Aliskiren hemifumarate - Generic Drug Details

What are the generic drug sources for aliskiren hemifumarate and what is the scope of patent protection?

Aliskiren hemifumarate is the generic ingredient in six branded drugs marketed by Noden Pharma, Endo Operations, and Novartis, and is included in seven NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate has forty patent family members in twenty-two countries.

There are four drug master file entries for aliskiren hemifumarate. Four suppliers are listed for this compound.

Summary for aliskiren hemifumarate

International Patents:	40
US Patents:	4
Tradenames:	6
Applicants:	3
NDAs:	7
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	63
Patent Applications:	215
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aliskiren hemifumarate
What excipients (inactive ingredients) are in aliskiren hemifumarate?	aliskiren hemifumarate excipients list
DailyMed Link:	aliskiren hemifumarate at DailyMed

Pharmacology for aliskiren hemifumarate

Drug Class	Renin Inhibitor
Mechanism of Action	Renin Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for aliskiren hemifumarate

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

Paragraph IV (Patent) Challenges for ALISKIREN HEMIFUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TEKTURNA	Tablets	aliskiren hemifumarate	150 mg and 300 mg	021985	1	2014-01-27

US Patents and Regulatory Information for aliskiren hemifumarate

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	200045-002	Dec 21, 2010		DISCN	No	No
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008		DISCN	Yes	No			Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008		DISCN	Yes	No			Y
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007	AB	RX	Yes	No					Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008		DISCN	Yes	No			Y
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010		DISCN	No	No

Expired US Patents for aliskiren hemifumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007

International Patents for aliskiren hemifumarate

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2384328	ГАЛЕНОВЫ СОСТАВЫ ОРГАНИЧЕСКИХ СОЕДИНЕНИЙ (HALENIC COMPOSITIONS OF ORGANIC COMPOUNDS)
South Africa	200606220	GALENIC FORMULATIONS OF ORGANIC COMPOUNDS
Norway	20064670
Malaysia	148773	GALENIC FORMULATIONS OF ORGANIC COMPOUNDS
Malaysia	144477	GALENIC FORMULATIONS OF ORGANIC COMPOUNDS
Spain	2747941

Supplementary Protection Certificates for aliskiren hemifumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	1390055-0	Sweden		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		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
1915993	300625	Netherlands		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		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		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