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Last Updated: May 19, 2022

PROCYSBI Drug Patent Profile


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

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

This drug has fifty-eight 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. One supplier is 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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Drug patent expirations by year for PROCYSBI
Drug Prices for PROCYSBI

See drug prices for PROCYSBI

DrugPatentWatch® Estimated Generic Entry Opportunity Date for PROCYSBI
Generic Entry Dates for PROCYSBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE, DELAYED RELEASE;ORAL
Generic Entry Dates for PROCYSBI*:
Constraining patent/regulatory exclusivity:
NDA:
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

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

See all PROCYSBI clinical trials

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 five FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PROCYSBI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES

Methods for storing cysteamine formulations and related methods of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES

Methods for storing Cysteamine formulations and related methods of treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES

Enterically coated cystamine, cysteamine and derivatives thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Delayed release cysteamine bead formulation, and methods of making and using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Delayed release cysteamine bead formulation, and methods of making and using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES

Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES

Enterically coated cysteamine, cystamine and derivatives thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES

FDA Regulatory Exclusivity protecting PROCYSBI

TO EXPAND THE INDICATION TO PEDIATRIC PATIENTS 2-6 YEARS OF AGE WITH NEPHROPATHIC CYSTINOSIS
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF NEPHROPATHIC CYSTINOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE TO LESS THAN 2 YEARS OF AGE
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

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: See Plans and Pricing

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 GRANULE, DELAYED RELEASE;ORAL 213491-001 Feb 14, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Horizon Pharma Usa PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-001 Feb 14, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon Pharma Usa PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Horizon Pharma Usa PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon Pharma Usa PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-001 Feb 14, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon Pharma Usa PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon Pharma Usa PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 14281702
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2015031417
Estimated Expiration: See Plans and Pricing

Canada

Patent: 14770
Estimated Expiration: See Plans and Pricing

Patent: 38644
Estimated Expiration: See Plans and Pricing

Chile

Patent: 15003662
Estimated Expiration: See Plans and Pricing

China

Patent: 5492000
Estimated Expiration: See Plans and Pricing

Patent: 0664780
Estimated Expiration: See Plans and Pricing

Cuba

Patent: 150178
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1255
Estimated Expiration: See Plans and Pricing

Patent: 1690036
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 10491
Estimated Expiration: See Plans and Pricing

Patent: 39574
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 18066
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4823
Estimated Expiration: See Plans and Pricing

Japan

Patent: 68661
Estimated Expiration: See Plans and Pricing

Patent: 16523250
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 15017366
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4517
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1500177
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 015502783
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201510126Q
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1508783
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2281747
Estimated Expiration: See Plans and Pricing

Patent: 160045053
Estimated Expiration: See Plans and Pricing

Patent: 210094140
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 49100
Estimated Expiration: See Plans and Pricing

Patent: 1534357
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 15000549
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 7833
Estimated Expiration: See Plans and Pricing

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
Cuba 20150178 FORMULACIÓN EN PERLAS DE CISTEAMINA DE LIBERACIÓN RETARDADA See Plans and Pricing
Mexico 2015017366 FORMULACION DE PERLAS DE CISTEAMINA DE LIBERACION RETARDADA. (DELAYED RELEASE CYSTEAMINE BEAD FORMULATION.) See Plans and Pricing
Eurasian Patent Organization 200801752 ПОКРЫТЫЕ ЭНТЕРОСОЛЮБИЛЬНОЙ ОБОЛОЧКОЙ ЦИСТЕАМИН И ЦИСТАМИН И ИХ ПРОИЗВОДНЫЕ See Plans and Pricing
Nicaragua 201500177 FORMULACIÓN EN PERLAS DE CISTEAMINA DE LIBERACIÓN RETARDADA See Plans and Pricing
Lithuania 2535044 See Plans and Pricing
Spain 2774755 See Plans and Pricing
Slovenia 1919458 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PROCYSBI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1919458 194 50001-2014 Slovakia See Plans and Pricing PRODUCT NAME: MERKAPTAMIN; FIRST REGISTRATION: EU/1/13/861, 20130906
1919458 300649 Netherlands See Plans and Pricing PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
1919458 CR 2014 00013 Denmark See Plans and Pricing PRODUCT NAME: CYSTEAMIN, HERUNDER MERCAPTAMINBITARTRAT; REG. NO/DATE: EU/1/13/861 20130906
1919458 SPC/GB14/019 United Kingdom See Plans and Pricing PRODUCT NAME: CYSTEAMINE; REGISTERED: UK EU/1/13/861 20130910
1919458 C01919458/01 Switzerland See Plans and Pricing PRODUCT NAME: MERCAPTAMIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67129 16.08.2019
1919458 19/2014 Austria See Plans and Pricing PRODUCT NAME: CYSTEAMIN; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130910
1919458 C300649 Netherlands See Plans and Pricing PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130906
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Moodys
Johnson and Johnson
McKinsey
Baxter

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.