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Cysteamine bitartrateis the generic ingredient in two branded drugs marketed by Horizon Pharma Usa and Mylan, and is included in three NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.
Cysteamine bitartrate has fifty patent family members in thirty-two countries.
There are six drug master file entries for cysteamine bitartrate. One supplier is listed for this compound.
Summary for cysteamine bitartrate
Recent Clinical Trials for cysteamine bitartrate
Identify potential brand extensions & 505(b)(2) entrants
|Children's Hospital Medical Center, Cincinnati||Phase 1|
|Raptor Pharmaceuticals Inc.||Phase 2|
|Raptor Pharmaceuticals Inc.||Phase 2/Phase 3|
Pharmacology for cysteamine bitartrate
|Drug Class||Cystine Depleting Agent |
|Mechanism of Action||Cystine Disulfide Reduction |
|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||203389-001||Apr 30, 2013||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|Horizon Pharma Usa||PROCYSBI||cysteamine bitartrate||GRANULE;ORAL||213491-002||Feb 14, 2020||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||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|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1919458||SPC/GB14/019||United Kingdom||Start Trial||PRODUCT NAME: CYSTEAMINE; REGISTERED: UK EU/1/13/861 20130910|
|1919458||300649||Netherlands||Start Trial||PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910|
|1919458||2014C/018||Belgium||Start Trial||PRODUCT NAME: CYSTEAMINE; AUTHORISATION NUMBER AND DATE: EU/1/13/861 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|
|>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.