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
*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 |
Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE; CELECOXIB
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 | 210045-003 | May 31, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Purple Biotech | CONSENSI | amlodipine besylate; celecoxib | TABLET;ORAL | 210045-003 | May 31, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Purple Biotech | CONSENSI | amlodipine besylate; celecoxib | TABLET;ORAL | 210045-001 | May 31, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Purple Biotech | CONSENSI | amlodipine besylate; celecoxib | TABLET;ORAL | 210045-003 | May 31, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Purple Biotech | CONSENSI | amlodipine besylate; celecoxib | TABLET;ORAL | 210045-002 | May 31, 2018 | DISCN | Yes | No | ⤷ 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 AMLODIPINE BESYLATE; CELECOXIB
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2011100659 | ⤷ Sign Up | |
| Japan | 2011525479 | ⤷ Sign Up | |
| China | 111065382 | 塞来昔布和氨氯地平的配方及其制备方法 (CELECOXIB AND AMLODIPINE FORMULATION AND METHOD OF MAKING THE SAME) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2009154944 | ⤷ Sign Up | |
| Australia | 2009260632 | Pharmaceutical formulations and methods of use which combine non-steroidal anti-inflammatory compounds with anti-hypertensive compounds | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMLODIPINE BESYLATE; CELECOXIB
| 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 |
| 1507558 | 12C0033 | France | ⤷ Sign Up | PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705 |
| 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 |
| 1003503 | 05C0048 | France | ⤷ Sign Up | PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707 |
| 0503785 | C300486 | Netherlands | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
