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Last Updated: March 28, 2024

CONSENSI Drug Patent Profile


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When do Consensi patents expire, and what generic alternatives are available?

Consensi is a drug marketed by Purple Biotech and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in seven countries.

The generic ingredient in CONSENSI is amlodipine besylate; celecoxib. There are fifty drug master file entries for this compound. Additional details are available on the amlodipine besylate; celecoxib profile page.

DrugPatentWatch® Generic Entry Outlook for Consensi

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 22, 2029. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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

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  Try a Trial

Summary for CONSENSI
International Patents:9
US Patents:5
Applicants:1
NDAs:1
Clinical Trials: 2
Formulation / Manufacturing:see details
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for CONSENSI
What excipients (inactive ingredients) are in CONSENSI?CONSENSI excipients list
DailyMed Link:CONSENSI at DailyMed
Drug patent expirations by year for CONSENSI
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CONSENSI
Generic Entry Date for CONSENSI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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.

Recent Clinical Trials for CONSENSI

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Kitov Pharma LtdPhase 3
Kitov Pharmaceuticals, Ltd.Phase 3

See all CONSENSI clinical trials

Paragraph IV (Patent) Challenges for CONSENSI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CONSENSI Tablets amlodipine besylate; celecoxib 2.5 mg/200 mg, 5 mg/200 mg, 10 mg/200 mg 210045 1 2020-06-29

US Patents and Regulatory Information for CONSENSI

CONSENSI is protected by five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CONSENSI is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  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.

Patents protecting CONSENSI

Celecoxib and amlodipine formulation and method of making the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Celecoxib and amlodipine formulation and method of making the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE

Celecoxib and amlodipine formulation and method of making the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Ameliorating drug-induced elevations in blood pressure by adjunctive use of antihypertensive drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE

Ameliorating drug-induced elevations in blood pressure by adjunctive use of antihypertensive drugs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Purple Biotech CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045-001 May 31, 2018 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Purple Biotech CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045-002 May 31, 2018 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Purple Biotech CONSENSI amlodipine besylate; celecoxib TABLET;ORAL 210045-001 May 31, 2018 DISCN 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

International Patents for CONSENSI

When does loss-of-exclusivity occur for CONSENSI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 09260632
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 26337
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 85371
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 11525479
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 10012836
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 CONSENSI around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2019008583 ⤷  Try a Trial
Canada 2726337 FORMULATIONS PHARMACEUTIQUES ET PROCEDES D'UTILISATION COMBINANT DES COMPOSES ANTIINFLAMMATOIRES NON STEROIDES ET DES COMPOSES ANTI-HYPERTENSIFS (PHARMACEUTICAL FORMULATIONS AND METHODS OF USE WHICH COMBINE NON-STEROIDAL ANTI-INFLAMMATORY COMPOUNDS WITH ANTI-HYPERTENSIVE COMPOUNDS) ⤷  Try a Trial
Australia 2009260632 Pharmaceutical formulations and methods of use which combine non-steroidal anti-inflammatory compounds with anti-hypertensive compounds ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CONSENSI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0503785 C300486 Netherlands ⤷  Try a Trial 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
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
0443983 C00443983/03 Switzerland ⤷  Try a Trial PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
>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.