ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - Generic Drug Details
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What are the generic 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.
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 |
---|---|---|---|
European Patent Office | 2311439 | Formulation galénique contenant de l'aliskiren et l'hydrochlorothiazide (Galenical formulations of aliskiren and hydrochlorothiazide) | ⤷ Try a Trial |
Tunisia | SN08528 | GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE | ⤷ Try a Trial |
Malaysia | 146779 | GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE | ⤷ Try a Trial |
Taiwan | 200808358 | Galenical formulations of organic compounds | ⤷ Try a Trial |
Mexico | 2008016533 | FORMULACIONES GALENICAS DE ALISQUIRENO E HIDROCLOROTIAZIDA. (GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE.) | ⤷ Try a Trial |
Norway | 20090262 | ⤷ 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 |
---|---|---|---|---|
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 |
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 | SZ 11/2009 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON |
1507558 | 1290018-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, AMLODIPIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH HYDROKLORTIAZID ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; NAT. REGISTRATIPON NO/DATE: EU/1/11/730 20111122; FIRST REGISTRATION: CH 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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |