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Last Updated: November 2, 2024

CYSTEAMINE BITARTRATE - Generic Drug Details


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What are the generic 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 and Mylan, and is included in three NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cysteamine bitartrate has sixty-two patent family members in thirty-four countries.

There are four drug master file entries for cysteamine bitartrate. Two suppliers are listed for this compound.

Summary for CYSTEAMINE BITARTRATE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CYSTEAMINE BITARTRATE
Generic Entry Dates for CYSTEAMINE BITARTRATE*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, DELAYED RELEASE;ORAL
Generic Entry Dates for CYSTEAMINE BITARTRATE*:
Constraining patent/regulatory exclusivity:
Dosage:
GRANULE, DELAYED RELEASE;ORAL

*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.

Recent Clinical Trials for CYSTEAMINE BITARTRATE

Identify potential brand extensions & 505(b)(2) entrants

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

See all CYSTEAMINE BITARTRATE clinical trials

Pharmacology for CYSTEAMINE BITARTRATE
Paragraph IV (Patent) Challenges for CYSTEAMINE BITARTRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PROCYSBI Delayed-release Granules cysteamine bitartrate 75 mg/Packet and 300 mg/Packet 213491 1 2021-12-16
PROCYSBI Delayed-release Capsules cysteamine bitartrate 25 mg and 75 mg 203389 1 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 PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Horizon PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-001 Feb 14, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up 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

International Patents for CYSTEAMINE BITARTRATE

Country Patent Number Title Estimated Expiration
Philippines 12015502783 DELAYED RELEASE CYSTEAMINE BEAD FORMULATION ⤷  Sign Up
Eurasian Patent Organization 023971 ПРИМЕНЕНИЕ КОМПОЗИЦИИ, СОДЕРЖАЩЕЙ ПОКРЫТЫЕ ЭНТЕРОСОЛЮБИЛЬНОЙ ОБОЛОЧКОЙ ЦИСТАМИН ИЛИ ЦИСТЕАМИН, ДЛЯ ЛЕЧЕНИЯ ЦИСТИНОЗА И СПОСОБ ЛЕЧЕНИЯ ЦИСТИНОЗА (USE OF A COMPOSITION COMPRISING ENTERICALLY COATED CYSTAMINE OR CYSTEAMINE FOR TREATING CYSTINOSIS AND METHOD OF TREATING CYSTINOSIS) ⤷  Sign Up
Eurasian Patent Organization 201600089 ПОКРЫТЫЕ ЭНТЕРОСОЛЮБИЛЬНОЙ ОБОЛОЧКОЙ ЦИСТЕАМИН И ЦИСТАМИН И ИХ ПРОИЗВОДНЫЕ ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CYSTEAMINE BITARTRATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1919458 SPC/GB14/019 United Kingdom ⤷  Sign Up PRODUCT NAME: CYSTEAMINE; REGISTERED: UK EU/1/13/861 20130910
1919458 C 2014 012 Romania ⤷  Sign Up 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 CR 2014 00013 Denmark ⤷  Sign Up PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 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.