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Last Updated: November 21, 2024

TEKAMLO Drug Patent Profile


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DrugPatentWatch® Generic Entry Outlook for Tekamlo

Tekamlo was eligible for patent challenges on March 5, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 21, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TEKAMLO
International Patents:23
US Patents:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 2
Patent Applications: 4
DailyMed Link:TEKAMLO at DailyMed
Drug patent expirations by year for TEKAMLO
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TEKAMLO
Generic Entry Date for TEKAMLO*:
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 TEKAMLO

TEKAMLO is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TEKAMLO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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 TEKAMLO

Galenical formulations of organic compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-001 Aug 26, 2010 DISCN No No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-004 Aug 26, 2010 DISCN No No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-002 Aug 26, 2010 DISCN No No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-003 Aug 26, 2010 DISCN No No ⤷  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

Expired US Patents for TEKAMLO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-001 Aug 26, 2010 ⤷  Sign Up ⤷  Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-004 Aug 26, 2010 ⤷  Sign Up ⤷  Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-003 Aug 26, 2010 ⤷  Sign Up ⤷  Sign Up
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-002 Aug 26, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TEKAMLO

When does loss-of-exclusivity occur for TEKAMLO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 3384
Patent: FORMULACIONES GALENICAS DE COMPUESTOS ORGANICOS QUE COMPRENDEN ALISQUIRENO Y AMLODIPINA, Y METODO DE PREPARACION
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 09292908
Patent: Fixed dose combination in form of a bilayered or monolayered tablet of aliskiren and amlodipine
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0919350
Patent: combinação de dose fixa oral farmacêutica na forma de uma comprimido monocamada, bem como seu uso e seu método de preparação
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 36257
Patent: FORMULATIONS GALENIQUES DE COMPOSES ORGANIQUES (GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 11000594
Patent: Combinacion farmaceutica que comprende: a) 10-45% de alisquireno, b) 0,5-5% de amlodipina, c) 2-15% de un desintegrante, d) 1-60% de un diluyente, e) 0,1-20% de un aglutinante, f) 0,1-5% de un lubricante, g) 0,05-5% de un derrapante y h) opcionalmente un relleno; metodo de preparacion; uso para tratar hipertension.
Estimated Expiration: ⤷  Sign Up

China

Patent: 2159195
Patent: Dual-layer or monolayer form fixed dose combination of aliskiren and amlodipine
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 51711
Patent: COMBINACION DE DOSIS FIJA EN LA FORMA DE UNA TABLETA DE DOS COPAS O DE UNA SOLA CAPA DE ALISQUIRENO Y AMLODIPINA
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 11010999
Patent: COMBINACIÓN DE DOSIS FIJA EN LA FORMA DE UNA TABLETA DE DOS CAPAS O DE UNA SOLA CAPA DE ALISQUIRENO Y AMLODIPINA
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 28564
Patent: FORMULATIONS GALÉNIQUES DE COMPOSÉS ORGANIQUES (FIXED DOSE COMBINATION IN FORM OF A BILAYERED OR MONOLAYERED TABLET OF ALISKIREN AND AMLODIPINE)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 12503020
Estimated Expiration: ⤷  Sign Up

Patent: 15091830
Patent: 有機化合物のガレヌス製剤 (GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 39
Patent: تركيبات جالينية من مركبات عضوية (Galenical Formulations of Organic Compounds)
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 3610
Patent: FIXED DOSE COMBINATION IN FORM OF A BILAYERED OR MONOLAYERED TABLET OF ALISKIREN AND AMLODIPINE
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 11002988
Patent: COMBINACION DE DOSIS FIJA EN LA FORMA DE UNA TABLETA DE DOS CAPAS O DE UNA SOLA CAPA DE ALISQUIRENO Y AMLODIPINA. (FIXED DOSE COMBINATION IN FORM OF A BILAYERED OR MONOLAYERED TABLET OF ALISKIREN AND AMLODIPINE.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 719
Patent: تركيبات خاصة بصناعة الأدوية من مركبات عضوية
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 110293
Patent: COMBINACION DE DOSIS FIJA EN LA FORMA DE UNA TABLETA DE UNA SOLA CAPA QUE COMPRENDE ALISQUIRENO Y AMLODIPINA
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 11115712
Patent: КОМБИНАЦИИ С ФИКСИРОВАННОЙ ДОЗОЙ АЛИСКИРЕНА И АМЛОДИПИНА В ФОРМЕ ДВУХСЛОЙНЫХ ИЛИ ОДНОСЛОЙНЫХ ТАБЛЕТОК
Estimated Expiration: ⤷  Sign Up

Patent: 14140552
Patent: КОМБИНАЦИИ С ФИКСИРОВАННОЙ ДОЗОЙ АЛИСКИРЕНА И АМЛОДИПИНА В ФОРМЕ ДВУХСЛОЙНЫХ ИЛИ ОДНОСЛОЙНЫХ ТАБЛЕТОК
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1101644
Patent: FIXED DOSE COMBINATION IN FORM OF A BILAYERED OR MONOLAYERED TABLET OF ALISKIREN AND AMLODIPINE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 110060942
Patent: FIXED DOSE COMBINATION IN FORM OF BILAYERED OR MONOLAYERED TABLET OF ALISKIREN AND AMLODIPINE
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 1016217
Patent: Galenical formulations of organic compounds
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 11000100
Patent: GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TEKAMLO around the world.

Country Patent Number Title Estimated Expiration
South Africa 9503052 ⤷  Sign Up
Israel 113402 ⤷  Sign Up
South Korea 20110060942 FIXED DOSE COMBINATION IN FORM OF BILAYERED OR MONOLAYERED TABLET OF ALISKIREN AND AMLODIPINE ⤷  Sign Up
Israel 113384 ⤷  Sign Up
Netherlands 300296 ⤷  Sign Up
Canada 2147056 AMIDES D'ACIDE DELTA-AMINO-GAMMA-HYDROXY-OMEGA-ARYLALCANOIQUE (NOVEL DELTA-AMINO-GAMMA-HYDROXY-OMEGA-ARYL-ALKANOIC ACID AMIDES) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TEKAMLO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1915993 13C0063 France ⤷  Sign Up PRODUCT NAME: COMBINAISON COMPRENANT DE L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET DE L'ALMODIPINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/686/001 20110414
2305232 122019000098 Germany ⤷  Sign Up PRODUCT NAME: ALISKIREN HEMIFUMARAT UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116
1915993 132013902215595 Italy ⤷  Sign Up PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E AMLODIPINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILAMLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/686/001-056, 20110414
1915993 122013000093 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
1507558 132012902049405 Italy ⤷  Sign Up PRODUCT NAME: ALISKIREN, AMLODIPINA, IDROCLOROTIAZIDE(RASITRIO); AUTHORISATION NUMBER(S) AND DATE(S): 61678/01/02/03/04/05, 20110705;EU/1/11/730/001-060, 20111122
1915993 C300625 Netherlands ⤷  Sign Up PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
>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.