DrugPatentWatch Database Preview
TEKTURNA HCT Drug Profile
When do Tekturna Hct patents expire, and when can generic versions of Tekturna Hct launch?
This drug has one hundred and eighty-one patent family members in forty-one countries.
The generic ingredient in TEKTURNA HCT is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.
Summary for TEKTURNA HCT
| International Patents: | 181 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 17 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | TEKTURNA HCT at DailyMed |
US Patents and Regulatory Information for TEKTURNA HCT
| 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 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-003 | Jan 18, 2008 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-002 | Jan 18, 2008 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Noden Pharma | TEKTURNA HCT | aliskiren hemifumarate; hydrochlorothiazide | TABLET;ORAL | 022107-004 | Jan 18, 2008 | RX | Yes | Yes | ➤ 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 |
Paragraph IV (Patent) Challenges for TEKTURNA HCT
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, 300 mg/25 mg | ➤ Subscribe | 2014-03-07 |
Non-Orange Book US Patents for TEKTURNA HCT
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 9,023,894 | Synergistic combinations comprising a renin inhibitor for cardiovascular diseases | ➤ Sign Up |
| 8,168,616 | Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension | ➤ Sign Up |
| 5,646,143 | .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides | ➤ Sign Up |
| 5,654,445 | .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for TEKTURNA HCT
| Country | Document Number | Estimated Expiration |
|---|---|---|
| South Korea | 20080096715 | ➤ Sign Up |
| Denmark | 1602370 | ➤ Sign Up |
| Poland | 400914 | ➤ Sign Up |
| South Korea | 20110063596 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for TEKTURNA HCT
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 12/018 | Ireland | ➤ Sign Up | PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705 |
| 2009 00009 | Denmark | ➤ Sign Up | |
| 2013000093 | Germany | ➤ Sign Up | PRODUCT NAME: KOMBINATION UMFASSEND ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/686/001 - 056 20110414 |
| 2012000031 | Germany | ➤ Sign Up | PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 1), AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 2) UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 3); NAT. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: SCHWEIZ 61678 01 - 05 20110705 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
