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 ten 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.
Summary for Apgdi
| International Patents: | 105 |
| US Patents: | 10 |
| 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 | 202611-001 | Jun 28, 2012 | AB | RX | Yes | Yes | 8,772,315*PED | ⤷ Subscribe | Y | ⤷ Subscribe | ||
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-001 | Jun 28, 2012 | AB | RX | Yes | Yes | 10,842,780*PED | ⤷ Subscribe | Y | ⤷ Subscribe | ||
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | AB | RX | Yes | Yes | RE44872*PED | ⤷ Subscribe | ⤷ Subscribe | |||
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-001 | Jun 28, 2012 | AB | RX | Yes | Yes | 8,835,474*PED | ⤷ Subscribe | ⤷ Subscribe | |||
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | AB | RX | Yes | Yes | 11,707,451*PED | ⤷ Subscribe | Y | ⤷ Subscribe | ||
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-001 | Jun 28, 2012 | AB | RX | Yes | Yes | 12,059,409 | ⤷ Subscribe | Y | ⤷ Subscribe | ||
| Apgdi | MYRBETRIQ GRANULES | mirabegron | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 213801-001 | Mar 25, 2021 | RX | Yes | Yes | 7,342,117*PED | ⤷ Subscribe | ⤷ Subscribe | ||||
| >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 | ⤷ Subscribe |
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | 6,562,375 | ⤷ Subscribe |
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-001 | Jun 28, 2012 | 7,750,029 | ⤷ Subscribe |
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-001 | Jun 28, 2012 | 6,699,503 | ⤷ Subscribe |
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | 7,750,029 | ⤷ Subscribe |
| Apgdi | MYRBETRIQ | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 202611-002 | Jun 28, 2012 | 6,699,503 | ⤷ Subscribe |
| >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 |
|---|---|---|
| Turkey | 201802207 | ⤷ Subscribe |
| Japan | WO2011122524 | ⤷ Subscribe |
| Japan | WO2003037881 | ⤷ Subscribe |
| Serbia | 59626 | ⤷ Subscribe |
| China | 1711085 | ⤷ Subscribe |
| Russian Federation | 2005117367 | ⤷ Subscribe |
| World Intellectual Property Organization (WIPO) | 2016159267 | ⤷ Subscribe |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Apgdi Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1559427 | 300599 | Netherlands | ⤷ Subscribe | PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20130107 |
| 1028111 | 300598 | Netherlands | ⤷ Subscribe | PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220 |
| 1028111 | CA 2013 00029 | Denmark | ⤷ Subscribe | PRODUCT NAME: MIRABEGRON OR SALTS THEREOF; REG. NO/DATE: EU/1/12/809/001-014 20121220 |
| 1559427 | 168 5014-2013 | Slovakia | ⤷ Subscribe | PRODUCT NAME: MIRABEGRON; REGISTRATION NO/DATE: EU/1/12/809/001 - EU/1/12/809/014 20121220 |
| 1559427 | C300599 | Netherlands | ⤷ Subscribe | PRODUCT NAME: MIRABEGRON EN ZOUTEN ERVAN; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220 |
| 1559427 | 33/2013 | Austria | ⤷ Subscribe | PRODUCT NAME: MIRABEGRON ODER DESSEN SALZE; REGISTRATION NO/DATE: EU/1/12/809/001-014 20121220 |
| 1559427 | SPC/GB13/035 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: MIRABEGRON OR A SALT THEREOF; REGISTERED: UK EU/1/12/809/001-014 20130107 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
