EDARBI Drug Patent Profile
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When do Edarbi patents expire, and when can generic versions of Edarbi launch?
Edarbi is a drug marketed by Azurity and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has eighty-nine patent family members in thirty-six countries.
The generic ingredient in EDARBI is azilsartan kamedoxomil. 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 profile page.
DrugPatentWatch® Generic Entry Outlook for Edarbi
Edarbi was eligible for patent challenges on February 25, 2015.
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 EDARBI
International Patents: | 89 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 78 |
Clinical Trials: | 15 |
Patent Applications: | 300 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for EDARBI |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EDARBI |
What excipients (inactive ingredients) are in EDARBI? | EDARBI excipients list |
DailyMed Link: | EDARBI at DailyMed |
Recent Clinical Trials for EDARBI
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Takeda | |
Takeda | Phase 1 |
University of Chicago | N/A |
Pharmacology for EDARBI
Drug Class | Angiotensin 2 Receptor Blocker |
Mechanism of Action | Angiotensin 2 Type 1 Receptor Antagonists |
Physiological Effect | Decreased Blood Pressure |
Paragraph IV (Patent) Challenges for EDARBI
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EDARBI | Tablets | azilsartan kamedoxomil | 40 mg and 80 mg | 200796 | 1 | 2020-04-10 |
US Patents and Regulatory Information for EDARBI
EDARBI is protected by three US patents.
Patents protecting EDARBI
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-001 | Feb 25, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-002 | Feb 25, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-001 | Feb 25, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-001 | Feb 25, 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 EDARBI
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-001 | Feb 25, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-001 | Feb 25, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-002 | Feb 25, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
Azurity | EDARBI | azilsartan kamedoxomil | TABLET;ORAL | 200796-002 | Feb 25, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EDARBI
When does loss-of-exclusivity occur for EDARBI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 5850
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 08235790
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0809522
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 81143
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 08000868
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1677961
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 6593
Estimated Expiration: ⤷ Try a Trial
Patent: 0970896
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 24903
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 83632
Estimated Expiration: ⤷ Try a Trial
Patent: 10522692
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 09010167
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 9851
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 090550
Estimated Expiration: ⤷ Try a Trial
Patent: 130210
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 24903
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 090125846
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 43784
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 15634
Estimated Expiration: ⤷ Try a Trial
Patent: 0902089
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 EDARBI around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | 251288 | ⤷ Try a Trial | |
Poland | 2119715 | ⤷ Try a Trial | |
Russian Federation | 2501798 | ПРОИЗВОДНОЕ БЕНЗИМИДАЗОЛА И ЕГО ПРИМЕНЕНИЕ (BENZIMIDAZOLE DERIVATIVE AND USE THEREOF) | ⤷ Try a Trial |
Hungary | 9202135 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EDARBI
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 | SPC/GB12/028 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209 |
1718641 | C20120004 00052 | Estonia | ⤷ Try a Trial | PRODUCT NAME: EDARBI - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9280 FINAL 07.12.2011 |
1718641 | 91962 | Luxembourg | ⤷ Try a Trial | 91962, EXPIRES: 20261207 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |