KATERZIA Drug Patent Profile
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Which patents cover Katerzia, and when can generic versions of Katerzia launch?
Katerzia is a drug marketed by Azurity and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has eleven patent family members in six countries.
The generic ingredient in KATERZIA is amlodipine benzoate. There are fifty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amlodipine benzoate profile page.
DrugPatentWatch® Generic Entry Outlook for Katerzia
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for KATERZIA?
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Summary for KATERZIA
International Patents: | 11 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 9 |
Patent Applications: | 9 |
Drug Prices: | Drug price information for KATERZIA |
What excipients (inactive ingredients) are in KATERZIA? | KATERZIA excipients list |
DailyMed Link: | KATERZIA at DailyMed |
![KATERZIA drug patent expirations Drug patent expirations by year for KATERZIA](/p/graph/s/t/KATERZIA-patent-expirations.png)
![Drug Prices for KATERZIA](/p/graph/drug-price/KATERZIA.png)
Pharmacology for KATERZIA
Drug Class | Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker |
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Paragraph IV (Patent) Challenges for KATERZIA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
KATERZIA | Oral Suspension | amlodipine benzoate | 1 mg/mL | 211340 | 1 | 2020-12-29 |
US Patents and Regulatory Information for KATERZIA
KATERZIA is protected by fourteen US patents.
Patents protecting KATERZIA
Amlodipine formulations
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Amlodipine formulations
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Amlodipine formulations
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Patented Use: TREATMENT OF HYPERTENSION
Amlodipine formulations
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Patented Use: METHOD OF TREATING HYPERTENSION
Amlodipine formulations
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Amlodipine formulations
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Patented Use: ANGINA PECTORIS
Amlodipine formulations
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Patented Use: ANGINA
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Patented Use: A METHOD OF TREATING CORONARY ARTERY DISEASE
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Patented Use: A METHOD OF TREATING HYPERTENSION
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Patented Use: A METHOD OF TREATING CORONARY ARTERY DISEASE
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Patented Use: A METHOD OF TREATING HYPERTENSION
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Azurity | KATERZIA | amlodipine benzoate | SUSPENSION;ORAL | 211340-001 | Jul 8, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Azurity | KATERZIA | amlodipine benzoate | SUSPENSION;ORAL | 211340-001 | Jul 8, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Azurity | KATERZIA | amlodipine benzoate | SUSPENSION;ORAL | 211340-001 | Jul 8, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Azurity | KATERZIA | amlodipine benzoate | SUSPENSION;ORAL | 211340-001 | Jul 8, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Azurity | KATERZIA | amlodipine benzoate | SUSPENSION;ORAL | 211340-001 | Jul 8, 2019 | RX | Yes | Yes | ⤷ 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 |
International Patents for KATERZIA
When does loss-of-exclusivity occur for KATERZIA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Canada
Patent: 38989
Patent: FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 22872
Patent: FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 60158
Patent: FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 86067
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 KATERZIA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3522872 | FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2018067959 | ⤷ Sign Up | |
European Patent Office | 3960158 | FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) | ⤷ Sign Up |
Spain | 2886067 | ⤷ Sign Up | |
Canada | 3038989 | FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KATERZIA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0443983 | C00443983/03 | Switzerland | ⤷ Sign Up | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 |
1003503 | 05C0048 | France | ⤷ Sign Up | PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707 |
0503785 | CA 2011 00026 | Denmark | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216 |
0502314 | SPC/GB11/010 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK |
0503785 | C300486 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |