EPANED KIT Drug Patent Profile
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Which patents cover Epaned Kit, and what generic alternatives are available?
Epaned Kit is a drug marketed by Azurity and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.
This drug has five patent family members in five countries.
The generic ingredient in EPANED KIT 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 Kit
A generic version of EPANED KIT was approved as enalapril maleate by HERITAGE PHARMA on August 22nd, 2000.
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Summary for EPANED KIT
| International Patents: | 5 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 83 |
| Patent Applications: | 3,999 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EPANED KIT |
| DailyMed Link: | EPANED KIT at DailyMed |
Paragraph IV (Patent) Challenges for EPANED KIT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| EPANED KIT | Powder for Oral Solution | enalapril maleate | 1 mg/mL | 204308 | 1 | 2016-06-21 |
US Patents and Regulatory Information for EPANED KIT
EPANED KIT is protected by twelve US patents.
Patents protecting EPANED KIT
Enalapril compositions
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Patent Expiration: ⤷ Sign Up
Enalapril compositions
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Patented Use: TREATMENT OF HYPERTENSION
Enalapril compositions
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Patented Use: METHOD OF TREATMENT OF HEART FAILURE
Enalapril compositions
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Patented Use: METHOD OF TREATING HYPERTENSION
Enalapril compositions
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Patented Use: TREATMENT OF HEART FAILURE
Enalapril compositions
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Patented Use: METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION
Enalapril compositions
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Enalapril compositions
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Patented Use: METHOD OF TREATMENT OF HEART FAILURE
Enalapril compositions
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Patented Use: TREATMENT OF HYPERTENSION
Enalapril compositions
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Patented Use: METHOD OF TREATING LEFT VENTRICULAR DYSFUNCTION
Enalapril compositions
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Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING HYPERTENSION
Enalapril compositions
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Patented Use: TREATMENT OF HEART FAILURE
| 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 | ⤷ Sign Up | ||||
| Azurity | EPANED KIT | enalapril maleate | FOR SOLUTION;ORAL | 204308-001 | Aug 13, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 KIT | enalapril maleate | FOR SOLUTION;ORAL | 204308-001 | Aug 13, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 KIT
| 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 KIT
See the table below for patents covering EPANED KIT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2770403 | ⤷ Sign Up | |
| Canada | 2887379 | COMPOSITIONS D'ENALAPRIL (ENALAPRIL COMPOSITIONS) | ⤷ Sign Up |
| European Patent Office | 2903690 | COMPOSITIONS D'ÉNALAPRIL (ENALAPRIL COMPOSITIONS) | ⤷ Sign Up |
| Brazil | 112015007592 | composições de enalapril | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2014055667 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated 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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