PROCYSBI Drug Patent Profile

When do Procysbi patents expire, and when can generic versions of Procysbi launch?

Procysbi is a drug marketed by Horizon and is included in two NDAs. There are twelve patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-nine patent family members in thirty-three countries.

The generic ingredient in PROCYSBI is cysteamine bitartrate. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Procysbi

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 17, 2034. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for PROCYSBI

International Patents:	59
US Patents:	12
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	1
Patent Applications:	37
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PROCYSBI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROCYSBI
What excipients (inactive ingredients) are in PROCYSBI?	PROCYSBI excipients list
DailyMed Link:	PROCYSBI at DailyMed

See drug prices for PROCYSBI

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

NDA:

203389

Dosage:

CAPSULE, DELAYED RELEASE;ORAL

NDA:

213491

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 PROCYSBI

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

Sponsor	Phase
Raptor Pharmaceuticals Inc.	Phase 3
Horizon Pharma USA, Inc.	Phase 3

See all PROCYSBI clinical trials

Pharmacology for PROCYSBI

Drug Class	Cystine Depleting Agent
Mechanism of Action	Cystine Disulfide Reduction

Paragraph IV (Patent) Challenges for PROCYSBI

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 PROCYSBI

PROCYSBI is protected by twelve US patents and six FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PROCYSBI

FDA Regulatory Exclusivity protecting PROCYSBI

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	GRANULE, DELAYED RELEASE;ORAL	213491-001	Feb 14, 2020		RX	Yes	No					Y
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389-002	Apr 30, 2013		RX	Yes	Yes
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-001	Feb 14, 2020		RX	Yes	No
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-002	Feb 14, 2020		RX	Yes	Yes					Y
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-001	Feb 14, 2020		RX	Yes	No
Horizon	PROCYSBI	cysteamine bitartrate	GRANULE, DELAYED RELEASE;ORAL	213491-001	Feb 14, 2020		RX	Yes	No

International Patents for PROCYSBI

When does loss-of-exclusivity occur for PROCYSBI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Cuba

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Nicaragua

Philippines

Singapore

South Africa

South Korea

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PROCYSBI around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	2535044
China	110664780	延迟释放型半胱胺珠粒调配物，以及其制备及使用方法 (Delayed release cysteamine bead formulation, and method of manufacture and use thereof)
Mexico	2015017366	FORMULACION DE PERLAS DE CISTEAMINA DE LIBERACION RETARDADA. (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION.)
Japan	2016523250	遅延放出システアミンビーズ処方、ならびにその作製方法および使用方法
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)
Lithuania	2535044

Supplementary Protection Certificates for PROCYSBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1919458	300649	Netherlands		PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
1919458	194 50001-2014	Slovakia		PRODUCT NAME: MERKAPTAMIN; FIRST REGISTRATION: EU/1/13/861, 20130906
1919458	C 2014 012	Romania		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		PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906
1919458	C01919458/01	Switzerland		PRODUCT NAME: MERCAPTAMIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67129 16.08.2019
1919458	C300649	Netherlands		PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130906