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PROCYSBI Drug Profile
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See Plans and PricingWhen do Procysbi patents expire, and what generic alternatives are available?
Procysbi is a drug marketed by Horizon Pharma Usa and is included in one NDA. There are ten patents protecting this drug.
This drug has forty-four patent family members in thirty 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.
US ANDA Litigation and Generic Entry Outlook for Procysbi
Indicators of Generic Entry
Summary for PROCYSBI
| International Patents: | 44 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 18 |
| Patent Applications: | 107 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | PROCYSBI at DailyMed |
Pharmacology for PROCYSBI
| Drug Class | Cystine Depleting Agent |
| Mechanism of Action | Cystine Disulfide Reduction |
Synonyms for PROCYSBI
| (+/-)-Tartaric Acid |
| 2-aminoethanethiol 2,3-dihydroxysuccinate |
| 27761-19-9 |
| AKOS024332936 |
| AKOS032954217 |
| BC245627 |
| beta-Mercaptoethylamine bitartrate |
| beta-Mercaptoethylamine hydrogen tartrate |
| CHEBI:50386 |
| CHEMBL2062263 |
| CTK4G0224 |
| CYSTEAMINE BITARTRATE |
| Cysteamine bitartrate (JAN) |
| D10468 |
| EINECS 248-641-7 |
| Ethanethiol, 2-amino-, tartrate (1:1) (salt) |
| FT-0696891 |
| MCULE-1129308393 |
| Mercaptamine bitartrate |
| Procysbi (TN) |
| QO84GZ3TST |
| RP103 |
| SCHEMBL49513 |
| UNII-QO84GZ3TST |
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 | CAPSULE, DELAYED RELEASE;ORAL | 203389-002 | Apr 30, 2013 | RX | Yes | Yes | Start Trial | Start Trial | 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 | CAPSULE, DELAYED RELEASE;ORAL | 203389-002 | Apr 30, 2013 | RX | Yes | Yes | Start Trial | Start Trial | 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 | CAPSULE, DELAYED RELEASE;ORAL | 203389-001 | Apr 30, 2013 | RX | Yes | No | Start Trial | Start Trial | Y | 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 | Y | 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 | Y | 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 |
|---|---|---|
| Australia | 2014281702 | Start Trial |
| Cuba | 20150178 | Start Trial |
| Brazil | PI0707277 | Start Trial |
| Tunisia | 2015000549 | Start Trial |
| Canada | 2914770 | Start Trial |
| Poland | 1919458 | Start Trial |
| Australia | 2007210005 | 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 | C300649 | Netherlands | Start Trial | PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130906 |
| 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 | 122014000023 | Germany | Start Trial | PRODUCT NAME: CYSTEAMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/861 20130906 |
| 1919458 | 2014C/018 | Belgium | Start Trial | PRODUCT NAME: CYSTEAMINE; AUTHORISATION NUMBER AND DATE: EU/1/13/861 20130910 |
| 1919458 | CR 2014 00013 | Denmark | Start Trial | PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
