TEKTURNA HCT Drug Patent Profile

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

Summary for TEKTURNA HCT

International Patents:	32
US Patents:	1
Applicants:	1
NDAs:	1
Clinical Trials:	18
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

See drug prices for TEKTURNA HCT

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

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.

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

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

Expired US Patents for TEKTURNA HCT

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
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008

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

Australia

Brazil

Canada

Chile

China

Ecuador

European Patent Office

Guatemala

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Russian Federation

South Africa

South Korea

Spain

Taiwan

Tunisia

United Kingdom

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.

Country	Patent Number	Title	Estimated Expiration
Slovakia	287881
Czech Republic	305341	Farmaceutická kompozice, souprava obsahující účinné látky této kompozice a použití kombinace účinných látek této kompozice (Pharmaceutical composition, kit comprising active substances of the composition and the use of combination of active substances of the composition)
Japan	6603757
Cyprus	2208	Delta-amino-gamma-hydroxy-omega-aryl alkanoic acidamides with enzyme especially renin inhibiting ac tivities
European Patent Office	1915993	Mélange synergique comprenant un inhibiteur de la rénine pour le traitement des maladies cardiovasculaires (Synergistic combinations comprising a renin inhibitor for cardiovascular diseases)
Peru	20080373	FORMULACIONES DE ALISQUIRENO E HIDROCLOROTIAZIDA
Guatemala	200800297	FORMULACIONES GALENICAS DE ALISQUIRENO E HIDROCLOROTIAZIDA

Supplementary Protection Certificates for TEKTURNA HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0678503	91373	Luxembourg		91373, EXPIRES: 20200407
0678503	CA 2007 00049	Denmark
1602370	09C0020	France		PRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028
0678503	SPC/GB07/060	United Kingdom		PRODUCT NAME: ALISKIREN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/405/001 20070822; UK EU/1/04/405/002 20070822; UK EU/1/04/405/003 20070822; UK EU/1/04/405/004 20070822; UK EU/1/04/405/005 20070822; UK EU/1/04/405/006 20070822; UK EU/1/04/405/007 20070822; UK EU/1/04/405/008 20070822; UK EU/1/04/405/009 20070822; UK EU/1/04/405/010 20070822; UK EU/1/04/405/011 20070822; UK EU/1/04/405/012 20070822; UK EU/1/04/405/013 20070822; UK EU/1/04/405/014 20070822; UK EU/1/04/405/015 20070822; UK EU/1/04/405/016 20070822; UK EU/1/04/405/017 20070822; UK EU/1/04/405/018 20070822; UK EU/1/04/405/019 20070822; UK EU/1/04/405/020 20070822
1915993	2013/058	Ireland		2013/058 DECLARED INVALID WITH ARTICLE 15 1C OF REGULATION EC NO. 469/2009
2305232	301005	Netherlands		PRODUCT NAME: ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/08/491 20090120
0678503	C300386	Netherlands		PRODUCT NAME: COMBINATIE OMVATTENDE ALISKIREN, ALS VRIJE BASE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; NATL. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: CH 58935 01-04 20081028

TEKTURNA HCT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TEKTURNA HCT

Introduction to TEKTURNA HCT

TEKTURNA HCT, also known as Rasilez HCT outside the United States, is a prescription medication used for the treatment of hypertension. It combines aliskiren, a direct renin inhibitor, with hydrochlorothiazide, a diuretic. This combination is designed to provide a more comprehensive approach to blood pressure management.

Market Overview

The renin-inhibitors market, which includes TEKTURNA HCT, is expected to grow at a CAGR of 6.7% during the forecast period from 2023 to 2032. This growth is driven by increasing demand for effective hypertension treatments and the expansion of production facilities in developing countries[1].

Product Segmentation

TEKTURNA HCT is segmented by product type, including 150mg/tablet and 300mg/tablet formulations, among others. The market is also segmented geographically, with key regions including North America, Latin America, Europe, Asia Pacific, Middle East, and Africa[1].

Competitive Environment

The competitive landscape of the renin-inhibitors market is characterized by strategic moves such as new product development, partnerships, and the expansion of distribution networks. Companies in this market focus on innovation and collaborations to enhance product quality and output. For instance, PDL BioPharma has invested in acquiring and managing assets related to TEKTURNA HCT, indicating a strong competitive strategy[1][4].

Financial Performance

Revenue Highlights

In the second quarter of 2019, PDL BioPharma reported product revenues of $10.4 million from the sales of TEKTURNA and TEKTURNA HCT in the U.S. and Rasilez and Rasilez HCT in the rest of the world. This includes revenue from the authorized generic form of TEKTURNA in the U.S.[5].

Historically, in the second quarter of 2018, product revenues from TEKTURNA and TEKTURNA HCT were $25.9 million, contributing significantly to PDL BioPharma's total product revenues of $31.8 million[2].

Market Share

As of the second quarter of 2019, branded TEKTURNA and its authorized generic maintained a 74% U.S. market share, indicating strong market presence and customer loyalty[5].

Challenges and Opportunities

Competition from Established Drugs

One of the significant challenges faced by TEKTURNA HCT is competition from well-established hypertension drugs. For example, Novartis' Diovan (valsartan), an angiotensin receptor antagonist, has been highly successful and makes it challenging for TEKTURNA to gain significant market share. Despite being hailed as a novel approach to hypertension, TEKTURNA's sales have been modest compared to Diovan[3].

Life Cycle Management

To mitigate this, Novartis and subsequent owners like PDL BioPharma have employed life cycle management strategies. This includes marketing TEKTURNA in combination with other drugs, such as calcium channel blockers and diuretics, to create combination products like Exforge and Exforge HCT[3].

Strategic Transactions and Investments

PDL BioPharma has made strategic investments to acquire and manage the rights to TEKTURNA and TEKTURNA HCT. For instance, the company closed an equity investment transaction with Noden Pharma to acquire these products, which were previously marketed by Novartis. This move is part of PDL BioPharma's strategy to shift from passive investments to actively managed assets[4].

Operational Expenses and Profitability

The operational expenses for PDL BioPharma, including those related to TEKTURNA HCT, have been significant. In the second quarter of 2019, total operating expenses were $27.4 million, with notable components including general and administrative expenses, sales and marketing, and research and development costs[5].

Despite these expenses, PDL BioPharma has reported positive cash flow from its operating companies, including Noden, which manages TEKTURNA HCT. This cash flow is expected to exceed operational needs, providing additional funds for future investments[5].

Non-Operating Income and Expenses

Non-operating income and expenses have also played a crucial role in the financial trajectory of TEKTURNA HCT. For example, in the second quarter of 2019, PDL BioPharma reported a non-cash writedown of the fair market value of certain royalty assets, which impacted their net income. However, interest and other income have helped offset some of these expenses[5].

Regional Performance

The performance of TEKTURNA HCT varies by region. In the U.S., the drug has maintained a strong market share, while in other regions, it is marketed under the name Rasilez HCT. The global distribution and marketing efforts by companies like Novartis and PDL BioPharma have been crucial in maintaining its presence in various markets[1][4].

Future Outlook

The future outlook for TEKTURNA HCT is positive, driven by the growing demand for hypertension treatments and the strategic investments made by companies like PDL BioPharma. The expected CAGR of 6.7% for the renin-inhibitors market indicates a promising trajectory for this drug[1].

Key Takeaways

• Market Growth: The renin-inhibitors market, including TEKTURNA HCT, is expected to grow at a CAGR of 6.7% from 2023 to 2032.
• Competitive Strategy: Companies are focusing on innovation, partnerships, and distribution network expansion.
• Financial Performance: TEKTURNA HCT has contributed significantly to PDL BioPharma's product revenues.
• Market Share: The drug maintains a strong market share in the U.S.
• Challenges: Competition from established drugs like Diovan and the need for life cycle management strategies.
• Future Outlook: Positive, driven by growing demand and strategic investments.

FAQs

What is TEKTURNA HCT used for?

TEKTURNA HCT is used for the treatment of hypertension. It combines aliskiren, a direct renin inhibitor, with hydrochlorothiazide, a diuretic.

Who are the key players in the renin-inhibitors market?

Key players include Novartis, which initially developed and marketed TEKTURNA HCT, and PDL BioPharma, which has acquired the rights to the drug.

What is the expected market growth for renin-inhibitors?

The renin-inhibitors market is expected to grow at a CAGR of 6.7% from 2023 to 2032.

What are the main challenges faced by TEKTURNA HCT in the market?

The main challenges include competition from well-established hypertension drugs like Diovan and the need for effective life cycle management strategies.

How has PDL BioPharma's acquisition of TEKTURNA HCT impacted its financial performance?

The acquisition has contributed significantly to PDL BioPharma's product revenues and has been part of the company's strategy to shift from passive investments to actively managed assets.

Cited Sources

1. OpenPR: Renin-Inhibitors Market is Segmented By Drug (TEKTURNA (aliskiren), TEKTURNA HCT (aliskiren/hydrochlorothiazide))...
2. BioSpace: PDL BioPharma Reports Second Quarter 2018 Financial Results
3. Pharmaceutical Executive: The Book on Daniel
4. PDL BioPharma: PDL BioPharma Closes Equity Investment Transaction in Noden Pharma for the Acquisition of Tekturna® (aliskiren) and Tekturna HCT® (aliskiren and hydrochlorothiazide)
5. PR Newswire: PDL BioPharma Reports 2019 Second Quarter Financial Results