AMLODIPINE BESYLATE; PERINDOPRIL ARGININE - Generic Drug Details
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What are the generic sources for amlodipine besylate; perindopril arginine and what is the scope of freedom to operate?
Amlodipine besylate; perindopril arginine
is the generic ingredient in one branded drug marketed by Adhera and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Amlodipine besylate; perindopril arginine has thirty patent family members in twenty-seven countries.
Summary for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
| International Patents: | 30 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE |
| DailyMed Link: | AMLODIPINE BESYLATE; PERINDOPRIL ARGININE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
*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; PERINDOPRIL ARGININE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Symplmed Pharmaceuticals LLC | Phase 3 |
See all AMLODIPINE BESYLATE; PERINDOPRIL ARGININE clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PRESTALIA | Tablets | amlodipine besylate; perindopril arginine | 3.5 mg/2.5 mg, 7 mg/5 mg and 14 mg/10 mg | 205003 | 1 | 2016-11-04 |
US Patents and Regulatory Information for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adhera | PRESTALIA | amlodipine besylate; perindopril arginine | TABLET;ORAL | 205003-001 | Jan 21, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Adhera | PRESTALIA | amlodipine besylate; perindopril arginine | TABLET;ORAL | 205003-003 | Jan 21, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Adhera | PRESTALIA | amlodipine besylate; perindopril arginine | TABLET;ORAL | 205003-002 | Jan 21, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | 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 |
Expired US Patents for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Adhera | PRESTALIA | amlodipine besylate; perindopril arginine | TABLET;ORAL | 205003-001 | Jan 21, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Adhera | PRESTALIA | amlodipine besylate; perindopril arginine | TABLET;ORAL | 205003-003 | Jan 21, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Adhera | PRESTALIA | amlodipine besylate; perindopril arginine | TABLET;ORAL | 205003-002 | Jan 21, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 1989182 | ⤷ Sign Up | |
| Croatia | P20160644 | ⤷ Sign Up | |
| European Patent Office | 1989182 | FORME CRISTALLINE DU SEL D'ARGININE DU PERINDOPRIL, SON PROCEDE DE PREPARATION, ET LES COMPOSITIONS PHARMACEUTIQUES QUI LA CONTIENNENT (CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT) | ⤷ Sign Up |
| Australia | 2007220435 | Alpha crystalline form of the arginine salt of perindopril, process for preparing it, and pharmaceutical compositions comprising it | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
