TEKAMLO Drug Patent Profile

Which patents cover Tekamlo, and what generic alternatives are available?

Tekamlo is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-three patent family members in twenty-one countries.

The generic ingredient in TEKAMLO is aliskiren hemifumarate; amlodipine besylate. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; amlodipine besylate profile page.

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

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

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

NDA:

022545

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.

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
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-001	Aug 26, 2010		DISCN	No	No			Y
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-002	Aug 26, 2010		DISCN	No	No			Y
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-003	Aug 26, 2010		DISCN	No	No			Y
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-004	Aug 26, 2010		DISCN	No	No			Y

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	022545-003	Aug 26, 2010
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-001	Aug 26, 2010
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-002	Aug 26, 2010
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-004	Aug 26, 2010

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

Australia

Brazil

Canada

Chile

China

Colombia

Ecuador

European Patent Office

Japan

Jordan

Malaysia

Mexico

Morocco

Peru

Russian Federation

South Africa

South Korea

Taiwan

Tunisia

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
Chile	2011000594	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.
China	1117960
Japan	2012503020
Jordan	3239	تركيبات جالينية من مركبات عضوية (Galenical Formulations of Organic Compounds)
Russian Federation	2014140552	КОМБИНАЦИИ С ФИКСИРОВАННОЙ ДОЗОЙ АЛИСКИРЕНА И АМЛОДИПИНА В ФОРМЕ ДВУХСЛОЙНЫХ ИЛИ ОДНОСЛОЙНЫХ ТАБЛЕТОК

Supplementary Protection Certificates for TEKAMLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2305232	122019000098	Germany		PRODUCT NAME: ALISKIREN HEMIFUMARAT UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116
1915993	1390055-0	Sweden		PRODUCT NAME: KOMBINATION INNEFATTANDE ALISKIREN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH AMLODIPIN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/11/686/001 20110414
0678503	91564	Luxembourg		91564, EXPIRES: 20200407
2305232	C201930070	Spain		PRODUCT NAME: ALISKIREN HEMIFUMARATO + HIDROCLOROTIAZIDA; NATIONAL AUTHORISATION NUMBER: EU/1/08/491/001-080; DATE OF AUTHORISATION: 20090116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/08/491/001-080; DATE OF FIRST AUTHORISATION IN EEA: 20090116
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

Market Dynamics and Financial Trajectory for Tekamlo

Introduction

Tekamlo, a combination drug consisting of aliskiren (the only approved direct renin inhibitor) and amlodipine (a widely used calcium channel blocker), was approved by the FDA in August 2010. This approval marked a significant milestone in the treatment of high blood pressure, offering a single-pill solution for patients who often require multiple medications to manage their condition.

Approval and Initial Market Impact

The FDA approval of Tekamlo was a strategic move by Novartis to address the complex needs of patients with hypertension. David Epstein, Division Head of Novartis Pharmaceuticals, highlighted the importance of this approval, stating that it reinforced Novartis' commitment to cardiovascular research and innovative treatments[1].

Target Market and Patient Needs

Tekamlo is designed for patients who are likely to need multiple drugs to achieve their blood pressure goals. It serves as both an initial therapy and a replacement therapy for those whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone. This dual approach makes it a versatile treatment option, catering to a broad patient base.

Financial Performance of Novartis During the Launch Period

During the third quarter of 2010, Novartis reported strong financial performance, with net sales increasing by 13% (+16% in constant currencies) to $12.6 billion. The company's recently launched products, including Tekamlo, contributed significantly to this growth, generating $2.3 billion in sales, which represented 20% of total sales[2][4].

Contribution of Tekamlo to Novartis' Revenue

While specific revenue figures for Tekamlo are not detailed in the available sources, the drug was part of the portfolio of recently launched products that drove significant growth for Novartis. These products, launched since 2007, accounted for 22% of the Pharmaceuticals division's sales in the third quarter of 2010, up from 18% in the previous year[4].

Market Momentum and Competitive Landscape

The approval and launch of Tekamlo occurred during a period of strong innovation momentum for Novartis. The company saw approvals for several other key products, including Gilenya for multiple sclerosis and Tasigna for chronic myeloid leukemia. This robust pipeline and successful launches helped Novartis maintain a competitive edge in the pharmaceutical market[4].

Pricing and Economic Implications

The economics of drug development, particularly for combination therapies like Tekamlo, involve complex pricing strategies. The ability to create products that target specific patient populations, such as those with hypertension, allows firms to generate significant value. However, the pricing of such drugs must balance the need for profitability with the affordability for patients. For precision medicines and combination therapies, firms often justify higher prices due to the high value created for patients with specific conditions[3].

Operational and Financial Metrics

Novartis' financial performance during the period was marked by strong core operating income growth, which rose 25% (+29% in constant currencies) to $3.7 billion. The core operating income margin improved to 29.4% of net sales, reflecting the company's focus on productivity and operational efficiency. Free cash flow before dividends also increased, totaling $2.9 billion in the third quarter, which was an 8% increase over the previous year[2].

Long-Term Growth Prospects

The success of Tekamlo and other recently launched products contributed to Novartis' long-term growth prospects. The company's ability to execute successful large-scale launches quickly after regulatory approval was critical in meeting the diverse needs of a global patient population. This strategy positioned Novartis for continued growth and innovation in the pharmaceutical sector[4].

Key Takeaways

• FDA Approval: Tekamlo was approved in August 2010 as a single-pill combination therapy for high blood pressure.
• Market Impact: It addressed the needs of patients requiring multiple medications to manage hypertension.
• Financial Contribution: Part of Novartis' portfolio of recently launched products that drove significant revenue growth.
• Competitive Edge: Launched during a period of strong innovation momentum for Novartis.
• Pricing Strategies: Justified by the high value created for specific patient populations.
• Operational Efficiency: Contributed to Novartis' improved core operating income and free cash flow.

FAQs

Q: What is Tekamlo, and when was it approved? A: Tekamlo is a combination drug consisting of aliskiren and amlodipine, approved by the FDA in August 2010 for the treatment of high blood pressure.

Q: What patient population does Tekamlo target? A: Tekamlo is designed for patients who are likely to need multiple drugs to achieve their blood pressure goals and as a replacement therapy for those not adequately controlled with either aliskiren or amlodipine alone.

Q: How did Tekamlo contribute to Novartis' financial performance? A: Tekamlo was part of the portfolio of recently launched products that generated $2.3 billion in sales, representing 20% of Novartis' total sales in the third quarter of 2010.

Q: What other products were launched by Novartis around the same time as Tekamlo? A: Other key products launched by Novartis around the same time included Gilenya for multiple sclerosis and Tasigna for chronic myeloid leukemia.

Q: How does the pricing of combination therapies like Tekamlo impact the market? A: The pricing of such drugs is justified by the high value created for specific patient populations, balancing profitability with patient affordability.

Sources

1. FDA Approves Tekamlo - Drug Discovery and Development
2. Novartis delivers excellent performance in third quarter - FierceBiotech
3. The Economics of Drug Development: Pricing and Innovation in a Changing Market - NBER
4. Novartis delivers excellent performance in third quarter - FiercePharma
5. Novartis Group Annual Report 2010 - Novartis