Azilsartan kamedoxomil; chlorthalidone - Generic Drug Details
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What are the generic drug sources for azilsartan kamedoxomil; chlorthalidone and what is the scope of patent protection?
Azilsartan kamedoxomil; chlorthalidone
is the generic ingredient in one branded drug marketed by Azurity and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Azilsartan kamedoxomil; chlorthalidone has one hundred and seventeen patent family members in forty-four countries.
Two suppliers are listed for this compound.
Summary for azilsartan kamedoxomil; chlorthalidone
International Patents: | 117 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for azilsartan kamedoxomil; chlorthalidone |
DailyMed Link: | azilsartan kamedoxomil; chlorthalidone at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for azilsartan kamedoxomil; chlorthalidone
Generic Entry Date for azilsartan kamedoxomil; chlorthalidone*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for azilsartan kamedoxomil; chlorthalidone
Drug Class | Angiotensin 2 Receptor Blocker Thiazide-like Diuretic |
Mechanism of Action | Angiotensin 2 Type 1 Receptor Antagonists |
Physiological Effect | Decreased Blood Pressure Increased Diuresis |
Paragraph IV (Patent) Challenges for AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EDARBYCLOR | Tablets | azilsartan kamedoxomil; chlorthalidone | 40 mg/12.5 mg and 40 mg/25 mg | 202331 | 1 | 2022-04-19 |
US Patents and Regulatory Information for azilsartan kamedoxomil; chlorthalidone
Expired US Patents for azilsartan kamedoxomil; chlorthalidone
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-001 | Dec 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-001 | Dec 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for azilsartan kamedoxomil; chlorthalidone
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Morocco | 28478 | DERIVE DU BENZIMIDAZOLE ET SES UTILISATIONS | ⤷ Sign Up |
Denmark | 1718641 | ⤷ Sign Up | |
Cyprus | 1107008 | ⤷ Sign Up | |
Spain | 2743784 | ⤷ Sign Up | |
Israel | 177533 | BENZIMIDAZOLE DERIVATIVES, THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEM | ⤷ Sign Up |
European Patent Office | 2310385 | COMPOSITION PHARMACEUTIQUE SOLIDE (SOLID PHARMACEUTICAL COMPOSITION) | ⤷ Sign Up |
Slovenia | 1718641 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for azilsartan kamedoxomil; chlorthalidone
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1718641 | 12C0034 | France | ⤷ Sign Up | PRODUCT NAME: AZILSARTAN MEDOXOMIL ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/735/001 20111207 |
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 |
1718641 | CA 2012 00013 | Denmark | ⤷ Sign Up | |
1718641 | 121 5004-2012 | Slovakia | ⤷ Sign Up | PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/735/011 20111207 |
1718641 | 2012/008 | Ireland | ⤷ Sign Up | PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTRATION NO/DATE: EU/1/11/734/001-011 EU/1/11/735/001-011 20111209 |
1718641 | 132012902056823 | Italy | ⤷ Sign Up | PRODUCT NAME: AZILSARTAN MEDOXOMIL(EDARBI E IPREZIV); AUTHORISATION NUMBER(S) AND DATE(S): EDARBI: DA EU/1/11/734/001 A EU/1/11/734/011; IPREZIV: DA EU/1/11/735/001 A EU/1/11/735/011, 20111207 |
1718641 | C20120004 00052 | Estonia | ⤷ Sign Up | PRODUCT NAME: EDARBI - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9280 FINAL 07.12.2011 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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