Aliskiren hemifumarate - Generic Drug Details
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What are the generic drug sources for aliskiren hemifumarate and what is the scope of patent protection?
Aliskiren hemifumarate
is the generic ingredient in six branded drugs marketed by Noden Pharma, Anchen Pharms, and Novartis, and is included in seven NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Aliskiren hemifumarate has forty patent family members in twenty-two countries.
There are four drug master file entries for aliskiren hemifumarate. Four suppliers are listed for this compound.
Summary for aliskiren hemifumarate
International Patents: | 40 |
US Patents: | 4 |
Tradenames: | 6 |
Applicants: | 3 |
NDAs: | 7 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 63 |
Patent Applications: | 239 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for aliskiren hemifumarate |
What excipients (inactive ingredients) are in aliskiren hemifumarate? | aliskiren hemifumarate excipients list |
DailyMed Link: | aliskiren hemifumarate at DailyMed |
Pharmacology for aliskiren hemifumarate
Drug Class | Renin Inhibitor |
Mechanism of Action | Renin Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for aliskiren hemifumarate
Paragraph IV (Patent) Challenges for ALISKIREN HEMIFUMARATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TEKTURNA | Tablets | aliskiren hemifumarate | 150 mg and 300 mg | 021985 | 1 | 2014-01-27 |
US Patents and Regulatory Information for aliskiren hemifumarate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-003 | Dec 21, 2010 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
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 | |||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Noden Pharma | TEKTURNA | aliskiren hemifumarate | TABLET;ORAL | 021985-001 | Mar 5, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Noden Pharma | TEKTURNA | aliskiren hemifumarate | TABLET;ORAL | 021985-002 | Mar 5, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for aliskiren hemifumarate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | I406656 | ⤷ Try a Trial | |
Ecuador | SP066807 | FORMULACIONES GALÉNICAS DE COMPUESTOS ORGÁNICOS | ⤷ Try a Trial |
South Korea | 101353736 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for aliskiren hemifumarate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0678503 | C00678503/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007 |
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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