ALISKIREN HEMIFUMARATE - Generic Drug Details
✉ Email this page to a colleague
What are the generic 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 |
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 |
---|---|---|---|
Malaysia | 144477 | GALENIC FORMULATIONS OF ORGANIC COMPOUNDS | ⤷ Try a Trial |
New Zealand | 548823 | Galenic formulations of organic compounds (oral dosage of aliskiren) | ⤷ Try a Trial |
Singapore | 153830 | GALENIC FORMULATIONS OF ORGANIC COMPOUNDS | ⤷ Try a Trial |
Mexico | 347617 | FORMULACIONES GALENICAS DE COMPUESTOS ORGANICOS. (GALENIC FORMULATIONS OF ORGANIC COMPOUNDS.) | ⤷ Try a Trial |
South Korea | 101353736 | ⤷ Try a Trial | |
Japan | 2012211152 | GALENIC FORMULATION OF ORGANIC COMPOUND | ⤷ Try a Trial |
South Korea | 20130028803 | GALENIC FORMULATIONS OF ORGANIC COMPOUNDS | ⤷ 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 | 122012000031 | Germany | ⤷ Try a Trial | 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 |
1915993 | 2013C/068 | Belgium | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON COMPRENANT L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET L'AMLOPINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/11/686/001 20110415 |
1915993 | 1390055-0 | Sweden | ⤷ Try a Trial | 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 |
1507558 | CR 2012 00018 | Denmark | ⤷ Try a Trial | 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 |
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 | C300296 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN OF EEN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822 |
0678503 | C00678503/02 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.