Aliskiren hemifumarate; amlodipine besylate - Generic Drug Details

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

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

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

C09XA	Renin-inhibitors
C09X	OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

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
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-001	Dec 21, 2010		DISCN	No	No
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-001	Aug 26, 2010		DISCN	No	No			Y
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-003	Aug 26, 2010		DISCN	No	No			Y
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-003	Dec 21, 2010		DISCN	No	No
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-002	Dec 21, 2010		DISCN	No	No

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
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-001	Aug 26, 2010
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-004	Aug 26, 2010
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-002	Aug 26, 2010

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
Japan	2015091830	有機化合物のガレヌス製剤 (GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS)
Canada	2736257	FORMULATIONS GALENIQUES DE COMPOSES ORGANIQUES (GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS)
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.)
Malaysia	153610	FIXED DOSE COMBINATION IN FORM OF A BILAYERED OR MONOLAYERED TABLET OF ALISKIREN AND AMLODIPINE
Tunisia	2011000100	GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS

Supplementary Protection Certificates for aliskiren hemifumarate; amlodipine besylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	132013902215595	Italy		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		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		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
1507558	CR 2012 00018	Denmark		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	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0678503	SPC/GB07/060	United Kingdom		PRODUCT NAME: ALISKIREN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/405/001 20070822; UK EU/1/04/405/002 20070822; UK EU/1/04/405/003 20070822; UK EU/1/04/405/004 20070822; UK EU/1/04/405/005 20070822; UK EU/1/04/405/006 20070822; UK EU/1/04/405/007 20070822; UK EU/1/04/405/008 20070822; UK EU/1/04/405/009 20070822; UK EU/1/04/405/010 20070822; UK EU/1/04/405/011 20070822; UK EU/1/04/405/012 20070822; UK EU/1/04/405/013 20070822; UK EU/1/04/405/014 20070822; UK EU/1/04/405/015 20070822; UK EU/1/04/405/016 20070822; UK EU/1/04/405/017 20070822; UK EU/1/04/405/018 20070822; UK EU/1/04/405/019 20070822; UK EU/1/04/405/020 20070822