EZETIMIBE AND SIMVASTATIN Drug Patent Profile
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Which patents cover Ezetimibe And Simvastatin, and when can generic versions of Ezetimibe And Simvastatin launch?
Ezetimibe And Simvastatin is a drug marketed by Alkem Labs Ltd, Amneal Pharms Co, Ani Pharms, Aurobindo Pharma Usa, Dr Reddys Labs Sa, Glenmark Pharms Ltd, and Watson Labs Inc. and is included in seven NDAs.
The generic ingredient in EZETIMIBE AND SIMVASTATIN is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ezetimibe And Simvastatin
A generic version of EZETIMIBE AND SIMVASTATIN was approved as ezetimibe; simvastatin by DR REDDYS LABS SA on April 26th, 2017.
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Questions you can ask:
- What is the 5 year forecast for EZETIMIBE AND SIMVASTATIN?
- What are the global sales for EZETIMIBE AND SIMVASTATIN?
- What is Average Wholesale Price for EZETIMIBE AND SIMVASTATIN?
Summary for EZETIMIBE AND SIMVASTATIN
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 107 |
| Patent Applications: | 206 |
| DailyMed Link: | EZETIMIBE AND SIMVASTATIN at DailyMed |
Recent Clinical Trials for EZETIMIBE AND SIMVASTATIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The University of Hong Kong | Phase 4 |
| Cairo University | N/A |
| Aswan Heart Centre | N/A |
Pharmacology for EZETIMIBE AND SIMVASTATIN
| Drug Class | Dietary Cholesterol Absorption Inhibitor HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| Physiological Effect | Decreased Cholesterol Absorption |
US Patents and Regulatory Information for EZETIMIBE AND SIMVASTATIN
| 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 | 202968-004 | Apr 26, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 209222-001 | Dec 22, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys Labs Sa | EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 200909-002 | Apr 26, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glenmark Pharms Ltd | EZETIMIBE AND SIMVASTATIN | ezetimibe; simvastatin | TABLET;ORAL | 208699-004 | Jun 27, 2019 | AB | 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 |
