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 Horizon Pharma Usa and is included in two NDAs. There are twelve patents protecting this drug and two Paragraph IV challenges.
This drug has fifty-eight patent family members in thirty-three countries.
The generic ingredient in PROCYSBI is cysteamine bitartrate. There are six drug master file entries for this compound. One supplier is 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
Summary for PROCYSBI
International Patents: | 58 |
US Patents: | 12 |
Applicants: | 2 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 8 |
Clinical Trials: | 1 |
Patent Applications: | 31 |
Formulation / Manufacturing: | see details |
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 Generic Entry Opportunity Date for PROCYSBI
Generic Entry Dates for PROCYSBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE, DELAYED RELEASE;ORAL |
Generic Entry Dates for PROCYSBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GRANULE, DELAYED RELEASE;ORAL |
*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 |
---|---|
Raptor Pharmaceuticals Inc. | Phase 3 |
Horizon Pharma USA, Inc. | Phase 3 |
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 five FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of PROCYSBI is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
Methods for storing cysteamine formulations and related methods of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
Methods for storing Cysteamine formulations and related methods of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
Enterically coated cystamine, cysteamine and derivatives thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Delayed release cysteamine bead formulation, and methods of making and using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Delayed release cysteamine bead formulation, and methods of making and using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
FDA Regulatory Exclusivity protecting PROCYSBI
TO EXPAND THE INDICATION TO PEDIATRIC PATIENTS 2-6 YEARS OF AGE WITH NEPHROPATHIC CYSTINOSIS
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF NEPHROPATHIC CYSTINOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE TO LESS THAN 2 YEARS OF AGE
Exclusivity Expiration: See Plans and Pricing
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing
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: See Plans and Pricing
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: See Plans and Pricing
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
Estimated Expiration: See Plans and Pricing
Australia
Patent: 14281702
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2015031417
Estimated Expiration: See Plans and Pricing
Canada
Patent: 14770
Estimated Expiration: See Plans and Pricing
Patent: 38644
Estimated Expiration: See Plans and Pricing
Chile
Patent: 15003662
Estimated Expiration: See Plans and Pricing
China
Patent: 5492000
Estimated Expiration: See Plans and Pricing
Patent: 0664780
Estimated Expiration: See Plans and Pricing
Cuba
Patent: 150178
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 1255
Estimated Expiration: See Plans and Pricing
Patent: 1690036
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 10491
Estimated Expiration: See Plans and Pricing
Patent: 39574
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 18066
Estimated Expiration: See Plans and Pricing
Israel
Patent: 4823
Estimated Expiration: See Plans and Pricing
Japan
Patent: 68661
Estimated Expiration: See Plans and Pricing
Patent: 16523250
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 15017366
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 4517
Estimated Expiration: See Plans and Pricing
Nicaragua
Patent: 1500177
Estimated Expiration: See Plans and Pricing
Philippines
Patent: 015502783
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 201510126Q
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1508783
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 2281747
Estimated Expiration: See Plans and Pricing
Patent: 160045053
Estimated Expiration: See Plans and Pricing
Patent: 210094140
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 49100
Estimated Expiration: See Plans and Pricing
Patent: 1534357
Estimated Expiration: See Plans and Pricing
Tunisia
Patent: 15000549
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 7833
Estimated Expiration: See Plans and Pricing
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 |
---|---|---|---|
Cuba | 20150178 | FORMULACIÓN EN PERLAS DE CISTEAMINA DE LIBERACIÓN RETARDADA | See Plans and Pricing |
Mexico | 2015017366 | FORMULACION DE PERLAS DE CISTEAMINA DE LIBERACION RETARDADA. (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION.) | See Plans and Pricing |
Eurasian Patent Organization | 200801752 | ПОКРЫТЫЕ ЭНТЕРОСОЛЮБИЛЬНОЙ ОБОЛОЧКОЙ ЦИСТЕАМИН И ЦИСТАМИН И ИХ ПРОИЗВОДНЫЕ | See Plans and Pricing |
Nicaragua | 201500177 | FORMULACIÓN EN PERLAS DE CISTEAMINA DE LIBERACIÓN RETARDADA | See Plans and Pricing |
Lithuania | 2535044 | See Plans and Pricing | |
Spain | 2774755 | See Plans and Pricing | |
Slovenia | 1919458 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PROCYSBI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1919458 | 194 50001-2014 | Slovakia | See Plans and Pricing | PRODUCT NAME: MERKAPTAMIN; FIRST REGISTRATION: EU/1/13/861, 20130906 |
1919458 | 300649 | Netherlands | See Plans and Pricing | PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910 |
1919458 | CR 2014 00013 | Denmark | See Plans and Pricing | PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906 |
1919458 | SPC/GB14/019 | United Kingdom | See Plans and Pricing | PRODUCT NAME: CYSTEAMINE; REGISTERED: UK EU/1/13/861 20130910 |
1919458 | C01919458/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: MERCAPTAMIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67129 16.08.2019 |
1919458 | 19/2014 | Austria | See Plans and Pricing | PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910 |
1919458 | C300649 | Netherlands | See Plans and Pricing | PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130906 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |