ALISKIREN HEMIFUMARATE - Generic Drug Details
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What are the generic 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, Endo Operations, 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: | 215 |
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 | 200045-002 | Dec 21, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | 022107-004 | Jan 18, 2008 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Noden Pharma | TEKTURNA | aliskiren hemifumarate | TABLET;ORAL | 021985-001 | Mar 5, 2007 | AB | RX | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Noden Pharma | TEKTURNA | aliskiren hemifumarate | TABLET;ORAL | 021985-001 | Mar 5, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Noden Pharma | TEKTURNA | aliskiren hemifumarate | TABLET;ORAL | 021985-002 | Mar 5, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ALISKIREN HEMIFUMARATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Russian Federation | 2384328 | ГАЛЕНОВЫ СОСТАВЫ ОРГАНИЧЕСКИХ СОЕДИНЕНИЙ (HALENIC COMPOSITIONS OF ORGANIC COMPOUNDS) | ⤷ Sign Up |
South Africa | 200606220 | GALENIC FORMULATIONS OF ORGANIC COMPOUNDS | ⤷ Sign Up |
Norway | 20064670 | ⤷ Sign Up | |
Malaysia | 148773 | GALENIC FORMULATIONS OF ORGANIC COMPOUNDS | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ALISKIREN HEMIFUMARATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1915993 | 1390055-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: KOMBINATION INNEFATTANDE ALISKIREN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH AMLODIPIN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/11/686/001 20110414 |
2305232 | 132019000000150 | Italy | ⤷ Sign Up | 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 |
1602370 | 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; NAT. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: LI 58935 20081028 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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