AMTURNIDE Drug Patent 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 is one patent protecting this drug.
This drug has thirty-two patent family members in twenty-four 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.
DrugPatentWatch® 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 May 16, 2023. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for AMTURNIDE
| International Patents: | 32 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | AMTURNIDE at DailyMed |
DrugPatentWatch® Estimated 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.
Anatomical Therapeutic Chemical (ATC) Classes for AMTURNIDE
US Patents and Regulatory Information for AMTURNIDE
AMTURNIDE is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AMTURNIDE is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting AMTURNIDE
Pharmaceutical composition comprising a renin inhibitor, a calcium channel blocker and a diuretic
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
| 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 | 200045-001 | Dec 21, 2010 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-004 | Dec 21, 2010 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-002 | Dec 21, 2010 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-003 | Dec 21, 2010 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >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 AMTURNIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-004 | Dec 21, 2010 | See Plans and Pricing | See Plans and Pricing |
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-002 | Dec 21, 2010 | See Plans and Pricing | See Plans and Pricing |
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-001 | Dec 21, 2010 | See Plans and Pricing | See Plans and Pricing |
| Novartis | AMTURNIDE | aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide | TABLET;ORAL | 200045-003 | Dec 21, 2010 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMTURNIDE
See the table below for patents covering AMTURNIDE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 0678503 | See Plans and Pricing | |
| Hungary | 1400409 | See Plans and Pricing | |
| New Zealand | 270936 | DELTA-AMINO GAMMA-HYDROXY OMEGA-ARYL ALKANOIC ACID AMIDES, PHARMACEUTICAL COMPOSITIONS THEREOF, AND INTERMEDIATES | See Plans and Pricing |
| Greece | 3031997 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMTURNIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0678503 | C00678503/02 | Switzerland | See Plans and Pricing | PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008 |
| 1507558 | C20120009 00055 | Estonia | See Plans and Pricing | PRODUCT NAME: RASITRIO - ALISKIREEN/AMLODIPIIN/HUEDROKLOROTIASIID;REG NO/DATE: C(2011)8695 FINAL 22.11.2011 |
| 0678503 | C300499 | Netherlands | See Plans and Pricing | PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114 |
| 1507558 | CA 2012 00018 | Denmark | See Plans and Pricing | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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