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 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.
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
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 |
Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-001 | 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 |
---|---|---|---|
Mexico | 2008016533 | FORMULACIONES GALENICAS DE ALISQUIRENO E HIDROCLOROTIAZIDA. (GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE.) | ⤷ Try a Trial |
Japan | 5362556 | ⤷ Try a Trial | |
Spain | 2704979 | ⤷ Try a Trial | |
Canada | 2654872 | FORMES GALENIQUES ASSOCIANT ALISKIRENE ET HYDROCHLOROTHIAZIDE (GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE) | ⤷ 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 |
---|---|---|---|---|
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 |
0678503 | C00678503/04 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011 |
0678503 | SPC/GB07/060 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/405/001 20070822; UK EU/1/04/405/002 20070822; UK EU/1/04/405/003 20070822; UK EU/1/04/405/004 20070822; UK EU/1/04/405/005 20070822; UK EU/1/04/405/006 20070822; UK EU/1/04/405/007 20070822; UK EU/1/04/405/008 20070822; UK EU/1/04/405/009 20070822; UK EU/1/04/405/010 20070822; UK EU/1/04/405/011 20070822; UK EU/1/04/405/012 20070822; UK EU/1/04/405/013 20070822; UK EU/1/04/405/014 20070822; UK EU/1/04/405/015 20070822; UK EU/1/04/405/016 20070822; UK EU/1/04/405/017 20070822; UK EU/1/04/405/018 20070822; UK EU/1/04/405/019 20070822; UK EU/1/04/405/020 20070822 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |