REPAGLINIDE Drug Patent Profile
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When do Repaglinide patents expire, and when can generic versions of Repaglinide launch?
Repaglinide is a drug marketed by Actavis Totowa, Aurobindo Pharma Ltd, Chartwell Rx, Kenton, Macleods Pharms Ltd, Norvium Bioscience, Padagis Us, Sun Pharm Inds Inc, and Lupin Ltd. and is included in nine NDAs.
The generic ingredient in REPAGLINIDE is metformin hydrochloride; repaglinide. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.
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Summary for REPAGLINIDE
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 117 |
| Clinical Trials: | 66 |
| Patent Applications: | 4,310 |
| Drug Prices: | Drug price information for REPAGLINIDE |
| DailyMed Link: | REPAGLINIDE at DailyMed |
Recent Clinical Trials for REPAGLINIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Phase 1 |
| Pfizer | Phase 1 |
| Eli Lilly and Company | Phase 1 |
Pharmacology for REPAGLINIDE
| Drug Class | Glinide |
| Mechanism of Action | Potassium Channel Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for REPAGLINIDE
Paragraph IV (Patent) Challenges for REPAGLINIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PRANDIN | Tablets | repaglinide | 0.5 mg*, 1 mg and 2 mg | 020741 | 1 | 2005-02-10 |
US Patents and Regulatory Information for REPAGLINIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Totowa | REPAGLINIDE | repaglinide | TABLET;ORAL | 090008-001 | Jan 22, 2014 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | REPAGLINIDE | repaglinide | TABLET;ORAL | 090252-003 | Jan 22, 2014 | DISCN | No | 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 | ||||
| Chartwell Rx | REPAGLINIDE | repaglinide | TABLET;ORAL | 078555-001 | Nov 22, 2013 | AB | RX | 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 |
EU/EMA Drug Approvals for REPAGLINIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Accord Healthcare S.L.U. | Repaglinide Accord | repaglinide | EMEA/H/C/002318 Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals. |
Authorised | yes | no | no | 2011-12-22 | |
| Teva Pharma B.V. | Repaglinide Teva | repaglinide | EMEA/H/C/001067 Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2-diabetes patients who are not satisfactorily controlled on metformin alone.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals. |
Authorised | yes | no | no | 2009-06-28 | |
| Krka, d.d., Novo mesto | Repaglinide Krka | repaglinide | EMEA/H/C/001066 Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals. |
Authorised | yes | no | no | 2009-11-03 | |
| Krka, d.d., Novo mesto | Enyglid | repaglinide | EMEA/H/C/001065 Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone.Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals. |
Authorised | yes | no | no | 2009-10-13 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
