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

International Patents:	62
US Patents:	12
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	15
Patent Applications:	279
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CYSTEAMINE BITARTRATE
What excipients (inactive ingredients) are in CYSTEAMINE BITARTRATE?	CYSTEAMINE BITARTRATE excipients list
DailyMed Link:	CYSTEAMINE BITARTRATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CYSTEAMINE BITARTRATE

Generic Entry Dates for CYSTEAMINE BITARTRATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CAPSULE, DELAYED RELEASE;ORAL
Generic Entry Dates for CYSTEAMINE BITARTRATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

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

See all CYSTEAMINE BITARTRATE clinical trials

Pharmacology for CYSTEAMINE BITARTRATE

Drug Class	Cystine Depleting Agent
Mechanism of Action	Cystine Disulfide Reduction

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

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Glossary

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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			Y	⤷ Sign Up
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-002	Feb 14, 2020		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
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-002	Feb 14, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Mylan	CYSTAGON	cysteamine bitartrate	CAPSULE;ORAL	020392-001	Aug 15, 1994		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				⤷ 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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2014204881		⤷ Sign Up
New Zealand	714517	Delayed release cysteamine bead formulation	⤷ Sign Up
Portugal	2535044		⤷ Sign Up
Israel	302141	פורמולצית bead של ציסטאמין בעל שחרור מושהה, שיטות להכנתה ולשימוש בה (Delayed release cysteamine bead formulation, and methods of making and using same)	⤷ Sign Up
Nicaragua	201500177	FORMULACIÓN EN PERLAS DE CISTEAMINA DE LIBERACIÓN RETARDADA	⤷ Sign Up
Brazil	112015031417	forma de dosagem farmacêutica, composição farmacêutica, métodos para tratamento de um paciente com necessidade de cisteamina e para preparo de uma forma de dosagem	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CYSTEAMINE BITARTRATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1919458	19/2014	Austria	⤷ Sign Up	PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
1919458	SPC/GB14/019	United Kingdom	⤷ Sign Up	PRODUCT NAME: CYSTEAMINE; REGISTERED: UK EU/1/13/861 20130910
1919458	122014000023	Germany	⤷ Sign Up	PRODUCT NAME: CYSTEAMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/861 20130906
1919458	CR 2014 00013	Denmark	⤷ Sign Up	PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906
1919458	C01919458/01	Switzerland	⤷ Sign Up	PRODUCT NAME: MERCAPTAMIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67129 16.08.2019
1919458	194 50001-2014	Slovakia	⤷ Sign Up	PRODUCT NAME: MERKAPTAMIN; FIRST REGISTRATION: EU/1/13/861, 20130906
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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