TEKTURNA Drug Patent Profile

Which patents cover Tekturna, and when can generic versions of Tekturna launch?

Tekturna is a drug marketed by Noden Pharma and is included in three NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in twenty-two countries.

The generic ingredient in TEKTURNA 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

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

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

International Patents:	40
US Patents:	1
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	18
Patent Applications:	106
Drug Prices:	Drug price information for TEKTURNA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TEKTURNA
What excipients (inactive ingredients) are in TEKTURNA?	TEKTURNA excipients list
DailyMed Link:	TEKTURNA at DailyMed

See drug prices for TEKTURNA

Recent Clinical Trials for TEKTURNA

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 clinical trials

Pharmacology for TEKTURNA

Drug Class	Renin Inhibitor
Mechanism of Action	Renin Inhibitors

Paragraph IV (Patent) Challenges for TEKTURNA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TEKTURNA	Tablets	aliskiren hemifumarate	150 mg and 300 mg	021985	1	2014-01-27

US Patents and Regulatory Information for TEKTURNA

TEKTURNA is protected by one US patents.

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	aliskiren hemifumarate	CAPSULE, PELLET;ORAL	210709-001	Nov 14, 2017		DISCN	Yes	No
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	022107-001	Jan 18, 2008		DISCN	Yes	No			Y
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007	AB	RX	Yes	No					Y
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007	AB	RX	Yes	Yes					Y

Expired US Patents for TEKTURNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007

International Patents for TEKTURNA

See the table below for patents covering TEKTURNA around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	226860	NEW DELTA-AMINO-GAMMA-HYDROXY-OMEGA-ARYL-ALKANE-CARBOXYLIC-ACID-AMIDES, PROCESS FOR PREPARING THEM AND PHARMACEUTICAL COMPNS. CONTG. THEM
Finland	951773
Denmark	0678503
China	1153759
New Zealand	270939	SUBSTITUTED TETRAHYDROFURAN-2-ONES AND OXAZOLIDIN-2-ONES AS INTERMEDIATES FOR THE PREPARATION OF PHARMACEUTICALLY ACTIVE AGENTS

Supplementary Protection Certificates for TEKTURNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	300625	Netherlands		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
1507558	C01507558/01	Switzerland		PRODUCT NAME: ALISKIREN + AMLODIPIN + HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: SWISSMEDIC 61678 05.07.2011
0678503	CA 2011 00027	Denmark
0678503	CA 2007 00049	Denmark
1602370	SPC/GB09/024	United Kingdom		PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4

Market Dynamics and Financial Trajectory for the Drug: Tekturna

Introduction

Tekturna, also known as Rasilez in Europe, is a first-in-class drug developed by Novartis that directly inhibits renin, a key enzyme in the renin-angiotensin system (RAS) which regulates blood pressure. Here, we delve into the market dynamics and financial trajectory of this drug.

Approval and Initial Market Reception

Tekturna was approved by the FDA in 2007 for the treatment of high blood pressure. Initially, industry analysts predicted peak sales of over $1 billion annually, given the vast market of hypertensive patients worldwide[4].

Mechanism of Action and Clinical Trials

Tekturna works by inhibiting renin, which is at the top of the RAS cascade. However, clinical trials revealed that the drug's efficacy was limited due to the body's compensatory increase in renin secretion in response to the drug. This led to results that were no better than those of existing classes of blood pressure medications such as converting enzyme inhibitors (CEI), angiotensin receptor blockers (ARB), or diuretics[4].

Market Performance and Sales

Despite its innovative mechanism, Tekturna's sales were significantly lower than expected. In 2010, Tekturna generated only $290 million in sales, a fraction compared to Novartis' flagship blood pressure treatment, Diovan (valsartan), which reached $6 billion in sales the same year[1].

Impact of Patent Expiration

Novartis was pushing to expand the indications for Tekturna before the patent expiration of Diovan, which was anticipated in 2011 and 2012 for Europe and the US, respectively. However, the lack of clinical superiority and the impending generic competition for Diovan further complicated Tekturna's market position[1].

Financial Performance

The financial performance of Tekturna was modest at best. In 2019, PDL BioPharma, which acquired the rights to Tekturna from Novartis, reported that the branded Tekturna and its authorized generic maintained a 74% U.S. market share. However, the revenue from Tekturna was $10.4 million, a small fraction of PDL BioPharma's overall revenue[2].

Market Challenges

Several factors contributed to Tekturna's underwhelming market performance:

• Clinical Efficacy: The drug's inability to demonstrate significant clinical superiority over existing treatments was a major hurdle. Trials such as the ALLAY and ALOFT studies showed positive results but were not enough to sway the market[1].
• Market Competition: The hypertension market is highly competitive, with well-established drugs like Diovan and other generic options. The entry of generics for Diovan further crowded the market, making it challenging for Tekturna to gain traction[1].
• Compensatory Mechanisms: The body's compensatory increase in renin secretion in response to Tekturna limited its antihypertensive capabilities, particularly at higher doses[4].

Strategic Shifts

Given the challenges, Novartis and subsequent owners like PDL BioPharma had to adjust their strategies:

• Expanded Indications: Efforts were made to broaden the approved indications for Tekturna, targeting high-risk heart attack survivors and heart failure patients. However, supportive data from ongoing trials was not expected until after the patent expiration of Diovan[1].
• Market Focus: The focus shifted towards maintaining market share and exploring other revenue streams. PDL BioPharma continued to receive significant royalties and maintained a strong market share for Tekturna in the U.S.[2].

Current Status

As of recent years, Tekturna continues to be part of the product portfolio of companies like PDL BioPharma, now operating under Noden Pharma. The drug generates revenue, albeit not at the levels initially anticipated. The company has shifted its focus towards acquiring and marketing commercial-stage products, with Tekturna being one of the key products in their portfolio[5].

Key Takeaways

• Innovative Mechanism: Tekturna's unique mechanism of action as a renin inhibitor did not translate into significant market success.
• Clinical Limitations: The drug's efficacy was limited by the body's compensatory mechanisms.
• Market Competition: The highly competitive hypertension market and the impending generic competition for Diovan were significant barriers.
• Strategic Adjustments: Companies had to adjust their strategies to maintain market share and explore other revenue streams.

FAQs

What is Tekturna, and how does it work?

Tekturna, also known as Rasilez in Europe, is a drug that directly inhibits renin, a key enzyme in the renin-angiotensin system (RAS) which regulates blood pressure.

Why did Tekturna not achieve the predicted sales?

Tekturna's sales were lower than expected due to its inability to demonstrate significant clinical superiority over existing treatments and the body's compensatory increase in renin secretion in response to the drug.

What were the major clinical trials for Tekturna?

Major trials included the ALLAY and ALOFT studies, which showed positive results but were not enough to sway the market in favor of Tekturna.

How did the patent expiration of Diovan affect Tekturna?

The patent expiration of Diovan led to increased generic competition, making it harder for Tekturna to gain market traction.

Who currently owns the rights to Tekturna?

The rights to Tekturna are currently owned by Noden Pharma, which acquired the drug from Novartis.

Sources

1. CBS News: Novartis' Blood-Pressure Drug Tekturna: A Victim of Bad Timing
2. PR Newswire: PDL BioPharma Reports 2019 Second Quarter Financial Results
3. Novartis: Novartis continues to deliver strong sales growth and core margin expansion
4. Outsourcing-Pharma: Novartis' new blood pressure drug no better than the rest?
5. Annual Reports: 2016 Annual Report - PDL BioPharma