METFORMIN HYDROCHLORIDE; REPAGLINIDE - Generic Drug Details
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What are the generic drug sources for metformin hydrochloride; repaglinide and what is the scope of patent protection?
Metformin hydrochloride; repaglinide
is the generic ingredient in two branded drugs marketed by Novo Nordisk Inc and Lupin Ltd, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.Summary for METFORMIN HYDROCHLORIDE; REPAGLINIDE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Clinical Trials: | 22 |
| DailyMed Link: | METFORMIN HYDROCHLORIDE; REPAGLINIDE at DailyMed |
Recent Clinical Trials for METFORMIN HYDROCHLORIDE; REPAGLINIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medicines for Malaria Venture | Phase 1 |
| Novartis Pharmaceuticals | Phase 1 |
| AstraZeneca | Phase 2/Phase 3 |
See all METFORMIN HYDROCHLORIDE; REPAGLINIDE clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for METFORMIN HYDROCHLORIDE; REPAGLINIDE
Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; REPAGLINIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PRANDIMET | Tablets | metformin hydrochloride; repaglinide | 1 mg/500 mg and 2 mg/500 mg | 022386 | 1 | 2009-04-09 |
US Patents and Regulatory Information for METFORMIN HYDROCHLORIDE; REPAGLINIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-002 | Jun 23, 2008 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lupin Ltd | REPAGLINIDE AND METFORMIN HYDROCHLORIDE | metformin hydrochloride; repaglinide | TABLET;ORAL | 200624-001 | Jul 15, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lupin Ltd | REPAGLINIDE AND METFORMIN HYDROCHLORIDE | metformin hydrochloride; repaglinide | TABLET;ORAL | 200624-002 | Jul 15, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-001 | Jun 23, 2008 | 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 METFORMIN HYDROCHLORIDE; REPAGLINIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-001 | Jun 23, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-002 | Jun 23, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-002 | Jun 23, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Novo Nordisk Inc | PRANDIMET | metformin hydrochloride; repaglinide | TABLET;ORAL | 022386-001 | Jun 23, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
