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Last Updated: September 25, 2022

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 six patents protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in six countries.

The generic ingredient in KATERZIA is amlodipine benzoate. There are fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amlodipine benzoate profile page.

DrugPatentWatch® Generic Entry Outlook for Katerzia

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 16, 2037. This may change due to patent challenges or generic licensing.

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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Summary for KATERZIA
International Patents:10
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 5
Patent Applications: 7
Drug Prices: Drug price information for KATERZIA
What excipients (inactive ingredients) are in KATERZIA?KATERZIA excipients list
DailyMed Link:KATERZIA at DailyMed
Drug patent expirations by year for KATERZIA
Drug Prices for KATERZIA

See drug prices for KATERZIA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for KATERZIA
Generic Entry Date for KATERZIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION;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.

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 eight US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KATERZIA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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 KATERZIA

Amlodipine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Amlodipine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Amlodipine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HYPERTENSION

Amlodipine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING HYPERTENSION

Amlodipine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Amlodipine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ANGINA PECTORIS

Amlodipine formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ANGINA


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

European Patent Office

Patent: 22872
Estimated Expiration: See Plans and Pricing

Patent: 60158
Estimated Expiration: See Plans and Pricing

Spain

Patent: 86067
Estimated Expiration: See Plans and Pricing

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) See Plans and Pricing
Japan 2021520367 アムロジピン製剤 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2018067959 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2019200143 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KATERZIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1915993 C300625 Netherlands See Plans and Pricing 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
0502314 C300478 Netherlands See Plans and Pricing 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
0678503 C300499 Netherlands See Plans and Pricing 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
0503785 CA 2011 00026 Denmark See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Colorcon
Baxter
McKesson
Boehringer Ingelheim
Medtronic

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.