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Last Updated: August 15, 2022

ROSZET Drug Patent Profile


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

Roszet is a drug marketed by Althera Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has ten patent family members in nine countries.

The generic ingredient in ROSZET is ezetimibe; rosuvastatin calcium. There are twenty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ezetimibe; rosuvastatin calcium profile page.

DrugPatentWatch® Generic Entry Outlook for Roszet

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 1, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ROSZET
International Patents:10
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in ROSZET?ROSZET excipients list
DailyMed Link:ROSZET at DailyMed
Drug patent expirations by year for ROSZET
DrugPatentWatch® Estimated Generic Entry Opportunity Date for ROSZET
Generic Entry Date for ROSZET*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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.

US Patents and Regulatory Information for ROSZET

ROSZET is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ROSZET 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 ROSZET

Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERLIPIDEMIA

Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERLIPIDEMIA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Althera Pharms ROSZET ezetimibe; rosuvastatin calcium TABLET;ORAL 213072-001 Mar 23, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Althera Pharms ROSZET ezetimibe; rosuvastatin calcium TABLET;ORAL 213072-004 Mar 23, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Althera Pharms ROSZET ezetimibe; rosuvastatin calcium TABLET;ORAL 213072-002 Mar 23, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Althera Pharms ROSZET ezetimibe; rosuvastatin calcium TABLET;ORAL 213072-004 Mar 23, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Althera Pharms ROSZET ezetimibe; rosuvastatin calcium TABLET;ORAL 213072-001 Mar 23, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Althera Pharms ROSZET ezetimibe; rosuvastatin calcium TABLET;ORAL 213072-002 Mar 23, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Althera Pharms ROSZET ezetimibe; rosuvastatin calcium TABLET;ORAL 213072-003 Mar 23, 2021 RX Yes No 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 ROSZET

When does loss-of-exclusivity occur for ROSZET?

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

Denmark

Patent: 44233
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 44233
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 52300
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 5046
Estimated Expiration: See Plans and Pricing

Patent: 14013241
Estimated Expiration: See Plans and Pricing

Poland

Patent: 44233
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 44233
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 44233
Estimated Expiration: See Plans and Pricing

Spain

Patent: 02252
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 ROSZET around the world.

Country Patent Number Title Estimated Expiration
Spain 2802252 See Plans and Pricing
European Patent Office 2844233 FORMULATION DE COMPRIMÉ ORAL CONSTITUÉE D'UNE COMBINAISON FIXE DE ROSUVASTATINE ET D'ÉZÉTIMIBE POUR LE TRAITEMENT DE L'HYPERLIPIDÉMIE ET DE MALADIES CARDIOVASCULAIRES (ORAL TABLET FORMULATION CONSISTING OF FIXED COMBINATION OF ROSUVASTATIN AND EZETIMIBE FOR TREATMENT OF HYPERLIPIDEMIA AND CARDIOVASCULAR DISEASES) See Plans and Pricing
Portugal 2844233 See Plans and Pricing
Mexico 2014013241 FORMULACION DE TABLETA ORAL QUE CONSISTE DE UNA COMBINACION FIJA DE ROSUVASTATINA Y EZETIMIBA PARA EL TRATAMIENTO DE HIPERLIPIDEMIA Y ENFERMEDADES CARDIOVASCULARES. (ORAL TABLET FORMULATION CONSISTING OF FIXED COMBINATION OF ROSUVASTATIN AND EZETIMIBE FOR TREATMENT OF HYPERLIPIDEMIA AND CARDIOVASCULAR DISEASES.) See Plans and Pricing
Hungary E052300 See Plans and Pricing
Poland 2844233 See Plans and Pricing
Denmark 2844233 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ROSZET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 03C0028 France See Plans and Pricing PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017
0720599 05C0040 France See Plans and Pricing PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
Colorcon
Merck
Johnson and Johnson
McKesson

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.