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
*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
| 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 | 202331-002 | 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 | 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 | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-001 | Dec 20, 2011 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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; 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 |
|---|---|---|---|
| Eurasian Patent Organization | 016593 | ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ПРОИЗВОДНОЕ БЕНЗИМИДАЗОЛ-7-КАРБОКСИЛАТА И pH РЕГУЛИРУЮЩИЙ АГЕНТ (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT) | ⤷ Sign Up |
| Peru | 20090550 | COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN DERIVADO DE BENCIMIDAZOL Y UN AGENTE DE CONTROL DE PH | ⤷ Sign Up |
| Chile | 2011000187 | Preparacion farmaceutica que comprende (5-metil-2-oxo-1,3-dioxol-4il)metil 2-etoxi-1-{[2,{5-oxo-4,5-dihidro-1,2,4-oxadiazol-3-il)bifenil4il]metil}-1h-benzimidazol-7-carboxilato, un agente de control de ph entre 2 y 5 y un diuretico; metodo para estabilizar; metodo para mejorar disolucion, util en enfermedades inducidas por angiotensina ii. | ⤷ Sign Up |
| Russian Federation | 2501798 | ПРОИЗВОДНОЕ БЕНЗИМИДАЗОЛА И ЕГО ПРИМЕНЕНИЕ (BENZIMIDAZOLE DERIVATIVE AND USE THEREOF) | ⤷ Sign Up |
| Tunisia | 2011000045 | SOLID PHARMACEUTICAL COMPOSITION | ⤷ 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 | PA2012004,C1718641 | Lithuania | ⤷ Sign Up | 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 | 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 | C20120005 00053 | Estonia | ⤷ Sign Up | PRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011 |
| 1718641 | 1290016-3 | Sweden | ⤷ Sign Up | PRODUCT NAME: AZILSARTANMEDOXOMIL OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV, INKLUDERANDE KALIUMSALT; REG. NO/DATE: EU/1/11/735/001 20111207 |
| 1718641 | PA2012004 | Lithuania | ⤷ Sign Up | 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 |
| >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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