TEKTURNA HCT Drug Patent Profile

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Which patents cover Tekturna Hct, and what generic alternatives are available?

Tekturna Hct is a drug marketed by Noden Pharma and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-five 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.

DrugPatentWatch^® Generic Entry Outlook for Tekturna Hct

Tekturna Hct 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 July 13, 2028. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for TEKTURNA HCT

International Patents:	32
US Patents:	1
Applicants:	1
NDAs:	1
Clinical Trials:	18
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TEKTURNA HCT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TEKTURNA HCT
What excipients (inactive ingredients) are in TEKTURNA HCT?	TEKTURNA HCT excipients list
DailyMed Link:	TEKTURNA HCT at DailyMed

Drug patent expirations by year for TEKTURNA HCT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TEKTURNA HCT

Generic Entry Date for TEKTURNA HCT^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 022107 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.

Recent Clinical Trials for TEKTURNA HCT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wayne State University	Phase 4
University of Alabama at Birmingham	Phase 4
Mayo Clinic	N/A

See all TEKTURNA HCT clinical trials

Paragraph IV (Patent) Challenges for TEKTURNA HCT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TEKTURNA HCT	Tablets	aliskiren hemifumarate; hydrochlorothiazide	150 mg/12.5 mg 150 mg/25 mg 300 mg/12.5 mg 300 mg/25 mg	022107	1	2014-03-07

US Patents and Regulatory Information for TEKTURNA HCT

TEKTURNA HCT is protected by one US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TEKTURNA HCT 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 TEKTURNA HCT

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

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Glossary

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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		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008		DISCN	Yes	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 TEKTURNA HCT

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008	⤷ Sign Up	⤷ Sign Up
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008	⤷ Sign Up	⤷ Sign Up
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008	⤷ Sign Up	⤷ Sign Up
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008	⤷ Sign Up	⤷ Sign Up
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008	⤷ Sign Up	⤷ Sign Up
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for TEKTURNA HCT

When does loss-of-exclusivity occur for TEKTURNA HCT?

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

Argentina

Patent: 1565
Patent: FORMULACIONES GALENICAS DE COMPUESTOS ORGANICOS
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 07263261
Patent: Galenical formulations of aliskiren and hydrochlorothiazide
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 0713338
Patent: formulaÇÕes galÊnicas de compostos orgÂnicos
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 54872
Patent: FORMES GALENIQUES ASSOCIANT ALISKIRENE ET HYDROCHLOROTHIAZIDE (GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE)
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 07001837
Patent: FORMA DE DOSIFICACION ORAL SOLIDA QUE COMPRENDE ALISQUIRENO, HIDROCLOROTIAZIDA Y UN RELLENO HIDROFILICO; PROCESO DE PREPARACION; Y USO EN EL TRATAMIENTO DE ENFERMEDADES TALES COMO HIPERTENSION, INSUFICIENCIA CARDIACA CONGESTIVA, INFARTO DE MIOCARDIO,
Estimated Expiration: ⤷ Sign Up

China

Patent: 1472566
Patent: Galenical formulations of aliskiren and hydrochlorothiazide
Estimated Expiration: ⤷ Sign Up

Ecuador

Patent: 088986
Patent: FORMULACIONES GALÉNICAS DE ALISQUIRENO E HIDROCLOROTIAZIDA
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 34968
Patent: FORMES GALÉNIQUES ASSOCIANT ALISKIRÈNE ET HYDROCHLOROTHIAZIDE (GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE)
Estimated Expiration: ⤷ Sign Up

Patent: 11439
Patent: Formulation galénique contenant de l'aliskiren et l'hydrochlorothiazide (Galenical formulations of aliskiren and hydrochlorothiazide)
Estimated Expiration: ⤷ Sign Up

Patent: 91878
Patent: FORMULATIONS GALÉNIQUES DE COMPOSANTS ORGANIQUES (GALENICAL FORMULATIONS OF ORGANIC COMPOUNDS)
Estimated Expiration: ⤷ Sign Up

Guatemala

Patent: 0800297
Patent: FORMULACIONES GALENICAS DE ALISQUIRENO E HIDROCLOROTIAZIDA
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 5425
Patent: תכשירים גלניקלים של אליסקירן והידרוכלורותיאזיד (Galenical formulations of aliskiren and hydrochlorothiazide)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 62556
Estimated Expiration: ⤷ Sign Up

Patent: 09541239
Estimated Expiration: ⤷ Sign Up

Malaysia

Patent: 6779
Patent: GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 08016533
Patent: FORMULACIONES GALENICAS DE ALISQUIRENO E HIDROCLOROTIAZIDA. (GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE.)
Estimated Expiration: ⤷ Sign Up

Morocco

Patent: 527
Patent: FORMES GALENIQUES ASSOCIANT ALISKIRENE ET HYDROCHLOROTHIAZIDE
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 2937
Patent: Solid oral dosage form of Aliskiren and hydrochlorothiazide which comprise a filler which is a mixture of wheat starch and lactose
Estimated Expiration: ⤷ Sign Up

Norway

Patent: 090262
Estimated Expiration: ⤷ Sign Up

Peru

Patent: 080373
Patent: FORMULACIONES DE ALISQUIRENO E HIDROCLOROTIAZIDA
Estimated Expiration: ⤷ Sign Up

Patent: 120990
Patent: FORMULACIONES DE ALISQUIRENO E HIDROCLOROTIAZIDA
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 91058
Patent: ГАЛЕНОВЫЙ СОСТАВ АЛИСКИРЕНА И ГИДРОХЛОРТИАЗИДА (GALENA COMPOSITION OF ALISKIREN AND HYDROCHLOROTHIAZIDE)
Estimated Expiration: ⤷ Sign Up

Patent: 09101971
Patent: ГАЛЕНОВЫЙ СОСТАВ АЛИСКИРЕНА И ГИДРОХЛОРТИАЗИДА
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 0809773
Patent: Galenical formulations of aliskiren and hydrochlorothiazide
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1442272
Estimated Expiration: ⤷ Sign Up

Patent: 090021353
Patent: GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 04979
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 57137
Estimated Expiration: ⤷ Sign Up

Patent: 0808358
Patent: Galenical formulations of organic compounds
Estimated Expiration: ⤷ Sign Up

Tunisia

Patent: 08528
Patent: GALENICAL FORMULATIONS OF ALISKIREN AND HYDROCHLOROTHIAZIDE
Estimated Expiration: ⤷ Sign Up

United Kingdom

Patent: 12540
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 TEKTURNA HCT around the world.

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Country	Patent Number	Title	Estimated Expiration
China	101264072		⤷ Sign Up
Luxembourg	91564		⤷ Sign Up
Australia	1642095		⤷ Sign Up
United Kingdom	0028151		⤷ Sign Up
South Korea	20110063596		⤷ Sign Up
Greece	3031997		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TEKTURNA HCT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1602370	CA 2009 00010	Denmark	⤷ Sign Up	PRODUCT NAME: ALISKIREN, SOM DETS FRIE BASE ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, SAMT HYDROCHLORTHIAZID ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, HERUNDER ALISKIREN HEMIFUMARAT OG HYDROCHLORTHIAZID; NAT. REG. NO/DATE: EU/1/08/491/001-080 20090116; FIRST REG. NO/DATE: CH 58935 01-04 20081028
1507558	113 5008-2012	Slovakia	⤷ Sign Up	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
1507558	1290018-9	Sweden	⤷ Sign Up	PRODUCT NAME: ALISKIREN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, AMLODIPIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH HYDROKLORTIAZID ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; NAT. REGISTRATIPON NO/DATE: EU/1/11/730 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
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
0678503	C00678503/01	Switzerland	⤷ Sign Up	PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007
2305232	132019000000150	Italy	⤷ Sign Up	PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E IDROCLOROTIAZIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/491, 20090120
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description