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Last Updated: June 15, 2021

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CYSTEAMINE BITARTRATE - Generic Drug Details

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What are the generic drug sources for cysteamine bitartrate and what is the scope of patent protection?

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 seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cysteamine bitartrate has fifty-four patent family members in thirty-three countries.

There are six drug master file entries for cysteamine bitartrate. One supplier is listed for this compound.

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   Get Started Free   Get Started Free Y   Get Started Free
Horizon Pharma Usa PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Horizon Pharma Usa PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Horizon Pharma Usa PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
>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   Get Started Free PRODUCT NAME: CYSTEAMINE; REGISTERED: UK EU/1/13/861 20130910
1919458 2014C/018 Belgium   Get Started Free PRODUCT NAME: CYSTEAMINE; AUTHORISATION NUMBER AND DATE: EU/1/13/861 20130910
1919458 C01919458/01 Switzerland   Get Started Free PRODUCT NAME: MERCAPTAMIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67129 16.08.2019
1919458 19/2014 Austria   Get Started Free PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Merck
Dow
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Baxter
McKinsey

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