Kuvan patents.
Kuvan's Oppositions Filed in EPO
Kuvan has 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 | Coripharma ehf. | Granted and Under Opposition |
| EP18205446A | Nov, 2022 | Dipharma S.A. | Granted and Under Opposition |
| EP18205446A | Oct, 2022 | betapharm Arzneimittel GmbH | Granted and Under Opposition |
| EP16178739A | Oct, 2022 | Dipharma S.A. | Granted and Under Opposition |
| EP18205446A | Oct, 2022 | SANDOZ AG | Granted and Under Opposition |
| EP16178739A | Oct, 2022 | TOBIO NOVELFARMA ILAC SAN. VE TIC. A.S. | Granted and Under Opposition |
| EP16178739A | Oct, 2022 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP18205446A | Oct, 2022 | STADA Arzneimittel AG | 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 |
US patents provide insights into the exclusivity only within the United States, but Kuvan is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Kuvan's family patents as well as insights into ongoing legal events on those patents.
Kuvan's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Kuvan's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 01, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kuvan Generic API suppliers:
Sapropterin Dihydrochloride is the generic name for the brand Kuvan. 3 different companies have already filed for the generic of Kuvan, with Annora Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Kuvan's generic
How can I launch a generic of Kuvan before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Kuvan's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kuvan's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Kuvan -
| 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 |
About Kuvan
Kuvan is a drug owned by Biomarin Pharmaceutical Inc. It is used for reducing blood phenylalanine levels in patients with hyperphenylalaninemia. Kuvan uses Sapropterin Dihydrochloride as an active ingredient. Kuvan was launched by Biomarin Pharm in 2013.
Approval Date:
Kuvan was approved by FDA for market use on 19 December, 2013.
Active Ingredient:
Kuvan uses Sapropterin Dihydrochloride as the active ingredient. Check out other Drugs and Companies using Sapropterin Dihydrochloride ingredient
Treatment:
Kuvan is used for reducing blood phenylalanine levels in patients with hyperphenylalaninemia.
Dosage:
Kuvan is available in the following dosage forms - powder form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG/PACKET | POWDER | Prescription | ORAL |
| 100MG/PACKET | POWDER | Prescription | ORAL |
| 100MG | TABLET | Prescription | ORAL |