EDARBYCLOR Drug Patent Profile
✉ Email this page to a colleague
When do Edarbyclor patents expire, and when can generic versions of Edarbyclor launch?
Edarbyclor is a drug marketed by Azurity and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and seventeen patent family members in forty-four countries.
The generic ingredient in EDARBYCLOR is azilsartan kamedoxomil; chlorthalidone. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azilsartan kamedoxomil; chlorthalidone profile page.
DrugPatentWatch® Generic Entry Outlook for Edarbyclor
Edarbyclor was eligible for patent challenges on February 25, 2015.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 4, 2030. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for EDARBYCLOR?
- What are the global sales for EDARBYCLOR?
- What is Average Wholesale Price for EDARBYCLOR?
Summary for EDARBYCLOR
| International Patents: | 117 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 1 |
| Patent Applications: | 5 |
| Drug Prices: | Drug price information for EDARBYCLOR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EDARBYCLOR |
| What excipients (inactive ingredients) are in EDARBYCLOR? | EDARBYCLOR excipients list |
| DailyMed Link: | EDARBYCLOR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EDARBYCLOR
*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.
Recent Clinical Trials for EDARBYCLOR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Takeda | Phase 3 |
Pharmacology for EDARBYCLOR
| 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 EDARBYCLOR
| 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 EDARBYCLOR
EDARBYCLOR is protected by five US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of EDARBYCLOR is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting EDARBYCLOR
Benzimidazole derivative and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Benzimidazole derivative and use as a II receptor antagonist
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERTENSION
Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid pharmaceutical composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods of treating hypertension with at least one angiotensin II receptor blocker and chlorthalidone
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERTENSION
| 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 | ⤷ Sign Up | ||||
| 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 | 202331-001 | Dec 20, 2011 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-001 | Dec 20, 2011 | RX | Yes | No | ⤷ 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 EDARBYCLOR
| 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 EDARBYCLOR
When does loss-of-exclusivity occur for EDARBYCLOR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 2883
Patent: COMPOSICIoN FARMACÉUTICA SoLIDA CON EL COMPUESTO (5-METIL-2-OXO-1,3-DIOXOL-4-IL)METIL2-ETOXI-1-{[2' -(5-OXO-4,5-DIHIDRO-1,2,4-OXADIAZOL-3-IL)BIFENIL-4-IL]METIL}-1H-BENCIMIDAZOL-7-CARBOXILATO Y UN DIURÉTICO PARA LA PROFILAXIS O TRATAMIENTO DE ENFERMEDADES DEL APARATO CIRCULATORIO.
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 09277455
Patent: Solid pharmaceutical composition
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0916847
Patent: preparação sólida, e, métodos para estabilizar um composto e para melhorar a propriedade de dissolução de um composto.
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 32018
Patent: COMPOSITION PHARMACEUTIQUE SOLIDE (SOLID PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 11000187
Patent: 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.
Estimated Expiration: ⤷ Sign Up
China
Patent: 2164918
Patent: Solid pharmaceutical composition
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 41633
Patent: COMPOSICION FARMACEUTICA SOLIDA
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 110111
Patent: COMPOSICION FARMACEUTICA SOLIDA
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 011000032
Patent: COMPOSICION FARMACEUTICA SOLIDA
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 11010856
Patent: COMPOSICIÓN FARMACÉUTICA SÓLIDA
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 1170273
Patent: ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 10385
Patent: COMPOSITION PHARMACEUTIQUE SOLIDE (SOLID PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up
Georgia, Republic of
Patent: 0146062
Patent: SOLID PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 35491
Estimated Expiration: ⤷ Sign Up
Patent: 11529444
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 11001150
Patent: COMPOSICION FARMACEUTICA SOLIDA. (SOLID PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 553
Patent: تركيب صيدلاني صلب
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 0948
Patent: SOLID PHARMACEUTICAL COMPOSITION COMPRISING A DIURETIC, PH CONTROL AGENT AND AN OXADIAZOLE
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 110551
Patent: COMPOSICION FARMACEUTICA SOLIDA QUE CONTIENE UN DERIVADO DE BENCIMIDAZOL Y UN DIURETICO
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 10385
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1100871
Patent: SOLID PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 110038145
Patent: SOLID PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 1008915
Patent: Solid pharmaceutical composition
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 11000045
Patent: SOLID PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 3905
Patent: ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ;ТВЕРДА ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ (SOLID PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 017
Patent: COMPOSICIÓN FARMACÉUTICA SÓLIDA
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering EDARBYCLOR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Portugal | 2124903 | ⤷ Sign Up | |
| Australia | 2008235790 | Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent | ⤷ Sign Up |
| Argentina | 094588 | PROCESO DE OBTENCIÓN DE UN COMPUESTO DERIVADO DE BENZIMIDAZOL Y COMPOSICIÓN FARMACÉUTICA | ⤷ Sign Up |
| Japan | 2645962 | ⤷ Sign Up | |
| Hungary | 211162 | ⤷ Sign Up | |
| Canada | 2681143 | COMPOSITION PHARMACEUTIQUE SOLIDE COMPRENANT UN DERIVE DE BENZIMIDAZOLE-7-CARBOXYLATE ET UN AGENT DE CONTROLE DU PH (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EDARBYCLOR
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
