DrugPatentWatch Database Preview
PROCYSBI Drug Profile
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When 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 eight patents protecting this drug.
This drug has thirty-five patent family members in twenty-five countries.
The generic ingredient in PROCYSBI is cysteamine bitartrate. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.
Summary for PROCYSBI
| International Patents: | 35 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 15 |
| Patent Applications: | 85 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | PROCYSBI at DailyMed |
Generic Entry Opportunity 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.
Pharmacology for PROCYSBI
| Drug Class | Cystine Depleting Agent |
| Mechanism of Action | Cystine Disulfide Reduction |
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 | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Horizon Pharma Usa | PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389-002 | Apr 30, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Horizon Pharma Usa | PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389-002 | Apr 30, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Horizon Pharma Usa | PROCYSBI | cysteamine bitartrate | CAPSULE, DELAYED RELEASE;ORAL | 203389-001 | Apr 30, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Non-Orange Book US Patents for PROCYSBI
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,129,433 | Enterically coated cysteamine, cystamine and derivatives thereof | ➤ Sign Up |
| 9,814,689 | Enterically coated cysteamine, cystamine and derivatives thereof | ➤ Sign Up |
| 9,750,708 | Enterically coated cysteamine, cystamine and derivatives thereof | ➤ Sign Up |
| 9,511,039 | Enterically coated cysteamine, cystamine and derivatives thereof | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for PROCYSBI
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Singapore | 11201510126Q | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2007089670 | ➤ Sign Up |
| European Patent Office | 2535044 | ➤ Sign Up |
| Eurasian Patent Organization | 201600089 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for PROCYSBI
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2014 00013 | Denmark | ➤ Sign Up | PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906 |
| /2014 | Austria | ➤ Sign Up | PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910 |
| 0649 | Netherlands | ➤ Sign Up | PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910 |
| 2014000023 | Germany | ➤ Sign Up | PRODUCT NAME: CYSTEAMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/861 20130906 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
