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TEKTURNA Drug Profile
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» See Plans and PricingWhich patents cover Tekturna, and when can generic versions of Tekturna launch?
Tekturna is a drug marketed by Noden Pharma and is included in three NDAs. There are three patents protecting this drug and two Paragraph IV challenges.
This drug has forty-one patent family members in twenty-three countries.
The generic ingredient in TEKTURNA is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.
US ANDA Litigation and Generic Entry Outlook for Tekturna
Tekturna was eligible for patent challenges on March 5, 2011.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for TEKTURNA
| International Patents: | 41 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 3 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 102 |
| Clinical Trials: | 17 |
| Patent Applications: | 825 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TEKTURNA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TEKTURNA |
| DailyMed Link: | TEKTURNA at DailyMed |
Recent Clinical Trials for TEKTURNA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Wayne State University | Phase 4 |
| University of Alabama at Birmingham | Phase 4 |
| Mayo Clinic | N/A |
Pharmacology for TEKTURNA
| Drug Class | Renin Inhibitor |
| Mechanism of Action | Renin Inhibitors |
Paragraph IV (Patent) Challenges for TEKTURNA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TEKTURNA | TABLET;ORAL | aliskiren hemifumarate | 021985 | 2014-01-27 |
US Patents and Regulatory Information for TEKTURNA
| 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 | aliskiren hemifumarate | CAPSULE, PELLET;ORAL | 210709-001 | Nov 14, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-002 | Jan 18, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Noden Pharma | TEKTURNA | aliskiren hemifumarate | TABLET;ORAL | 021985-002 | Mar 5, 2007 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-004 | Jan 18, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-002 | Jan 18, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Start 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 TEKTURNA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Noden Pharma | TEKTURNA | aliskiren hemifumarate | TABLET;ORAL | 021985-001 | Mar 5, 2007 | Start Trial | Start Trial |
| Noden Pharma | TEKTURNA | aliskiren hemifumarate | TABLET;ORAL | 021985-002 | Mar 5, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TEKTURNA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 0678503 | Start Trial |
| Singapore | 153830 | Start Trial |
| Australia | 1642095 | Start Trial |
| Taiwan | 402582 | Start Trial |
| China | 1117960 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TEKTURNA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0678503 | CA 2011 00027 | Denmark | Start Trial | |
| 1602370 | C300385 | Netherlands | Start Trial | PRODUCT NAME: ALISKIREN, DESGEWENST IN DE VORM; REGISTRATION NO/DATE: 58935 01-04 20081028 |
| 1915993 | 1390055-0 | Sweden | Start Trial | 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 |
| 1602370 | 132009901728448 | Italy | Start Trial | PRODUCT NAME: (ALISKIREN EMIFUMARATO/IDROCLOROTIAZIDE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/08/491/001 A EU/1/08/491/080, 20090116 |
| 1602370 | SZ 11/2009 | Austria | Start Trial | PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
