EDARBYCLOR Drug Patent Profile
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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. One supplier is 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
Summary for EDARBYCLOR
International Patents: | 117 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 1 |
Patent Applications: | 20 |
Formulation / Manufacturing: | see details |
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
Generic Entry Date for EDARBYCLOR*:
Constraining patent/regulatory exclusivity:
NDA:
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.
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Benzimidazole derivative and use as a II receptor antagonist
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERTENSION
Solid pharmaceutical composition comprising a benzimidazole-7-carboxylate derivative and a pH control agent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Solid pharmaceutical composition
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods of treating hypertension with at least one angiotensin II receptor blocker and chlorthalidone
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-001 | Dec 20, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 | 202331-001 | 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 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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 09277455
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0916847
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 32018
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 11000187
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2164918
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 41633
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 110111
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 011000032
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 11010856
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1170273
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 10385
Estimated Expiration: ⤷ Try a Trial
Georgia, Republic of
Patent: 0146062
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 35491
Estimated Expiration: ⤷ Try a Trial
Patent: 11529444
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 11001150
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 553
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 0948
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 110551
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 10385
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1100871
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 110038145
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 1008915
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 11000045
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 3905
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 017
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Japan | 2011529444 | ⤷ Try a Trial | |
Montenegro | 01643 | DERIVATI BENZIMIDAZOLA I NJIHOVO KORIŠĆENJE KAO ANTAGONISTA RECEPTORA A II (BENZIMIDAZOLE DERIVATIVE AND USE AS AII RECEPTOR ANTAGONIST) | ⤷ Try a Trial |
China | 101381366 | Benzimidazole derivative and its use as a ii receptor antagonist | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EDARBYCLOR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2119715 | 2018/006 | Ireland | ⤷ Try a Trial | 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 | CA 2012 00013 | Denmark | ⤷ Try a Trial | |
1718641 | PA2012004 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |