REPAGLINIDE - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for repaglinide and what is the scope of patent protection?
Repaglinide
is the generic ingredient in two branded drugs marketed by Gemini Labs Llc, Actavis Totowa, Aurobindo Pharma Ltd, Chartwell Rx, Kenton, Macleods Pharms Ltd, Mylan, Padagis Us, and Sun Pharm Inds Inc, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There are sixteen drug master file entries for repaglinide. Seven suppliers are listed for this compound.
Summary for REPAGLINIDE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 9 |
NDAs: | 9 |
Drug Master File Entries: | 16 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 117 |
Clinical Trials: | 66 |
Patent Applications: | 7,892 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for REPAGLINIDE |
What excipients (inactive ingredients) are in REPAGLINIDE? | REPAGLINIDE excipients list |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Padagis Us | REPAGLINIDE | repaglinide | TABLET;ORAL | 201189-001 | Jul 17, 2013 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Kenton | REPAGLINIDE | repaglinide | TABLET;ORAL | 091517-003 | Apr 24, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Actavis Totowa | REPAGLINIDE | repaglinide | TABLET;ORAL | 090008-002 | Jan 22, 2014 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Mylan | REPAGLINIDE | repaglinide | TABLET;ORAL | 090252-003 | Jan 22, 2014 | 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 REPAGLINIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-001 | Dec 22, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-003 | Dec 22, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-003 | Dec 22, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-001 | Dec 22, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.