EZETIMIBE Drug Patent Profile
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When do Ezetimibe patents expire, and when can generic versions of Ezetimibe launch?
Ezetimibe is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Ohm Labs Inc, Orient Pharma, Rising, Sandoz, Sciegen Pharms Inc, Teva Pharms Usa, Watson Labs Inc, Zydus Pharms, Ani Pharms, Aurobindo Pharma Usa, and Dr Reddys Labs Sa. and is included in twenty-two NDAs.
The generic ingredient in EZETIMIBE is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ezetimibe
A generic version of EZETIMIBE was approved as ezetimibe; simvastatin by DR REDDYS LABS SA on April 26th, 2017.
Summary for EZETIMIBE
Recent Clinical Trials for EZETIMIBE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| dotter | Phase 4 |
| Novartis Pharmaceuticals | Phase 3 |
| Organon and Co | Phase 4 |
Pharmacology for EZETIMIBE
| Drug Class | Dietary Cholesterol Absorption Inhibitor |
| Physiological Effect | Decreased Cholesterol Absorption |
Medical Subject Heading (MeSH) Categories for EZETIMIBE
Anatomical Therapeutic Chemical (ATC) Classes for EZETIMIBE
US Patents and Regulatory Information for EZETIMIBE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs Inc | EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 202968-002 | Apr 26, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Dr Reddys Labs Sa | EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 200909-001 | Apr 26, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Aurobindo Pharma Usa | EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 200082-001 | Dec 17, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
