Glimepiride; rosiglitazone maleate - Generic Drug Details
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What are the generic drug sources for glimepiride; rosiglitazone maleate and what is the scope of patent protection?
Glimepiride; rosiglitazone maleate
is the generic ingredient in two branded drugs marketed by Sb Pharmco and Teva Pharms Usa, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.Summary for glimepiride; rosiglitazone maleate
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Clinical Trials: | 1 |
| DailyMed Link: | glimepiride; rosiglitazone maleate at DailyMed |
Recent Clinical Trials for glimepiride; rosiglitazone maleate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| GlaxoSmithKline | Phase 3 |
| Canadian Heart Research Centre | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for glimepiride; rosiglitazone maleate
Paragraph IV (Patent) Challenges for GLIMEPIRIDE; ROSIGLITAZONE MALEATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AVANDARYL | Tablets | glimepiride; rosiglitazone maleate | 8 mg/2 mg 8 mg/4 mg | 021700 | 1 | 2008-05-30 |
| AVANDARYL | Tablets | glimepiride; rosiglitazone maleate | 1 mg/4 mg 2 mg/4 mg 4 mg/4 mg | 021700 | 1 | 2006-12-22 |
US Patents and Regulatory Information for glimepiride; rosiglitazone maleate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-003 | Nov 23, 2005 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Pharms Usa | ROSIGLITAZONE MALEATE AND GLIMEPIRIDE | glimepiride; rosiglitazone maleate | TABLET;ORAL | 078709-003 | Apr 1, 2016 | 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 | ||||
| Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-002 | Nov 23, 2005 | DISCN | Yes | 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; rosiglitazone maleate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-005 | Mar 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-005 | Mar 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-001 | Nov 23, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| Sb Pharmco | AVANDARYL | glimepiride; rosiglitazone maleate | TABLET;ORAL | 021700-002 | Nov 23, 2005 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
