Glimepiride - Generic Drug Details
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What are the generic drug sources for glimepiride and what is the scope of freedom to operate?
Glimepiride
is 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, Norvium Bioscience, 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
US Patents: | 2 |
Tradenames: | 6 |
Applicants: | 22 |
NDAs: | 22 |
Drug Master File Entries: | 16 |
Finished Product Suppliers / Packagers: | 31 |
Raw Ingredient (Bulk) Api Vendors: | 154 |
Clinical Trials: | 231 |
Patent Applications: | 6,945 |
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
Sponsor | Phase |
---|---|
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
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 2MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 1MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 8MG | 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.
Pharmacology for glimepiride
Drug Class | Sulfonylurea |
Anatomical Therapeutic Chemical (ATC) Classes for glimepiride
US Patents and Regulatory Information for glimepiride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | GLIMEPIRIDE | glimepiride | TABLET;ORAL | 077486-001 | Feb 10, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Teva Pharms Usa | ROSIGLITAZONE MALEATE AND GLIMEPIRIDE | glimepiride; rosiglitazone maleate | TABLET;ORAL | 078709-001 | Apr 1, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Watson Labs | GLIMEPIRIDE | glimepiride | TABLET;ORAL | 077280-003 | Feb 3, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ranbaxy | GLIMEPIRIDE | glimepiride | TABLET;ORAL | 077366-002 | Oct 6, 2005 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Epic Pharma Llc | GLIMEPIRIDE | glimepiride | TABLET;ORAL | 077274-003 | Oct 6, 2005 | DISCN | 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 |
Expired US Patents 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 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-003 | Nov 30, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | AMARYL | glimepiride | TABLET;ORAL | 020496-002 | Nov 30, 1995 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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