DrugPatentWatch Database Preview
PROCYSBI Drug Profile
» See Plans and Pricing
When do Procysbi patents expire, and when can generic versions of Procysbi launch?
Procysbi is a drug marketed by Horizon Pharma Usa and is included in two NDAs. There are sixteen patents protecting this drug.
This drug has fifty-four 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.
US ANDA Litigation and Generic Entry Outlook for Procysbi
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 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: | 54 |
| US Patents: | 16 |
| Applicants: | 1 |
| NDAs: | 2 |
| Bulk Api Vendors: | 19 |
| Patent Applications: | 112 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROCYSBI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PROCYSBI |
| DailyMed Link: | PROCYSBI at DailyMed |
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.
Paragraph IV (Patent) Challenges for PROCYSBI
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PROCYSBI | CAPSULE, DELAYED RELEASE;ORAL | cysteamine bitartrate | 203389 | 2020-05-11 |
US Patents and Regulatory Information for PROCYSBI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Horizon Pharma Usa | PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491-001 | Feb 14, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Horizon Pharma Usa | PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389-002 | Apr 30, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Horizon Pharma Usa | PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491-001 | Feb 14, 2020 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Horizon Pharma Usa | PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491-002 | Feb 14, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Horizon Pharma Usa | PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491-001 | Feb 14, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Horizon Pharma Usa | PROCYSBI | cysteamine bitartrate | GRANULE, DELAYED RELEASE;ORAL | 213491-002 | Feb 14, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2388310 | Start Trial |
| Portugal | 1919458 | Start Trial |
| Israel | 193044 | Start Trial |
| Eurasian Patent Organization | 200801752 | Start Trial |
| Brazil | PI0707277 | Start Trial |
| Japan | 6468661 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PROCYSBI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1919458 | 19/2014 | Austria | Start Trial | PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910 |
| 1919458 | CR 2014 00013 | Denmark | Start Trial | PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906 |
| 1919458 | 122014000023 | Germany | Start Trial | PRODUCT NAME: CYSTEAMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/861 20130906 |
| 1919458 | 300649 | Netherlands | Start Trial | PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910 |
| 1919458 | C 2014 012 | Romania | Start Trial | PRODUCT NAME: CISTEAMINABITARTRAT; NATIONAL AUTHORISATION NUMBER: EU/1/13/861; DATE OF NATIONAL AUTHORISATION: 20130906; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/861; DATE OF FIRST AUTHORISATION IN EEA: 20130906 |
| 1919458 | C01919458/01 | Switzerland | Start Trial | PRODUCT NAME: MERCAPTAMIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67129 16.08.2019 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
