Aliskiren hemifumarate; hydrochlorothiazide - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for aliskiren hemifumarate; hydrochlorothiazide and what is the scope of patent protection?
Aliskiren hemifumarate; hydrochlorothiazide
is the generic ingredient in one branded drug marketed by Noden Pharma and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Aliskiren hemifumarate; hydrochlorothiazide has thirty-two patent family members in twenty-five countries.
Summary for aliskiren hemifumarate; hydrochlorothiazide
International Patents: | 32 |
US Patents: | 1 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for aliskiren hemifumarate; hydrochlorothiazide |
DailyMed Link: | aliskiren hemifumarate; hydrochlorothiazide at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for aliskiren hemifumarate; hydrochlorothiazide
Generic Entry Date for aliskiren hemifumarate; hydrochlorothiazide*:
Constraining patent/regulatory exclusivity:
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; hydrochlorothiazide
Paragraph IV (Patent) Challenges for ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TEKTURNA HCT | Tablets | aliskiren hemifumarate; hydrochlorothiazide | 150 mg/12.5 mg 150 mg/25 mg 300 mg/12.5 mg 300 mg/25 mg | 022107 | 1 | 2014-03-07 |
US Patents and Regulatory Information for aliskiren hemifumarate; hydrochlorothiazide
Expired US Patents for aliskiren hemifumarate; hydrochlorothiazide
International Patents for aliskiren hemifumarate; hydrochlorothiazide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 200809773 | Galenical formulations of aliskiren and hydrochlorothiazide | ⤷ Try a Trial |
New Zealand | 572937 | Solid oral dosage form of Aliskiren and hydrochlorothiazide which comprise a filler which is a mixture of wheat starch and lactose | ⤷ Try a Trial |
South Korea | 101442272 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2007147596 | ⤷ Try a Trial | |
Japan | 5362556 | ⤷ Try a Trial | |
Argentina | 061565 | FORMULACIONES GALENICAS DE COMPUESTOS ORGANICOS | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for aliskiren hemifumarate; hydrochlorothiazide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1602370 | 132009901728448 | Italy | ⤷ Try a Trial | PRODUCT NAME: (ALISKIREN EMIFUMARATO/IDROCLOROTIAZIDE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/08/491/001 A EU/1/08/491/080, 20090116 |
1915993 | 13C0063 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON COMPRENANT DE L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET DE L'ALMODIPINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/686/001 20110414 |
1602370 | 09C0020 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON COMRENANT LALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET LHYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028 |
1507558 | C01507558/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN + AMLODIPIN + HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: SWISSMEDIC 61678 05.07.2011 |
2305232 | C201930070 | Spain | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN HEMIFUMARATO + HIDROCLOROTIAZIDA; NATIONAL AUTHORISATION NUMBER: EU/1/08/491/001-080; DATE OF AUTHORISATION: 20090116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/08/491/001-080; DATE OF FIRST AUTHORISATION IN EEA: 20090116 |
0678503 | C300296 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN OF EEN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |