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PROCYSBI Drug Patent Profile

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Which patents cover Procysbi, and what generic alternatives are available?

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 sixty-two patent family members in thirty-four 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

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Summary for PROCYSBI

International Patents:	62
US Patents:	12
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	1
Patent Applications:	15
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

Drug patent expirations by year for PROCYSBI

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

Generic Entry Dates for PROCYSBI^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 203389 Dosage: CAPSULE, DELAYED RELEASE;ORAL
Generic Entry Dates for PROCYSBI^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PROCYSBI is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Methods for storing cysteamine formulations and related methods of treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Methods for storing Cysteamine formulations and related methods of treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Enterically coated cystamine, cysteamine and derivatives thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Delayed release cysteamine bead formulation, and methods of making and using same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Delayed release cysteamine bead formulation, and methods of making and using same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting PROCYSBI

TREATMENT OF NEPHROPATHIC CYSTINOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE TO LESS THAN 2 YEARS OF AGE
Exclusivity Expiration: ⤷ Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷ Sign Up

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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	GRANULE, DELAYED RELEASE;ORAL	213491-001	Feb 14, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ 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
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	213491-002	Feb 14, 2020		RX	Yes	Yes	⤷ 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				⤷ 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 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

Patent: 6628
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 14281702
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2015031417
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 14770
Estimated Expiration: ⤷ Sign Up

Patent: 38644
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 15003662
Estimated Expiration: ⤷ Sign Up

China

Patent: 5492000
Estimated Expiration: ⤷ Sign Up

Patent: 0664780
Estimated Expiration: ⤷ Sign Up

Cuba

Patent: 150178
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 1255
Estimated Expiration: ⤷ Sign Up

Patent: 1690036
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 10491
Estimated Expiration: ⤷ Sign Up

Patent: 39574
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 18066
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 4823
Estimated Expiration: ⤷ Sign Up

Patent: 2141
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 68661
Estimated Expiration: ⤷ Sign Up

Patent: 16523250
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 15017366
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 4517
Estimated Expiration: ⤷ Sign Up

Nicaragua

Patent: 1500177
Estimated Expiration: ⤷ Sign Up

Philippines

Patent: 015502783
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 201510126Q
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 1508783
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 2281747
Estimated Expiration: ⤷ Sign Up

Patent: 2466253
Estimated Expiration: ⤷ Sign Up

Patent: 160045053
Estimated Expiration: ⤷ Sign Up

Patent: 210094140
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 49100
Estimated Expiration: ⤷ Sign Up

Patent: 1534357
Estimated Expiration: ⤷ Sign Up

Tunisia

Patent: 15000549
Estimated Expiration: ⤷ Sign Up

Ukraine

Patent: 7833
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201690036	СОСТАВ С ОТСРОЧЕННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЙ ГРАНУЛЫ ЦИСТЕАМИНА, И СПОСОБЫ ЕГО ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ	⤷ Sign Up
European Patent Office	2535044	Cysteamine bitartrate et cystamine a enrobage entérique (Enterically coated cysteamine bitartrate and cystamine)	⤷ Sign Up
European Patent Office	3659588	CYSTÉAMINE ENTÉROSOLUBLE ET SELS ASSOCIÉS (ENTERICALLY COATED CYSTEAMINE AND SALTS THEREOF)	⤷ Sign Up
European Patent Office	3010491	PRÉPARATION DE BILLES DE CYSTÉAMINE À LIBÉRATION RETARDÉE (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION)	⤷ Sign Up
Taiwan	I649100		⤷ Sign Up
South Africa	201508783	DELAYED RELEASE CYSTEAMINE BEAD FORMULATION	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PROCYSBI

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122014000023	Germany	⤷ Sign Up	PRODUCT NAME: CYSTEAMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/861 20130906
1919458	2014C/018	Belgium	⤷ Sign Up	PRODUCT NAME: CYSTEAMINE; AUTHORISATION NUMBER AND DATE: EU/1/13/861 20130910
1919458	C01919458/01	Switzerland	⤷ Sign Up	PRODUCT NAME: MERCAPTAMIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67129 16.08.2019
1919458	CR 2014 00013	Denmark	⤷ Sign Up	PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906
1919458	19/2014	Austria	⤷ Sign Up	PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description