AZILSARTAN KAMEDOXOMIL - Generic Drug Details
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What are the generic drug sources for azilsartan kamedoxomil and what is the scope of patent protection?
Azilsartan kamedoxomil
is the generic ingredient in three branded drugs marketed by Lupin Ltd and Azurity, and is included in three NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Azilsartan kamedoxomil has eighty-nine patent family members in thirty-six countries.
There are three drug master file entries for azilsartan kamedoxomil. One supplier is listed for this compound.
Summary for AZILSARTAN KAMEDOXOMIL
International Patents: | 89 |
US Patents: | 5 |
Tradenames: | 3 |
Applicants: | 2 |
NDAs: | 3 |
Drug Master File Entries: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 114 |
Patent Applications: | 798 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AZILSARTAN KAMEDOXOMIL |
What excipients (inactive ingredients) are in AZILSARTAN KAMEDOXOMIL? | AZILSARTAN KAMEDOXOMIL excipients list |
DailyMed Link: | AZILSARTAN KAMEDOXOMIL at DailyMed |
Pharmacology for AZILSARTAN KAMEDOXOMIL
Drug Class | Angiotensin 2 Receptor Blocker |
Mechanism of Action | Angiotensin 2 Type 1 Receptor Antagonists |
Physiological Effect | Decreased Blood Pressure |
Paragraph IV (Patent) Challenges for AZILSARTAN KAMEDOXOMIL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EDARBI | Tablets | azilsartan kamedoxomil | 40 mg and 80 mg | 200796 | 1 | 2020-04-10 |
US Patents and Regulatory Information for AZILSARTAN KAMEDOXOMIL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-001 | Dec 20, 2011 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-001 | Feb 25, 2011 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ 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 AZILSARTAN KAMEDOXOMIL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-002 | Feb 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-001 | Feb 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-002 | Feb 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-002 | Feb 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-001 | Feb 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AZILSARTAN KAMEDOXOMIL
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 1718641 | ⤷ Sign Up | |
Brazil | PI0507984 | composto ou um sal do mesmo, processo para produzir um composto, medicamento, métodos para antagonizar angiotensina ii em um mamìfero, para melhorar a resistência de insulina em um mamìfero e para prevenir ou tratar doenças circulatórias em um mamìfero, e, uso do composto | ⤷ Sign Up |
Hungary | S1200008 | ⤷ Sign Up | |
Spain | 2331209 | ⤷ Sign Up | |
Portugal | 1857457 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AZILSARTAN KAMEDOXOMIL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1718641 | C01718641/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012 |
1718641 | C 2012 017 | Romania | ⤷ Sign Up | PRODUCT NAME: AZILSARTAN MEDOXOMIL SI SARURI ACCEPTABILE FARMACEUTICALE ACESTUIA, INCLUZAND SAREA DEUTHORISATION: 20111207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/ POTASIU; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/734/001 - RO EU/1/11/734/011; DATE OF NATIONAL A734/001 - EMEA EU/1/11/734/011; DATE OF FIRST AUTHORISATION IN EEA: 20111207 |
2119715 | 2018/006 | Ireland | ⤷ Sign Up | PRODUCT NAME: COMBINATION OF AZILSARTAN MEDOXOMIL AND CHLORTALIDONE (EDARBYCLOR); NAT REGISTRATION NO/DATE: PA/2167/001/001-002 20170804; FIRST REGISTRATION NO/DATE: 63145 01-02 20141028 |
1718641 | 91962 | Luxembourg | ⤷ Sign Up | 91962, EXPIRES: 20261207 |
1718641 | 2012C/025 | Belgium | ⤷ Sign Up | PRODUCT NAME: AZILSARTAN MEDOXOMIL; AUTHORISATION NUMBER AND DATE: EU/1/11/734/001 20111209 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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