KATERZIA Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Katerzia, and what generic alternatives are available?
Katerzia is a drug marketed by Azurity and is included in one NDA. There are eleven 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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for KATERZIA?
- What are the global sales for KATERZIA?
- What is Average Wholesale Price for KATERZIA?
Summary for KATERZIA
| International Patents: | 11 |
| US Patents: | 11 |
| 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 |
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 fifteen US patents.
Patents protecting KATERZIA
Amlodipine formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Amlodipine formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Amlodipine formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERTENSION
Amlodipine formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING HYPERTENSION
Amlodipine formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Amlodipine formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ANGINA PECTORIS
Amlodipine formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ANGINA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING CORONARY ARTERY DISEASE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING HYPERTENSION
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING CORONARY ARTERY DISEASE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ||||
| 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 | |||
| >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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2019200143 | ⤷ Sign Up | |
| Canada | 3038989 | FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) | ⤷ Sign Up |
| Canada | 3096101 | FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) | ⤷ Sign Up |
| China | 112334134 | 氨氯地平制剂 (AMLODIPINE FORMULATIONS) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2018067959 | ⤷ Sign Up | |
| European Patent Office | 3960158 | FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS) | ⤷ Sign Up |
| Japan | 7456933 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KATERZIA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1507558 | 2012/018 | Ireland | ⤷ Sign Up | PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705 |
| 0443983 | C300445 | Netherlands | ⤷ Sign Up | PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016 |
| 0503785 | C300375 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819 |
| 1915993 | C300625 | Netherlands | ⤷ Sign Up | 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 |
| 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 | C300478 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007 |
| 0443983 | 2007C/043 | Belgium | ⤷ Sign Up | PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222 |
| >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:
