Aliskiren hemifumarate; hydrochlorothiazide - Generic Drug Details
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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
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 HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-004 | Jan 18, 2008 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-002 | Jan 18, 2008 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-003 | Jan 18, 2008 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-001 | Jan 18, 2008 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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; hydrochlorothiazide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-004 | Jan 18, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-001 | Jan 18, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-002 | Jan 18, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-003 | Jan 18, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-002 | Jan 18, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for aliskiren hemifumarate; hydrochlorothiazide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Russian Federation | 2009101971 | ГАЛЕНОВЫЙ СОСТАВ АЛИСКИРЕНА И ГИДРОХЛОРТИАЗИДА | ⤷ Sign Up |
South Korea | 20090021353 | GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE | ⤷ Sign Up |
Brazil | PI0713338 | formulaÇÕes galÊnicas de compostos orgÂnicos | ⤷ Sign Up |
Tunisia | SN08528 | GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE | ⤷ Sign Up |
Taiwan | 200808358 | Galenical formulations of organic compounds | ⤷ Sign Up |
>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 | 300625 | Netherlands | ⤷ Sign Up | 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 |
1507558 | C300528 | Netherlands | ⤷ Sign Up | 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 |
1602370 | SPC/GB09/024 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4 |
1602370 | SZ 11/2009 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON |
1915993 | 2013C/068 | Belgium | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |