Atorvastatin calcium; ezetimibe - Generic Drug Details
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What are the generic sources for atorvastatin calcium; ezetimibe and what is the scope of patent protection?
Atorvastatin calcium; ezetimibe
is the generic ingredient in two branded drugs marketed by Organon and Althera Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for atorvastatin calcium; ezetimibe
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 3 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for atorvastatin calcium; ezetimibe |
DailyMed Link: | atorvastatin calcium; ezetimibe at DailyMed |
Recent Clinical Trials for atorvastatin calcium; ezetimibe
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Chong Kun Dang Pharmaceutical | Phase 1 |
Merck Sharp & Dohme Corp. | Phase 3 |
Pharmacology for atorvastatin calcium; ezetimibe
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 atorvastatin calcium; ezetimibe
US Patents and Regulatory Information for atorvastatin calcium; ezetimibe
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Althera Pharms | LYPQOZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 206084-004 | Apr 26, 2017 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-002 | May 3, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Althera Pharms | LYPQOZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 206084-002 | Apr 26, 2017 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Althera Pharms | LYPQOZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 206084-003 | Apr 26, 2017 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-003 | May 3, 2013 | DISCN | Yes | No | ⤷ 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 |
Expired US Patents for atorvastatin calcium; ezetimibe
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-001 | May 3, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-003 | May 3, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-001 | May 3, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-004 | May 3, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-003 | May 3, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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