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Glimepirideis the generic ingredient in six branded drugs marketed by Sanofi Aventis Us, Accord Hlthcare, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Carlsbad, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Pharms, Indoco Remedies, Invagen Pharms, Micro Labs, Mylan, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Teva, Watson Labs, Takeda Pharms Usa, Sandoz, Sb Pharmco, and Teva Pharms Usa, and is included in twenty-two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.
There are sixteen drug master file entries for glimepiride. Thirty-five suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for glimepiride
|Drug Master File Entries:||16|
|Suppliers / Packagers:||35|
|Bulk Api Vendors:||118|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for glimepiride|
|Drug Sales Revenues:||Drug sales revenues for glimepiride|
|DailyMed Link:||glimepiride at DailyMed|
Recent Clinical Trials for glimepiride
Identify potential brand extensions & 505(b)(2) entrants
|Rehab Werida||Phase 4|
Generic filers with tentative approvals for GLIMEPIRIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for glimepiride
|Drug Class||Sulfonylurea |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Sanofi Aventis Us||AMARYL||glimepiride||TABLET;ORAL||020496-001||Nov 30, 1995||Start Trial||Start Trial|
|Sanofi Aventis Us||AMARYL||glimepiride||TABLET;ORAL||020496-002||Nov 30, 1995||Start Trial||Start Trial|
|Sanofi Aventis Us||AMARYL||glimepiride||TABLET;ORAL||020496-003||Nov 30, 1995||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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