Aliskiren hemifumarate - Generic Drug Details
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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, 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 |
Anatomical Therapeutic Chemical (ATC) Classes for aliskiren hemifumarate
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
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 | ⤷ 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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2005089729 | ⤷ Try a Trial | |
South Korea | 101353736 | ⤷ Try a Trial | |
Japan | 2007529456 | ⤷ Try a Trial | |
European Patent Office | 1729736 | FORMULATIONS GALENIQUES DE COMPOSES ORGANIQUES (GALENIC FORMULATIONS OF ORGANIC COMPOUNDS) | ⤷ Try a Trial |
Russian Federation | 2384328 | ГАЛЕНОВЫ СОСТАВЫ ОРГАНИЧЕСКИХ СОЕДИНЕНИЙ (HALENIC COMPOSITIONS OF ORGANIC COMPOUNDS) | ⤷ Try a Trial |
Peru | 20060075 | COMPOSICIONES FARMACEUTICAS DE ALISCIREN | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for aliskiren hemifumarate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1507558 | 12C0033 | France | ⤷ Try a Trial | PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705 |
0678503 | C00678503/04 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011 |
0678503 | SPC/GB07/060 | United Kingdom | ⤷ Try a Trial | 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 |
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 | 2009/010 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/08/491/001-EU/1/08/491/080 20090116; FIRST REGISTRATION NO/DATE: 58935 01 58935 02 58935 03 58935 04 20081028 |
1507558 | 18/2012 | Austria | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - 060 20111122; FIRST REGISTRATION: LI 61678 01-61678 05 20110705 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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