EPANED Drug Patent Profile
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When do Epaned patents expire, and when can generic versions of Epaned launch?
Epaned is a drug marketed by Azurity and is included in two NDAs. There are thirteen patents protecting this drug and one Paragraph IV challenge.
This drug has three patent family members in three countries.
The generic ingredient in EPANED is enalapril maleate. There are twenty-seven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the enalapril maleate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Epaned
A generic version of EPANED was approved as enalapril maleate by HERITAGE PHARMA on August 22nd, 2000.
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Summary for EPANED
| International Patents: | 3 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 83 |
| Patent Applications: | 3,999 |
| Drug Prices: | Drug price information for EPANED |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPANED |
| What excipients (inactive ingredients) are in EPANED? | EPANED excipients list |
| DailyMed Link: | EPANED at DailyMed |
Pharmacology for EPANED
| Drug Class | Angiotensin Converting Enzyme Inhibitor |
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Decreased Blood Pressure |
Paragraph IV (Patent) Challenges for EPANED
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| EPANED | Oral Solution | enalapril maleate | 1 mg/mL | 208686 | 1 | 2018-08-31 |
US Patents and Regulatory Information for EPANED
EPANED is protected by seventeen US patents.
Patents protecting EPANED
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERTENSION
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING HYPERTENSION
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATMENT OF HEART FAILURE
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HEART FAILURE
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATMENT OF HEART FAILURE
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HEART FAILURE
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING HYPERTENSION
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION
Enalapril formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERTENSION
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Azurity | EPANED KIT | enalapril maleate | FOR SOLUTION;ORAL | 204308-001 | Aug 13, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Azurity | EPANED KIT | enalapril maleate | FOR SOLUTION;ORAL | 204308-001 | Aug 13, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Azurity | EPANED | enalapril maleate | SOLUTION;ORAL | 208686-001 | Sep 20, 2016 | AB | RX | Yes | Yes | ⤷ 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 |
EU/EMA Drug Approvals for EPANED
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Proveca Pharma Limited | Aqumeldi | Enalapril maleate | EMEA/H/C/005731 Treatment of heart failure. |
Authorised | no | no | no | 2023-11-15 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for EPANED
See the table below for patents covering EPANED around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 3429581 | FORMULATIONS D'ÉNALAPRIL (ENALAPRIL FORMULATIONS) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2017161339 | ⤷ Sign Up | |
| Brazil | 112018068960 | formulações de enalapril | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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