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 nine 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
Summary for KATERZIA
International Patents: | 11 |
US Patents: | 9 |
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 |
Pharmacology for KATERZIA
Drug Class | Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker |
Mechanism of Action | Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for KATERZIA
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 twelve US patents.
Patents protecting KATERZIA
Amlodipine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Amlodipine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Amlodipine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF HYPERTENSION
Amlodipine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING HYPERTENSION
Amlodipine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Amlodipine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ANGINA PECTORIS
Amlodipine formulations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ANGINA
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING CORONARY ARTERY DISEASE
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING HYPERTENSION
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | KATERZIA | amlodipine benzoate | SUSPENSION;ORAL | 211340-001 | Jul 8, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Azurity | KATERZIA | amlodipine benzoate | SUSPENSION;ORAL | 211340-001 | Jul 8, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Azurity | KATERZIA | amlodipine benzoate | SUSPENSION;ORAL | 211340-001 | Jul 8, 2019 | RX | Yes | Yes | ⤷ 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 |
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
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 22872
Estimated Expiration: ⤷ Try a Trial
Patent: 60158
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 86067
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 KATERZIA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 112334134 | 氨氯地平制剂 (AMLODIPINE FORMULATIONS) | ⤷ Try a Trial |
Japan | 2021520367 | アムロジピン製剤 | ⤷ Try a Trial |
European Patent Office | 3522872 | FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KATERZIA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0443983 | 2007C/043 | Belgium | ⤷ Try a Trial | PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222 |
1915993 | C300625 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414 |
0678503 | C300499 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |