ROSZET Drug Patent Profile
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
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
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 |

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.
Pharmacology for ROSZET
Drug Class | Dietary Cholesterol Absorption Inhibitor HMG-CoA Reductase Inhibitor |
Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Physiological Effect | Decreased Cholesterol Absorption |
Anatomical Therapeutic Chemical (ATC) Classes for ROSZET
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
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 |