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Quinapril hydrochloride - Generic Drug Details
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What are the generic sources for quinapril hydrochloride and what is the scope of freedom to operate?
Quinapril hydrochloride
is the generic ingredient in two branded drugs marketed by Pfizer Pharms, Actavis Elizabeth, Actavis Labs Fl Inc, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Invagen Pharms, Lupin, Mylan, Prinston Inc, Sun Pharm Inds Ltd, and Yaopharma Co Ltd, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.There are eleven drug master file entries for quinapril hydrochloride. There is one tentative approval for this compound.
Summary for quinapril hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 12 |
| NDAs: | 14 |
| Drug Master File Entries: | 11 |
| Bulk Api Vendors: | 66 |
| Clinical Trials: | 26 |
| Patent Applications: | 2,510 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | quinapril hydrochloride at DailyMed |
Recent Clinical Trials for quinapril hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Nebraska | Phase 4 |
| Pfizer | N/A |
| The University of Western Australia | Phase 3 |
Generic filers with tentative approvals for QUINAPRIL HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 40MG BASE | TABLET;ORAL |
| Start Trial | Start Trial | EQ 20MG BASE | TABLET;ORAL |
| Start Trial | Start Trial | EQ 10MG BASE | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Paragraph IV (Patent) Challenges for QUINAPRIL HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ACCUPRIL | TABLET;ORAL | quinapril hydrochloride | 019885 |
US Patents and Regulatory Information for quinapril hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Elizabeth | QUINAPRIL HYDROCHLORIDE | quinapril hydrochloride | TABLET;ORAL | 076459-003 | Dec 22, 2004 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Ani Pharms Inc | QUINAPRIL HYDROCHLORIDE | quinapril hydrochloride | TABLET;ORAL | 075504-004 | Aug 24, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sun Pharm Inds Ltd | QUINAPRIL HYDROCHLORIDE | quinapril hydrochloride | TABLET;ORAL | 090800-004 | Jun 18, 2009 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Actavis Labs Fl Inc | QUINAPRIL HYDROCHLORIDE | quinapril hydrochloride | TABLET;ORAL | 076049-001 | Jan 14, 2005 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sun Pharm Inds Ltd | QUINAPRIL HYDROCHLORIDE | quinapril hydrochloride | TABLET;ORAL | 090800-003 | Jun 18, 2009 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >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 quinapril hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer Pharms | ACCUPRIL | quinapril hydrochloride | TABLET;ORAL | 019885-004 | Nov 19, 1991 | Start Trial | Start Trial |
| Pfizer Pharms | ACCUPRIL | quinapril hydrochloride | TABLET;ORAL | 019885-001 | Nov 19, 1991 | Start Trial | Start Trial |
| Pfizer Pharms | ACCUPRIL | quinapril hydrochloride | TABLET;ORAL | 019885-004 | Nov 19, 1991 | Start Trial | Start Trial |
| Pfizer Pharms | ACCUPRIL | quinapril hydrochloride | TABLET;ORAL | 019885-004 | Nov 19, 1991 | Start Trial | Start Trial |
| Pfizer Pharms | ACCUPRIL | quinapril hydrochloride | TABLET;ORAL | 019885-003 | Nov 19, 1991 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
