Apgdi Company Profile
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What is the competitive landscape for APGDI, and when can generic versions of APGDI drugs launch?
APGDI has two approved drugs.
There are eight US patents protecting APGDI drugs.
There are one hundred and five patent family members on APGDI drugs in thirty-one countries and twenty-one supplementary protection certificates in sixteen countries.
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 |
International Patents for Apgdi Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 03037881 | ⤷ Try a Trial |
European Patent Office | 3827826 | ⤷ Try a Trial |
Japan | 3800220 | ⤷ Try a Trial |
Russian Federation | 2321401 | ⤷ Try a Trial |
Denmark | 2345410 | ⤷ Try a Trial |
Taiwan | I322805 | ⤷ Try a Trial |
>Country | >Patent Number | >Estimated Expiration |
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
Here is a list of applicants with similar names.