EPLERENONE Drug Patent Profile
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When do Eplerenone patents expire, and what generic alternatives are available?
Eplerenone is a drug marketed by Accord Hlthcare, Annora Pharma, Breckenridge, Chartwell Rx, Prasco, Rising, Sandoz, Slate Run Pharma, and Westminster Pharms. and is included in nine NDAs.
The generic ingredient in EPLERENONE is eplerenone. There are five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the eplerenone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Eplerenone
A generic version of EPLERENONE was approved as eplerenone by CHARTWELL RX on July 30th, 2008.
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Questions you can ask:
- What is the 5 year forecast for EPLERENONE?
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- What is Average Wholesale Price for EPLERENONE?
Summary for EPLERENONE
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Clinical Trials: | 128 |
| Patent Applications: | 3,605 |
| Drug Prices: | Drug price information for EPLERENONE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPLERENONE |
| What excipients (inactive ingredients) are in EPLERENONE? | EPLERENONE excipients list |
| DailyMed Link: | EPLERENONE at DailyMed |
Recent Clinical Trials for EPLERENONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assiut University | Phase 4 |
| Mario Negri Institute for Pharmacological Research | Phase 3 |
| Vifor Pharma | Phase 3 |
Pharmacology for EPLERENONE
| Drug Class | Aldosterone Antagonist |
| Mechanism of Action | Aldosterone Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for EPLERENONE
Paragraph IV (Patent) Challenges for EPLERENONE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| INSPRA | Injection | eplerenone | 0.75 mg/mL, 100 mL vial | 021437 | 1 | 2009-06-05 |
| INSPRA | Tablets | eplerenone | 25 mg and 50 mg | 021437 | 2 | 2006-09-27 |
US Patents and Regulatory Information for EPLERENONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | EPLERENONE | eplerenone | TABLET;ORAL | 206922-001 | Jul 13, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Westminster Pharms | EPLERENONE | eplerenone | TABLET;ORAL | 207842-002 | Oct 25, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | EPLERENONE | eplerenone | TABLET;ORAL | 078482-001 | Jul 30, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Annora Pharma | EPLERENONE | eplerenone | TABLET;ORAL | 213812-002 | Jun 2, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | EPLERENONE | eplerenone | TABLET;ORAL | 214663-002 | Mar 23, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | EPLERENONE | eplerenone | TABLET;ORAL | 078482-002 | Jul 30, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Slate Run Pharma | EPLERENONE | eplerenone | TABLET;ORAL | 212765-002 | Aug 10, 2020 | 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 |
