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 freedom to operate?
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
| 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 | 022107-001 | Jan 18, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-003 | Jan 18, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-004 | Jan 18, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-002 | Jan 18, 2008 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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
International Patents for aliskiren hemifumarate; hydrochlorothiazide
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Tunisia | SN08528 | GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE | ⤷ Try a Trial |
| South Korea | 20090021353 | GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2007147596 | ⤷ Try a Trial | |
| United Kingdom | 0612540 | ⤷ Try a Trial | |
| Ecuador | SP088986 | FORMULACIONES GALÉNICAS DE ALISQUIRENO E HIDROCLOROTIAZIDA | ⤷ Try a Trial |
| Spain | 2704979 | ⤷ Try a Trial | |
| Peru | 20120990 | FORMULACIONES DE ALISQUIRENO E HIDROCLOROTIAZIDA | ⤷ 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 | 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 | C300528 | Netherlands | ⤷ Try a Trial | 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 |
| 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 |
| 2305232 | 122019000098 | Germany | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN HEMIFUMARAT UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116 |
| 2305232 | 301005 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/08/491 20090120 |
| 0678503 | 07C0055 | France | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822 |
| 1915993 | 92315 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
