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Last Updated: March 28, 2024

Apgdi Company Profile


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Summary for Apgdi
International Patents:105
US Patents:8
Tradenames:2
Ingredients:1
NDAs:2

Drugs and US Patents for Apgdi

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 AB RX Yes Yes 11,707,451*PED ⤷  Try a Trial Y ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 AB RX Yes Yes 7,342,117*PED ⤷  Try a Trial ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 AB RX Yes Yes 10,842,780*PED ⤷  Try a Trial Y ⤷  Try a Trial
Apgdi MYRBETRIQ GRANULES mirabegron FOR SUSPENSION, EXTENDED RELEASE;ORAL 213801-001 Mar 25, 2021 RX Yes Yes 7,982,049*PED ⤷  Try a Trial ⤷  Try a Trial
Apgdi MYRBETRIQ GRANULES mirabegron FOR SUSPENSION, EXTENDED RELEASE;ORAL 213801-001 Mar 25, 2021 RX Yes Yes 10,058,536*PED ⤷  Try a Trial Y ⤷  Try a 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 Apgdi

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 6,562,375 ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 6,699,503 ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 7,750,029 ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-002 Jun 28, 2012 6,562,375 ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 6,699,503 ⤷  Try a Trial
Apgdi MYRBETRIQ mirabegron TABLET, EXTENDED RELEASE;ORAL 202611-001 Jun 28, 2012 7,750,029 ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for APGDI drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 25 mg and 50 mg ➤ Subscribe 2016-06-28

Supplementary Protection Certificates for Apgdi Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1559427 C 2013 020 Romania ⤷  Try a Trial PRODUCT NAME: MIRABEGRON SAU O SARE A ACESTUIA(2-(2-AMINO-1,3-TRIAZOL-4-IL)-N-[4-(2-{[(2R)-2-HIDROXI9/014; DATE OF NATIONAL AUTHORISATION: 20121220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/809/001 - EU/1/12/809/014; DATE OF FIRST AUTHORISATION IN EEA: 20121220 -2-FENILETIL]AMINO}ETIL)FENIL]ACETAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/12/809/001 - EU/1/12/80
1559427 C20130015 00094 Estonia ⤷  Try a Trial PRODUCT NAME: MIRABEGROON;REG NO/DATE: K(2012)9945 (LOPLIK) 20.12.2012
1559427 132013902166933 Italy ⤷  Try a Trial PRODUCT NAME: MIRABEGRON(BETMIGA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/809/014, 20121220
1559427 92218 Luxembourg ⤷  Try a Trial PRODUCT NAME: MIRABEGRON OU UN DE SES SELS
1559427 CA 2013 00028 Denmark ⤷  Try a Trial
1559427 1390028-7 Sweden ⤷  Try a Trial PRODUCT NAME: MIRABEGRON ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/12/809/001 20121220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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