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
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.
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 | 200045-001 | 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 | |||
| >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 |
| >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 |
|---|---|---|---|
| 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 |
| Japan | 2015091830 | 有機化合物のガレヌス製剤 (GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS) | ⤷ Try a Trial |
| Canada | 2736257 | FORMULATIONS GALENIQUES DE COMPOSES ORGANIQUES (GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS) | ⤷ 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 |
|---|---|---|---|---|
| 1915993 | 132013902215595 | Italy | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E AMLODIPINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILAMLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/686/001-056, 20110414 |
| 2305232 | 132019000000150 | Italy | ⤷ Try a Trial | 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 | ⤷ Try a Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
