PROCYSBI Drug Patent Profile
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When do Procysbi patents expire, and when can generic versions of Procysbi launch?
Procysbi is a drug marketed by Horizon and is included in two NDAs. There are twelve patents protecting this drug and two Paragraph IV challenges.
This drug has sixty-two patent family members in thirty-four countries.
The generic ingredient in PROCYSBI is cysteamine bitartrate. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.
DrugPatentWatch® Generic Entry Outlook for Procysbi
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 17, 2034. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Summary for PROCYSBI
| International Patents: | 62 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 13 |
| Clinical Trials: | 1 |
| Patent Applications: | 15 |
| Drug Prices: | Drug price information for PROCYSBI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PROCYSBI |
| What excipients (inactive ingredients) are in PROCYSBI? | PROCYSBI excipients list |
| DailyMed Link: | PROCYSBI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PROCYSBI
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for PROCYSBI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Horizon Pharma USA, Inc. | Phase 3 |
| Raptor Pharmaceuticals Inc. | Phase 3 |
Pharmacology for PROCYSBI
| Drug Class | Cystine Depleting Agent |
| Mechanism of Action | Cystine Disulfide Reduction |
Paragraph IV (Patent) Challenges for PROCYSBI
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PROCYSBI | Delayed-release Granules | cysteamine bitartrate | 75 mg/Packet and 300 mg/Packet | 213491 | 1 | 2021-12-16 |
| PROCYSBI | Delayed-release Capsules | cysteamine bitartrate | 25 mg and 75 mg | 203389 | 1 | 2020-05-11 |
US Patents and Regulatory Information for PROCYSBI
PROCYSBI is protected by twelve US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of PROCYSBI is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting PROCYSBI
Methods for storing cysteamine formulations and related methods of treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods for storing cysteamine formulations and related methods of treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods for storing Cysteamine formulations and related methods of treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enterically coated cystamine, cysteamine and derivatives thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Delayed release cysteamine bead formulation, and methods of making and using same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Delayed release cysteamine bead formulation, and methods of making and using same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting PROCYSBI
TREATMENT OF NEPHROPATHIC CYSTINOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE TO LESS THAN 2 YEARS OF AGE
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Horizon | PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491-001 | Feb 14, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Horizon | PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491-001 | Feb 14, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Horizon | PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491-002 | Feb 14, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Horizon | PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491-002 | Feb 14, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Horizon | PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491-002 | Feb 14, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Horizon | PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491-002 | Feb 14, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Horizon | PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389-002 | Apr 30, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for PROCYSBI
When does loss-of-exclusivity occur for PROCYSBI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 6628
Patent: FORMULACIÓN EN PERLAS DE CISTEAMINA DE LIBERACIÓN RETARDADA Y MÉTODOS DE PREPARACIÓN Y USO DE ELLA
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 14281702
Patent: Delayed release cysteamine bead formulation
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2015031417
Patent: forma de dosagem farmacêutica, composição farmacêutica, métodos para tratamento de um paciente com necessidade de cisteamina e para preparo de uma forma de dosagem
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 14770
Patent: PREPARATION DE BILLES DE CYSTEAMINE A LIBERATION RETARDEE (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION, AND METHODS OF MAKING AND USING SAME)
Estimated Expiration: ⤷ Sign Up
Patent: 38644
Patent: PREPARATION DE BILLES DE CYSTEAMINE A LIBERATION RETARDEE (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION, AND METHODS OF MAKING AND USING SAME)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 15003662
Patent: Formulación en perlas de cisteamina de liberación retardada.
Estimated Expiration: ⤷ Sign Up
China
Patent: 5492000
Patent: Delayed release cysteamine bead formulation
Estimated Expiration: ⤷ Sign Up
Patent: 0664780
Patent: 延迟释放型半胱胺珠粒调配物，以及其制备及使用方法 (Delayed release cysteamine bead formulation, and method of manufacture and use thereof)
Estimated Expiration: ⤷ Sign Up
Cuba
Patent: 150178
Patent: FORMULACIÓN EN PERLAS DE CISTEAMINA DE LIBERACIÓN RETARDADA
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 1255
Patent: СОСТАВ С ОТСРОЧЕННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЙ ГРАНУЛЫ ЦИСТЕАМИНА, И СПОСОБЫ ЕГО ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION AND METHODS FOR THE PREPARATION AND USE THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 1690036
Patent: СОСТАВ С ОТСРОЧЕННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЙ ГРАНУЛЫ ЦИСТЕАМИНА, И СПОСОБЫ ЕГО ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 10491
Patent: PRÉPARATION DE BILLES DE CYSTÉAMINE À LIBÉRATION RETARDÉE (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 39574
Patent: PRÉPARATION DE BILLES DE CYSTÉAMINE À LIBÉRATION RETARDÉE (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 18066
Patent: 延遲釋放型半胱胺珠粒調配物 (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4823
Patent: פורמולצית bead של ציסטאמין בעל שחרור מושהה, שיטות להכנתה ולשימוש בה (Delayed release cysteamine bead formulation, and methods of making and using same)
Estimated Expiration: ⤷ Sign Up
Patent: 2141
Patent: פורמולצית bead של ציסטאמין בעל שחרור מושהה, שיטות להכנתה ולשימוש בה (Delayed release cysteamine bead formulation, and methods of making and using same)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 68661
Estimated Expiration: ⤷ Sign Up
Patent: 16523250
Patent: 遅延放出システアミンビーズ処方、ならびにその作製方法および使用方法
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 15017366
Patent: FORMULACION DE PERLAS DE CISTEAMINA DE LIBERACION RETARDADA. (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 4517
Patent: Delayed release cysteamine bead formulation
Estimated Expiration: ⤷ Sign Up
Nicaragua
Patent: 1500177
Patent: FORMULACIÓN EN PERLAS DE CISTEAMINA DE LIBERACIÓN RETARDADA
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 015502783
Patent: DELAYED RELEASE CYSTEAMINE BEAD FORMULATION
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201510126Q
Patent: DELAYED RELEASE CYSTEAMINE BEAD FORMULATION
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1508783
Patent: DELAYED RELEASE CYSTEAMINE BEAD FORMULATION
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2281747
Estimated Expiration: ⤷ Sign Up
Patent: 2466253
Estimated Expiration: ⤷ Sign Up
Patent: 160045053
Patent: 서방성 시스테아민 비드 투약 형태 (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION)
Estimated Expiration: ⤷ Sign Up
Patent: 210094140
Patent: 서방성 시스테아민 비드 투약 형태 (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION)
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 49100
Estimated Expiration: ⤷ Sign Up
Patent: 1534357
Patent: Delayed release cysteamine bead formulation, and methods of making and using same
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 15000549
Patent: DELAYED RELEASE CYSTEAMINE BEAD FORMULATION
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 7833
Patent: СКЛАД З ВІДСТРОЧЕНИМ ВИВІЛЬНЕННЯМ, ЩО МІСТИТЬ ГРАНУЛИ ЦИСТЕАМІНУ, І СПОСОБИ ЙОГО ОДЕРЖАННЯ ТА ЗАСТОСУВАННЯ (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION)
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering PROCYSBI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3010491 | PRÉPARATION DE BILLES DE CYSTÉAMINE À LIBÉRATION RETARDÉE (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION) | ⤷ Sign Up |
| Philippines | 12015502783 | DELAYED RELEASE CYSTEAMINE BEAD FORMULATION | ⤷ Sign Up |
| Portugal | 2535044 | ⤷ Sign Up | |
| Israel | 302141 | פורמולצית bead של ציסטאמין בעל שחרור מושהה, שיטות להכנתה ולשימוש בה (Delayed release cysteamine bead formulation, and methods of making and using same) | ⤷ Sign Up |
| China | 110664780 | 延迟释放型半胱胺珠粒调配物，以及其制备及使用方法 (Delayed release cysteamine bead formulation, and method of manufacture and use thereof) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2014204881 | ⤷ Sign Up | |
| Cuba | 20150178 | FORMULACIÓN EN PERLAS DE CISTEAMINA DE LIBERACIÓN RETARDADA | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PROCYSBI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1919458 | 19/2014 | Austria | ⤷ Sign Up | PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910 |
| 1919458 | SPC/GB14/019 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: CYSTEAMINE; REGISTERED: UK EU/1/13/861 20130910 |
| 1919458 | 122014000023 | Germany | ⤷ Sign Up | PRODUCT NAME: CYSTEAMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/861 20130906 |
| 1919458 | CR 2014 00013 | Denmark | ⤷ Sign Up | PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906 |
| 1919458 | C01919458/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: MERCAPTAMIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67129 16.08.2019 |
| 1919458 | 194 50001-2014 | Slovakia | ⤷ Sign Up | PRODUCT NAME: MERKAPTAMIN; FIRST REGISTRATION: EU/1/13/861, 20130906 |
| 1919458 | C300649 | Netherlands | ⤷ Sign Up | PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130906 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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