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AMTURNIDE Drug Profile
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Which patents cover Amturnide, and when can generic versions of Amturnide launch?
Amturnide is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and twenty-five patent family members in thirty-one countries.
The generic ingredient in AMTURNIDE is aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide profile page.
US ANDA Litigation and Generic Entry Outlook for Amturnide
Amturnide was eligible for patent challenges on November 5, 2011.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 15, 2021. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for AMTURNIDE
| International Patents: | 125 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | AMTURNIDE at DailyMed |
Generic Entry Opportunity Date for AMTURNIDE
Generic Entry Date for AMTURNIDE*:
Constraining patent/regulatory exclusivity:
NDA:
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.
US Patents and Regulatory Information for AMTURNIDE
Expired US Patents for AMTURNIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-001 | Dec 21, 2010 | Start Trial | Start Trial |
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-002 | Dec 21, 2010 | Start Trial | Start Trial |
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-003 | Dec 21, 2010 | Start Trial | Start Trial |
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-004 | Dec 21, 2010 | Start Trial | Start Trial |
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-005 | Dec 21, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMTURNIDE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 6089278 | Start Trial |
| China | 1153759 | Start Trial |
| Norway | 951441 | Start Trial |
| Cyprus | 2208 | Start Trial |
| Poland | 219032 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AMTURNIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 0678503 | 91373 | Luxembourg | Start Trial | 91373, EXPIRES: 20200407 |
| 1915993 | 2013C/068 | Belgium | Start Trial | PRODUCT NAME: COMBINAISON COMPRENANT L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET L'AMLOPINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/11/686/001 20110415 |
| 1507558 | 113 5008-2012 | Slovakia | Start Trial | PRODUCT NAME: ALISKIREN / AMLODIPIN / HYDROCHLORTIAZID; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - EU/1/11/730/060 20111122; FIRST REGISTRATION: CH 61678 01 - 61678 05 20110705 |
| 1915993 | 122013000093 | Germany | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
