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Last Updated: May 27, 2022

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

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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
Drug patent expirations by year for AMTURNIDE
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.

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

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

Make Better Decisions: Try a trial or see plans & pricing

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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.