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PRANDIN Drug Profile
» See Plans and Pricing
When do Prandin patents expire, and what generic alternatives are available?
Prandin is a drug marketed by Gemini Labs Llc and is included in one NDA.
The generic ingredient in PRANDIN is repaglinide. There are sixteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the repaglinide profile page.
US ANDA Litigation and Generic Entry Outlook for Prandin
A generic version of PRANDIN was approved as repaglinide by SUN PHARM INDS INC on July 11th, 2013.
Summary for PRANDIN
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Bulk Api Vendors: | 104 |
Patent Applications: | 4,053 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PRANDIN |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PRANDIN |
What excipients (inactive ingredients) are in PRANDIN? | PRANDIN excipients list |
DailyMed Link: | PRANDIN at DailyMed |


Paragraph IV (Patent) Challenges for PRANDIN
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
PRANDIN | TABLET;ORAL | repaglinide | 020741 | 2005-02-10 |
US Patents and Regulatory Information for PRANDIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-001 | Dec 22, 1997 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-002 | Dec 22, 1997 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-003 | Dec 22, 1997 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
>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 PRANDIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-003 | Dec 22, 1997 | Start Trial | Start Trial |
Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-003 | Dec 22, 1997 | Start Trial | Start Trial |
Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-002 | Dec 22, 1997 | Start Trial | Start Trial |
Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-001 | Dec 22, 1997 | Start Trial | Start Trial |
Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-001 | Dec 22, 1997 | Start Trial | Start Trial |
Gemini Labs Llc | PRANDIN | repaglinide | TABLET;ORAL | 020741-003 | Dec 22, 1997 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PRANDIN
Country | Patent Number | Estimated Expiration |
---|---|---|
Spain | 2159184 | Start Trial |
Spain | 8605500 | Start Trial |
Portugal | 82832 | Start Trial |
Israel | 73963 | Start Trial |
Luxembourg | 90301 | Start Trial |
Greece | 861558 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PRANDIN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0147850 | SPC/GB98/042 | United Kingdom | Start Trial | PRODUCT NAME: 2-ETHOXY-4-(1-(2-PIPERIDINO-PHENYL)-3-METHYL-1-BUTYL)-AMINOCARBONYLMETHYL)-BENZOIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT AND/OR OPTIONALLY IN THE FORM OF AN ENANTIOMER, IN PARTICULAR (S)(+)-2-ETHOXY-4-(1-(2-PIPERIDINO-PHENYL)-3; REGISTERED: UK EU/1/98/076/001 19980817; UK EU/1/98/076/002 19980817; UK EU/1/98/076/003 19980817; UK EU/1/98/076/004 19980817; UK EU/1/98/076/005 19980817; UK EU/1/98/076/006 19980817; UK EU/1/98/076/019 19980817; UK EU/1/98/076/020 19980817; UK EU/1/98/076/021 19980817; UK EU/1/98/076/013 19980817; UK EU/1/98/076/014 19980817; UK EU/1/98/076/015 19980817; UK EU/1/98/076/016 19980817; UK EU/1/98/076/017 19980817; UK EU/1/98/ |
0147850 | 99C0002 | Belgium | Start Trial | PRODUCT NAME: REPAGLINIDE; REGISTRATION NO/DATE: EU/1/98/076/001 19980817 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |