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 | 022107-001 | 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 | 022107-002 | 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 | |||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-002 | Jan 18, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-002 | Jan 18, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 | ⤷ Try a Trial |
| Argentina | 061565 | FORMULACIONES GALENICAS DE COMPUESTOS ORGANICOS | ⤷ Try a Trial |
| European Patent Office | 3391878 | FORMULATIONS GALÉNIQUES DE COMPOSANTS ORGANIQUES (GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS) | ⤷ 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 | 300625 | Netherlands | ⤷ Try a Trial | 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 |
| 1602370 | CA 2009 00010 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN, SOM DETS FRIE BASE ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, SAMT HYDROCHLORTHIAZID ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, HERUNDER ALISKIREN HEMIFUMARAT OG HYDROCHLORTHIAZID; NAT. REG. NO/DATE: EU/1/08/491/001-080 20090116; FIRST REG. NO/DATE: CH 58935 01-04 20081028 |
| 0678503 | C00678503/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
