ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - Generic Drug Details
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What are the generic drug 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
*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 | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-004 | Aug 26, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-005 | Dec 21, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-002 | Dec 21, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-002 | Aug 26, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-003 | Aug 26, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-001 | Aug 26, 2010 | DISCN | No | 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 |
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 | 022545-001 | Aug 26, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-004 | Aug 26, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-003 | Aug 26, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TEKAMLO | aliskiren hemifumarate; amlodipine besylate | TABLET;ORAL | 022545-002 | Aug 26, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Jordan | 3239 | تركيبات جالينية من مركبات عضوية (Galenical Formulations of Organic Compounds) | ⤷ Sign Up |
| Malaysia | 153610 | FIXED DOSE COMBINATION IN FORM OF A BILAYERED OR MONOLAYERED TABLET OF ALISKIREN AND AMLODIPINE | ⤷ Sign Up |
| Peru | 20110293 | COMBINACION DE DOSIS FIJA EN LA FORMA DE UNA TABLETA DE UNA SOLA CAPA QUE COMPRENDE ALISQUIRENO Y AMLODIPINA | ⤷ Sign Up |
| Brazil | PI0919350 | combinação de dose fixa oral farmacêutica na forma de uma comprimido monocamada, bem como seu uso e seu método de preparação | ⤷ Sign Up |
| Mexico | 2011002988 | COMBINACION DE DOSIS FIJA EN LA FORMA DE UNA TABLETA DE DOS CAPAS O DE UNA SOLA CAPA DE ALISQUIRENO Y AMLODIPINA. (FIXED DOSE COMBINATION IN FORM OF A BILAYERED OR MONOLAYERED TABLET OF ALISKIREN AND AMLODIPINE.) | ⤷ Sign Up |
| Japan | 2015091830 | 有機化合物のガレヌス製剤 (GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS) | ⤷ Sign Up |
| >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 |
|---|---|---|---|---|
| 1915993 | 1390055-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: KOMBINATION INNEFATTANDE ALISKIREN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH AMLODIPIN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/11/686/001 20110414 |
| 2305232 | 132019000000150 | Italy | ⤷ Sign Up | PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E IDROCLOROTIAZIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/491, 20090120 |
| 1602370 | 11/2009 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: LI 58935 20081028 |
| 1915993 | 300625 | 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 |
| 1507558 | 122012000031 | Germany | ⤷ Sign Up | PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 1), AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 2) UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 3); NAT. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: SCHWEIZ 61678 01 - 05 20110705 |
| 0678503 | C300386 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE OMVATTENDE ALISKIREN, ALS VRIJE BASE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; NATL. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: CH 58935 01-04 20081028 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
