Procysbi is a drug owned by Horizon Therapeutics Usa Inc. It is protected by 25 US drug patents filed from 2013 to 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 16, 2037. Details of Procysbi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US9925156 | Enterically coated cysteamine, cystamine and derivatives thereof |
Jan, 2027
(2 years from now) | Active |
| US9925157 | Enterically coated cysteamine, cystamine and derivatives thereof |
Jan, 2027
(2 years from now) | Active |
| US9925158 | Enterically coated cysteamine, cystamine and derivatives thereof |
Jan, 2027
(2 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9925158 | Enterically coated cysteamine, cystamine and derivatives thereof |
Jan, 2027
(2 years from now) | Active |
| US9198882 | Enterically coated cysteamine, cystamine and derivatives thereof |
Jan, 2027
(2 years from now) | Active |
| US9925157 | Enterically coated cysteamine, cystamine and derivatives thereof |
Jan, 2027
(2 years from now) | Active |
| US8129433 | Enterically coated cysteamine, cystamine and derivatives thereof |
Jan, 2027
(2 years from now) | Active |
| US9925156 | Enterically coated cysteamine, cystamine and derivatives thereof |
Jan, 2027
(2 years from now) | Active |
| US9192590 | Enterically coated cysteamine, cystamine and derivatives thereof |
Jan, 2027
(2 years from now) | Active |
|
US9192590 (Pediatric) | Enterically coated cysteamine, cystamine and derivatives thereof |
Jul, 2027
(2 years from now) | Active |
|
US9198882 (Pediatric) | Enterically coated cysteamine, cystamine and derivatives thereof |
Jul, 2027
(2 years from now) | Active |
|
US9925156 (Pediatric) | Enterically coated cysteamine, cystamine and derivatives thereof |
Jul, 2027
(2 years from now) | Active |
|
US9925158 (Pediatric) | Enterically coated cysteamine, cystamine and derivatives thereof |
Jul, 2027
(2 years from now) | Active |
|
US9925157 (Pediatric) | Enterically coated cysteamine, cystamine and derivatives thereof |
Jul, 2027
(2 years from now) | Active |
| US8026284 | Enterically coated cystamine, cysteamine and derivatives thereof |
Sep, 2027
(3 years from now) | Active |
|
US8026284 (Pediatric) | Enterically coated cystamine, cysteamine and derivatives thereof |
Mar, 2028
(3 years from now) | Active |
| US9173851 | Delayed release cysteamine bead formulation, and methods of making and using same |
Jun, 2034
(9 years from now) | Active |
| US9233077 | Delayed release cysteamine bead formulation, and methods of making and using same |
Jun, 2034
(9 years from now) | Active |
|
US9173851 (Pediatric) | Delayed release cysteamine bead formulation, and methods of making and using same |
Dec, 2034
(10 years from now) | Active |
|
US9233077 (Pediatric) | Delayed release cysteamine bead formulation, and methods of making and using same |
Dec, 2034
(10 years from now) | Active |
| US10548859 | Methods for storing Cysteamine formulations and related methods of treatment |
Aug, 2036
(12 years from now) | Active |
| US10905662 | Methods for storing cysteamine formulations and related methods of treatment |
Aug, 2036
(12 years from now) | Active |
| US10328037 | Methods for storing cysteamine formulations and related methods of treatment |
Aug, 2036
(12 years from now) | Active |
| US10143665 | Methods for storing cysteamine formulations and related methods of treatment |
Aug, 2036
(12 years from now) | Active |
|
US10905662 (Pediatric) | Methods for storing cysteamine formulations and related methods of treatment |
Feb, 2037
(12 years from now) | Active |
|
US10328037 (Pediatric) | Methods for storing cysteamine formulations and related methods of treatment |
Feb, 2037
(12 years from now) | Active |
|
US10143665 (Pediatric) | Methods for storing cysteamine formulations and related methods of treatment |
Feb, 2037
(12 years from now) | Active |
|
US10548859 (Pediatric) | Methods for storing Cysteamine formulations and related methods of treatment |
Feb, 2037
(12 years from now) | Active |
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 Procysbi's patents.
Latest Legal Activities on Procysbi's Patents
Given below is the list of recent legal activities going on the following patents of Procysbi.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Aug, 2023 | US10548859 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Jul, 2023 | US9233077 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Jun, 2023 | US9198882 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 May, 2023 | US9192590 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 May, 2023 | US9173851 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Mar, 2023 | US8026284 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Dec, 2022 | US10328037 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 06 Jun, 2022 | US10143665 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Sep, 2021 | US9925156 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Sep, 2021 | US9925157 |
FDA has granted several exclusivities to Procysbi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Procysbi, 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 Procysbi.
Exclusivity Information
Procysbi holds 8 exclusivities out of which 6 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Procysbi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Apr 30, 2016 |
| New Patient Population(NPP) | Aug 14, 2018 |
| Orphan Drug Exclusivity(ODE-45) | Apr 30, 2020 |
| M(M-216) | Dec 22, 2020 |
| Orphan Drug Exclusivity(ODE) | Aug 14, 2022 |
| Orphan Drug Exclusivity(ODE-97) | Aug 14, 2022 |
| Orphan Drug Exclusivity(ODE-162) | Dec 22, 2024 |
| Pediatric Exclusivity(PED) | Jun 22, 2025 |
Several oppositions have been filed on Procysbi'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 Procysbi's generic, the next section provides detailed information on ongoing and past EP oppositions related to Procysbi patents.
Procysbi's oppositions filed in EPO
Procysbi has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 18, 2020, by Alfred E. Tiefenbacher (Gmbh & Co. Kg). This opposition was filed on patent number EP12169866A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP12169866A | Sep, 2020 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Procysbi 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 Procysbi's family patents as well as insights into ongoing legal events on those patents.
Procysbi's family patents
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Generic Launch
Generic Release Date:
Procysbi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 16, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Procysbi Generics:
There are no approved generic versions for Procysbi as of now.
How can I launch a generic of Procysbi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Procysbi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Procysbi'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 Procysbi -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg and 75 mg | 11 May, 2020 | 1 | 16 Aug, 2036 | ||
| 75 mg/Packet and 300 mg/Packet | 16 Dec, 2021 | 1 | 16 Aug, 2036 |
About Procysbi
Procysbi is a drug owned by Horizon Therapeutics Usa Inc. It is used for treating nephropathic cystinosis. Procysbi uses Cysteamine Bitartrate as an active ingredient. Procysbi was launched by Horizon in 2013.
Market Authorisation Date:
Procysbi was approved by FDA for market use on 30 April, 2013.
Active Ingredient:
Procysbi uses Cysteamine Bitartrate as the active ingredient. Check out other Drugs and Companies using Cysteamine Bitartrate ingredient
Treatment:
Procysbi is used for treating nephropathic cystinosis.
Dosage:
Procysbi is available in the following dosage forms - granule, delayed release form for oral use, capsule, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 75MG BASE | CAPSULE, DELAYED RELEASE | Prescription | ORAL |
| EQ 75MG BASE/PACKET | GRANULE, DELAYED RELEASE | Prescription | ORAL |
| EQ 25MG BASE | CAPSULE, DELAYED RELEASE | Prescription | ORAL |
| EQ 300MG BASE/PACKET | GRANULE, DELAYED RELEASE | Prescription | ORAL |