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Last Updated: August 11, 2020

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Cysteamine bitartrate - Generic Drug Details

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What are the generic sources for cysteamine bitartrate and what is the scope of freedom to operate?

Cysteamine bitartrate is 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

SponsorPhase
Children's Hospital Medical Center, CincinnatiPhase 1
Raptor Pharmaceuticals Inc.Phase 2
Raptor Pharmaceuticals Inc.Phase 2/Phase 3

See all cysteamine bitartrate clinical trials

Pharmacology for cysteamine bitartrate
Paragraph IV (Patent) Challenges for CYSTEAMINE BITARTRATE
Tradename Dosage Ingredient NDA Submissiondate
PROCYSBI CAPSULE, DELAYED RELEASE;ORAL cysteamine bitartrate 203389 2020-05-11

US Patents and Regulatory Information for cysteamine bitartrate

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

Supplementary Protection Certificates for cysteamine bitartrate

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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Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Dow
Merck
Mallinckrodt
Harvard Business School

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