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Last Updated: April 26, 2024

Aliskiren hemifumarate - Generic Drug Details

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What are the generic drug sources for aliskiren hemifumarate and what is the scope of freedom to operate?

Aliskiren hemifumarate is the generic ingredient in six branded drugs marketed by Noden Pharma, Anchen Pharms, 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:	239
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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Noden Pharma	TEKTURNA	aliskiren hemifumarate	CAPSULE, PELLET;ORAL	210709-001	Nov 14, 2017		DISCN	Yes	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	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ 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
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008		DISCN	Yes	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

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

International Patents for aliskiren hemifumarate

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Country	Patent Number	Title	Estimated Expiration
Malaysia	148773	GALENIC FORMULATIONS OF ORGANIC COMPOUNDS	⤷ Try a Trial
Russian Federation	2480210	ТВЕРДАЯ ПЕРОРАЛЬНАЯ ЛЕКАРСТВЕННАЯ ФОРМА И СПОСОБ ЛЕЧЕНИЯ (ORAL SOLID DOSAGE FORM AND METHOD OF TREATING)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2005089729		⤷ Try a Trial
Singapore	153830	GALENIC FORMULATIONS OF ORGANIC COMPOUNDS	⤷ Try a Trial
Argentina	048431	FORMULACIONES GALENICAS DE COMPUESTOS ORGANICOS	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for aliskiren hemifumarate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	300625	Netherlands	⤷ Try a Trial	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
1602370	CA 2009 00010	Denmark	⤷ Try a Trial	PRODUCT NAME: ALISKIREN, SOM DETS FRIE BASE ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, SAMT HYDROCHLORTHIAZID ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, HERUNDER ALISKIREN HEMIFUMARAT OG HYDROCHLORTHIAZID; NAT. REG. NO/DATE: EU/1/08/491/001-080 20090116; FIRST REG. NO/DATE: CH 58935 01-04 20081028
0678503	C00678503/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007
1507558	C300528	Netherlands	⤷ Try a Trial	PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
0678503	07C0055	France	⤷ Try a Trial	PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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