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 | 202331-001 | Dec 20, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-001 | Dec 20, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 | 32553 | تركيب صيدلاني صلب | ⤷ Try a Trial |
| South Africa | 201100871 | SOLID PHARMACEUTICAL COMPOSITION | ⤷ Try a Trial |
| South Korea | 20090125846 | SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT | ⤷ Try a Trial |
| Croatia | P20070510 | ⤷ Try a Trial | |
| Costa Rica | 20110111 | COMPOSICION FARMACEUTICA SOLIDA | ⤷ Try a Trial |
| Norway | 2012017 | ⤷ Try a Trial | |
| Georgia, Republic of | P20146062 | SOLID PHARMACEUTICAL COMPOSITION | ⤷ Try a Trial |
| >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 | 436 | Finland | ⤷ Try a Trial | |
| 1718641 | 12C0034 | France | ⤷ Try a Trial | PRODUCT NAME: AZILSARTAN MEDOXOMIL ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/735/001 20111207 |
| 1718641 | 132012902056823 | Italy | ⤷ Try a Trial | 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 | 121 5004-2012 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/735/011 20111207 |
| 1718641 | C 2012 017 | Romania | ⤷ Try a Trial | 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 | PA2012004,C1718641 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: AZILSARTANUM MEDOXOMILUM; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/734/011, 2011 12 07, EU/1/11/735/001 - EU/1/11/735/011 20111207 |
| 1718641 | 2012/008 | Ireland | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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