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 | 206084-002 | Apr 26, 2017 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| 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 | ||||
| Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-003 | May 3, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-004 | May 3, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-001 | May 3, 2013 | DISCN | Yes | 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 | ||||
| >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 | 200153-004 | 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 |
| Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-001 | 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 | 200153-002 | May 3, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-002 | May 3, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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.
ISSN: 2162-2639
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