ENALAPRIL MALEATE - Generic Drug Details
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What are the generic sources for enalapril maleate and what is the scope of freedom to operate?
Enalapril maleate
is the generic ingredient in seven branded drugs marketed by Azurity, Alkem Labs Ltd, Amneal, Annora Pharma, Aurobindo Pharma, Bionpharma, Aiping Pharm Inc, Apothecon, Aurobindo Pharma Usa, Beximco Pharms Usa, Chartwell Rx, Heritage Pharma, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Prinston Inc, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Unique Pharm, Watson Labs, Wockhardt Ltd, Bausch, Astrazeneca, Cosette, Dr Reddys Labs Ltd, Nostrum Labs Inc, Rising, and Taro Pharm Inds, and is included in thirty-five NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Enalapril maleate has eight patent family members in five countries.
There are eighteen drug master file entries for enalapril maleate. Thirty-five suppliers are listed for this compound.
Summary for ENALAPRIL MALEATE
International Patents: | 8 |
US Patents: | 13 |
Tradenames: | 7 |
Applicants: | 29 |
NDAs: | 35 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 35 |
Raw Ingredient (Bulk) Api Vendors: | 83 |
Clinical Trials: | 16 |
Patent Applications: | 5,287 |
Drug Prices: | Drug price trends for ENALAPRIL MALEATE |
Drug Sales Revenues: | Drug sales revenues for ENALAPRIL MALEATE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ENALAPRIL MALEATE |
What excipients (inactive ingredients) are in ENALAPRIL MALEATE? | ENALAPRIL MALEATE excipients list |
DailyMed Link: | ENALAPRIL MALEATE at DailyMed |
Recent Clinical Trials for ENALAPRIL MALEATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Manchester University NHS Foundation Trust | Phase 2 |
University of Durham | Phase 3 |
Newcastle-upon-Tyne Hospitals NHS Trust | Phase 3 |
Pharmacology for ENALAPRIL MALEATE
Drug Class | Angiotensin Converting Enzyme Inhibitor |
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for ENALAPRIL MALEATE
Anatomical Therapeutic Chemical (ATC) Classes for ENALAPRIL MALEATE
Paragraph IV (Patent) Challenges for ENALAPRIL MALEATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EPANED | Oral Solution | enalapril maleate | 1 mg/mL | 208686 | 1 | 2018-08-31 |
EPANED KIT | Powder for Oral Solution | enalapril maleate | 1 mg/mL | 204308 | 1 | 2016-06-21 |
US Patents and Regulatory Information for ENALAPRIL MALEATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz Inc | ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075496-002 | Aug 22, 2000 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma Usa | ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075480-001 | Aug 22, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Unique Pharm | ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 218531-004 | Sep 19, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Apothecon | ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075583-004 | Aug 22, 2000 | DISCN | 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 |
Expired US Patents for ENALAPRIL MALEATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-005 | Jul 26, 1988 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-003 | Dec 24, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-002 | Dec 24, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-001 | Dec 24, 1985 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ENALAPRIL MALEATE
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 ENALAPRIL MALEATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3429581 | FORMULATIONS D'ÉNALAPRIL (ENALAPRIL FORMULATIONS) | ⤷ Sign Up |
Spain | 2770403 | ⤷ 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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