Aliskiren hemifumarate; amlodipine besylate - Generic Drug Details
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What are the generic sources for aliskiren hemifumarate; amlodipine besylate and what is the scope of freedom to operate?
Aliskiren hemifumarate; amlodipine besylate
is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Aliskiren hemifumarate; amlodipine besylate has twenty-three patent family members in twenty-one countries.
Summary for aliskiren hemifumarate; amlodipine besylate
| International Patents: | 23 |
| US Patents: | 1 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| DailyMed Link: | aliskiren hemifumarate; amlodipine besylate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for aliskiren hemifumarate; amlodipine besylate
Generic Entry Date for aliskiren hemifumarate; amlodipine besylate*:
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.
Anatomical Therapeutic Chemical (ATC) Classes for aliskiren hemifumarate; amlodipine besylate
US Patents and Regulatory Information for aliskiren hemifumarate; amlodipine besylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-004 | Dec 21, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-005 | Dec 21, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-003 | Dec 21, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-001 | Aug 26, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-003 | Aug 26, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-002 | Dec 21, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-001 | Dec 21, 2010 | DISCN | No | 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 |
Expired US Patents for aliskiren hemifumarate; amlodipine besylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-003 | Aug 26, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-001 | Aug 26, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-004 | Aug 26, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-002 | Aug 26, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for aliskiren hemifumarate; amlodipine besylate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20110060942 | FIXED DOSE COMBINATION IN FORM OF BILAYERED OR MONOLAYERED TABLET OF ALISKIREN AND AMLODIPINE | ⤷ Try a Trial |
| European Patent Office | 2328564 | FORMULATIONS GALÉNIQUES DE COMPOSÉS ORGANIQUES (FIXED DOSE COMBINATION IN FORM OF A BILAYERED OR MONOLAYERED TABLET OF ALISKIREN AND AMLODIPINE) | ⤷ Try a Trial |
| Colombia | 6351711 | COMBINACION DE DOSIS FIJA EN LA FORMA DE UNA TABLETA DE DOS COPAS O DE UNA SOLA CAPA DE ALISQUIRENO Y AMLODIPINA | ⤷ Try a Trial |
| Peru | 20110293 | COMBINACION DE DOSIS FIJA EN LA FORMA DE UNA TABLETA DE UNA SOLA CAPA QUE COMPRENDE ALISQUIRENO Y AMLODIPINA | ⤷ Try a Trial |
| Ecuador | SP11010999 | COMBINACIÓN DE DOSIS FIJA EN LA FORMA DE UNA TABLETA DE DOS CAPAS O DE UNA SOLA CAPA DE ALISQUIRENO Y AMLODIPINA | ⤷ Try a Trial |
| Taiwan | 201016217 | Galenical formulations of organic compounds | ⤷ Try a Trial |
| China | 102159195 | Dual-layer or monolayer form fixed dose combination of aliskiren and amlodipine | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for aliskiren hemifumarate; amlodipine besylate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0678503 | 07C0055 | France | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822 |
| 1915993 | 2013C/068 | Belgium | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON COMPRENANT L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET L'AMLOPINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/11/686/001 20110415 |
| 1507558 | CR 2012 00018 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, AMLODIPIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG HYDROCHLORTHIAZID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: EU/1/11/730/001-060 20111122; FIRST REG. NO/DATE: CH 61678 01-05 20110705 |
| 1915993 | 13C0063 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON COMPRENANT DE L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET DE L'ALMODIPINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/686/001 20110414 |
| 1915993 | 92315 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE |
| 1507558 | 18/2012 | Austria | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - 060 20111122; FIRST REGISTRATION: LI 61678 01-61678 05 20110705 |
| 0678503 | C00678503/04 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
