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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, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Pharms, Indoco Remedies, 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 two 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-one suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for glimepiride
|Drug Master File Entries:||16|
|Finished Product Suppliers / Packagers:||31|
|Raw Ingredient (Bulk) Api Vendors:||146|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for glimepiride|
|Drug Sales Revenues:||Drug sales revenues for glimepiride|
|What excipients (inactive ingredients) are in glimepiride?||glimepiride excipients list|
|DailyMed Link:||glimepiride at DailyMed|
Recent Clinical Trials for glimepiride
Identify potential brand extensions & 505(b)(2) entrants
|Jiangsu Province Geriatric Institute||Phase 4|
|Peking University People's Hospital||Phase 4|
|Peking University First Hospital||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 |
Anatomical Therapeutic Chemical (ATC) Classes for glimepiride
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Sanofi Aventis Us||AMARYL||glimepiride||TABLET;ORAL||020496-001||Nov 30, 1995||See Plans and Pricing||See Plans and Pricing|
|Sanofi Aventis Us||AMARYL||glimepiride||TABLET;ORAL||020496-002||Nov 30, 1995||See Plans and Pricing||See Plans and Pricing|
|Sanofi Aventis Us||AMARYL||glimepiride||TABLET;ORAL||020496-003||Nov 30, 1995||See Plans and Pricing||See Plans and Pricing|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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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 verification 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.