AMLODIPINE BESYLATE; CELECOXIB - Generic Drug Details
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What are the generic drug sources for amlodipine besylate; celecoxib and what is the scope of patent protection?
Amlodipine besylate; celecoxib
is the generic ingredient in one branded drug marketed by Purple Biotech and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Amlodipine besylate; celecoxib has nine patent family members in seven countries.
Summary for AMLODIPINE BESYLATE; CELECOXIB
International Patents: | 9 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Clinical Trials: | 3 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AMLODIPINE BESYLATE; CELECOXIB |
DailyMed Link: | AMLODIPINE BESYLATE; CELECOXIB at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AMLODIPINE BESYLATE; CELECOXIB
Generic Entry Date for AMLODIPINE BESYLATE; CELECOXIB*:
Constraining patent/regulatory exclusivity:
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 AMLODIPINE BESYLATE; CELECOXIB
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Alphacait, LLC | Phase 2 |
Kitov Pharma Ltd | Phase 3 |
Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; CELECOXIB
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 AMLODIPINE BESYLATE; CELECOXIB
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 | 210045-003 | May 31, 2018 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Purple Biotech | CONSENSI | amlodipine besylate; celecoxib | TABLET;ORAL | 210045-003 | May 31, 2018 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 AMLODIPINE BESYLATE; CELECOXIB
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2009154944 | ⤷ Try a Trial | |
Mexico | 2010012836 | FORMULACIONES FARMACEUTICAS Y METODOS DE USO QUE COMBINAN COMPUESTOS ANTIINFLAMATORIOS NO ESTEROIDES CON COMPUESTOS ANTIHIPERTENSIVOS. (PHARMACEUTICAL FORMULATIONS AND METHODS OF USE WHICH COMBINE NON-STEROIDAL ANTI-INFLAMMATORY COMPOUNDS WITH ANTI-HYPERTENSIVE COMPOUNDS.) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2019008583 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMLODIPINE BESYLATE; CELECOXIB
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 |
1507558 | C300528 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705 |
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 |