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Generated: June 23, 2017
What are the generic drug sources for enalapril maleate and what is the scope of enalapril maleate freedom to operate?
Enalapril maleate is the generic ingredient in seven branded drugs marketed by Watson Labs, Silvergate Pharms, Sandoz Inc, Sandoz, Sun Pharm Inds Ltd, Taro, Krka Dd Novo Mesto, Mylan, Apotex, Teva, Ivax Sub Teva Pharms, Apothecon, Wockhardt Usa, Valeant Pharms North, Astrazeneca, Dr Reddys Labs Ltd, Upsher-smith Labs, Valeant Intl, G And W Labs Inc, Apotex Inc, and Taro Pharm Inds, and is included in twenty-eight NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 7 |
| Patents: | 4 |
| Applicants: | 21 |
| NDAs: | 28 |
| Drug Master File Entries: see list | 27 |
| Suppliers / Packagers: see list | 40 |
| Bulk Api Vendors: see list | 68 |
| Clinical Trials: see list | 275 |
| Patent Applications: see list | 6,521 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | enalapril maleate at DailyMed |
| Drug Class | Angiotensin Converting Enzyme Inhibitor |
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Decreased Blood Pressure |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apothecon | ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075583-001 | Aug 22, 2000 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Taro Pharm Inds | ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE | enalapril maleate; hydrochlorothiazide | TABLET;ORAL | 075788-002 | Sep 18, 2001 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Apothecon | ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075583-003 | Aug 22, 2000 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Krka Dd Novo Mesto | ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075369-002 | Aug 22, 2000 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Ivax Sub Teva Pharms | ENALAPRIL MALEATE | enalapril maleate | TABLET;ORAL | 075482-003 | Aug 22, 2000 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Valeant Pharms North | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-003 | Dec 24, 1985 | 4,374,829*PED | ► Subscribe | ||||||||||||||||||||||
Valeant Pharms North | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-005 | Jul 26, 1988 | 4,374,829*PED | ► Subscribe | ||||||||||||||||||||||
Valeant Pharms North | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-002 | Dec 24, 1985 | 4,374,829*PED | ► Subscribe | ||||||||||||||||||||||
Valeant Pharms North | VASOTEC | enalapril maleate | TABLET;ORAL | 018998-001 | Dec 24, 1985 | 4,374,829*PED | ► Subscribe | ||||||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2014055667 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2887379 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2903690 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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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 verifification 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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