ENALAPRIL MALEATE Drug Patent Profile
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When do Enalapril Maleate patents expire, and what generic alternatives are available?
Enalapril Maleate is a drug marketed by 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, Watson Labs, Wockhardt Ltd, Cosette, Dr Reddys Labs Ltd, Nostrum Labs Inc, Rising, and Taro Pharm Inds. and is included in twenty-nine NDAs.
The generic ingredient in ENALAPRIL MALEATE is enalapril maleate; hydrochlorothiazide. There are twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Enalapril Maleate
A generic version of ENALAPRIL MALEATE was approved as enalapril maleate; hydrochlorothiazide by TARO PHARM INDS on September 18th, 2001.
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Questions you can ask:
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Summary for ENALAPRIL MALEATE
| US Patents: | 0 |
| Applicants: | 25 |
| NDAs: | 29 |
| Finished Product Suppliers / Packagers: | 31 |
| Raw Ingredient (Bulk) Api Vendors: | 83 |
| Clinical Trials: | 16 |
| Patent Applications: | 3,999 |
| Drug Prices: | Drug price information 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 |
See drug prices for ENALAPRIL MALEATE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ivax Sub Teva Pharms | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | enalapril maleate; hydrochlorothiazide | TABLET;ORAL | 075736-001 | Mar 25, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075472-004 | Aug 22, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ivax Sub Teva Pharms | ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075482-003 | Aug 22, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz Inc | ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075459-002 | Aug 22, 2000 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs | ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075501-003 | Aug 22, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Prinston Inc | ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 213273-004 | Jul 7, 2022 | 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 |
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 |
