Apgdi Company Profile
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What is the competitive landscape for APGDI, and what generic alternatives to APGDI drugs are available?
APGDI has two approved drugs.
There are nine 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 | 202611-001 | Jun 28, 2012 | AB | RX | Yes | Yes | 8,772,315*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Apgdi | MYRBETRIQ GRANULES | mirabegron | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 213801-001 | Mar 25, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | |||||
Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | AB | RX | Yes | Yes | RE44872*PED | ⤷ Sign Up | ⤷ Sign Up | |||
Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-001 | Jun 28, 2012 | AB | RX | Yes | Yes | RE44872*PED | ⤷ Sign Up | ⤷ Sign Up | |||
Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | AB | RX | Yes | Yes | 10,842,780*PED | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Apgdi | MYRBETRIQ GRANULES | mirabegron | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 213801-001 | Mar 25, 2021 | RX | Yes | Yes | 10,058,536*PED | ⤷ Sign Up | Y | ⤷ 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 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 | ⤷ Sign Up |
Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | 6,562,375 | ⤷ Sign Up |
Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | 6,699,503 | ⤷ Sign Up |
Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | 7,750,029 | ⤷ Sign Up |
Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-001 | Jun 28, 2012 | 7,750,029 | ⤷ Sign Up |
Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-001 | Jun 28, 2012 | 6,699,503 | ⤷ Sign Up |
>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 |
---|---|---|
Hong Kong | 1216232 | ⤷ Sign Up |
Hungary | 230481 | ⤷ Sign Up |
Japan | 3815496 | ⤷ Sign Up |
Luxembourg | 92218 | ⤷ Sign Up |
Cyprus | 1113670 | ⤷ Sign Up |
Norway | 334948 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Apgdi Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1028111 | CA 2013 00029 | Denmark | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON OR SALTS THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220 |
1559427 | 1390028-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/12/809/001 20121220 |
1559427 | C 2013 020 | Romania | ⤷ Sign Up | 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 |
1028111 | C300598 | Netherlands | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220 |
1559427 | CA 2013 00028 | Denmark | ⤷ Sign Up | |
1559427 | 168 5014-2013 | Slovakia | ⤷ Sign Up | PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: EU/1/12/809/001 - EU/1/12/809/014 20121220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.