VALTURNA Drug Patent Profile

When do Valturna patents expire, and when can generic versions of Valturna launch?

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

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

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

DrugPatentWatch^® Generic Entry Outlook for Valturna

Valturna 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 3, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VALTURNA

International Patents:	93
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	6
DailyMed Link:	VALTURNA at DailyMed

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

Constraining patent/regulatory exclusivity:

8,168,616

NDA:

022217

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 VALTURNA

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

Sponsor	Phase
Novartis Pharmaceuticals	Phase 4

See all VALTURNA clinical trials

US Patents and Regulatory Information for VALTURNA

VALTURNA is protected by one US patents.

This potential generic entry date is based on patent 8,168,616.

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	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-001	Sep 16, 2009		DISCN	No	No	8,168,616		Y
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009		DISCN	No	No	8,168,616		Y

Expired US Patents for VALTURNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009	5,399,578
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-001	Sep 16, 2009	5,399,578
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009	5,559,111
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-001	Sep 16, 2009	5,559,111

International Patents for VALTURNA

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

Country	Patent Number	Title	Estimated Expiration
Germany	59506707
Norway	2011020
Ireland	71155	Acyl compounds
Spain	2256335
New Zealand	237126	SUBSTITUTED BIPHENYLYL ALKYLAMIDES, SULPHONAMIDES AND CARBAMIC ACID ESTER DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS
China	1153759
European Patent Office	2305231

Supplementary Protection Certificates for VALTURNA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0678503	300296	Netherlands		300296, 20150407, EXPIRES: 20200406
1915993	2013/058	Ireland		2013/058 DECLARED INVALID WITH ARTICLE 15 1C OF REGULATION EC NO. 469/2009
1602370	SZ 11/2009	Austria		PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0678503	C00678503/04	Switzerland		PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
1602370	2009/010	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/08/491/001-EU/1/08/491/080 20090116; FIRST REGISTRATION NO/DATE: 58935 01 58935 02 58935 03 58935 04 20081028

Market Dynamics and Financial Trajectory for the Drug: Valturna

Introduction to Valturna

Valturna, a combination drug consisting of aliskiren and valsartan, was developed for the treatment of hypertension. It was designed to lower blood pressure and reduce the risk of fatal and nonfatal cardiovascular events such as strokes and myocardial infarctions[4].

Historical Context and Market Entry

Valturna was introduced to the market as a potential solution for patients who required multiple drugs to achieve their blood pressure goals. However, its market presence was short-lived due to concerns regarding potential side effects, particularly in diabetic patients and those with kidney impairment. As a result, Valturna was withdrawn from the U.S. market in 2012[4].

Factors Influencing Market Dynamics

Safety Concerns and Regulatory Actions

The primary factor that influenced the market dynamics of Valturna was the safety concerns associated with its use. Clinical trials revealed higher incidence rates of hyperkalemia (elevated serum potassium levels) and other adverse events, which led to its withdrawal from the market. Regulatory actions, including warnings and precautions issued by the FDA, further impacted its market viability[5].

Competitive Landscape

The antihypertensive drug market is highly competitive, with various classes of drugs available, including diuretics, ACE inhibitors, calcium channel blockers, and angiotensin receptor blockers (ARBs) like valsartan. Valturna's combination of aliskiren and valsartan was intended to offer a unique therapeutic benefit, but it failed to gain long-term traction due to safety issues[3].

Demand and Supply

Although Valturna is no longer available in the market, the demand for its components, particularly valsartan, remains high. Valsartan prices have surged globally due to rising demand and supply constraints, especially in regions like India and China. This surge is driven by robust sales in key therapeutic segments and regulatory changes affecting pricing strategies[1].

Financial Trajectory

Initial Market Performance

When Valturna was first introduced, it was expected to capture a significant share of the antihypertensive market due to its combination therapy benefits. However, the financial performance was short-lived and did not meet expectations due to the rapid emergence of safety concerns.

Withdrawal and Financial Impact

The withdrawal of Valturna from the market in 2012 had a significant financial impact on the companies involved. The investment in research, development, and marketing was not recouped, leading to financial losses. Additionally, the need to address and mitigate the risks associated with the drug further added to the financial burden[4].

Current Market Implications

Although Valturna itself is no longer a market player, the components of the drug continue to influence market dynamics. Valsartan, for instance, remains a crucial medication in the treatment of hypertension, and its pricing dynamics are closely watched. The surge in valsartan prices due to demand and supply constraints highlights the ongoing financial implications of the original drug's components[1].

Impact on Related Markets

Aliskiren Market

The aliskiren market, while not directly impacted by Valturna's withdrawal, continues to grow moderately. Aliskiren's effectiveness in controlling hypertension, especially when combined with other antihypertensive drugs, drives its market growth. However, high production costs and supply constraints are factors that could potentially limit its expansion[3].

Valsartan Market

The valsartan market has seen significant growth and price surges due to increased demand and supply constraints. This trend is expected to continue, driven by robust sales in key therapeutic segments and regulatory changes affecting pricing strategies. The Indian and Chinese markets, in particular, have seen a rebound in pharmaceutical sales, contributing to the upward trajectory of valsartan prices[1].

Future Outlook

Lessons Learned

The experience with Valturna highlights the importance of thorough safety evaluations and robust clinical trials before market entry. It also underscores the need for continuous monitoring of drug safety post-marketing.

Market Trends

The antihypertensive market is expected to continue growing, driven by increasing health awareness and government initiatives. However, the focus will be on drugs with proven safety profiles and effective therapeutic outcomes.

Financial Projections

For drugs like valsartan, which continue to be in high demand, financial projections indicate sustained growth. However, the market will remain sensitive to supply chain disruptions, regulatory changes, and any new safety concerns that may arise.

Key Takeaways

• Safety Concerns: Valturna's withdrawal from the market was primarily due to safety concerns, highlighting the critical importance of drug safety.
• Market Dynamics: The antihypertensive market is highly competitive, with demand and supply dynamics significantly influencing drug prices.
• Financial Impact: The financial trajectory of Valturna was negatively impacted by its withdrawal, while its components continue to influence market financials.
• Future Outlook: The market will focus on safe and effective treatments, with ongoing monitoring and regulatory oversight.

FAQs

What was the primary reason for Valturna's withdrawal from the market?

Valturna was withdrawn from the market due to concerns regarding potential side effects, particularly in diabetic patients and those with kidney impairment.

How has the valsartan market been affected by the withdrawal of Valturna?

Despite Valturna's withdrawal, the valsartan market has seen significant growth and price surges due to increased demand and supply constraints.

What are the key factors driving the growth of the aliskiren market?

The aliskiren market is driven by its effectiveness in controlling hypertension, the ability to combine it with other antihypertensive drugs, and increasing health awareness and government initiatives.

What are the potential financial implications for companies involved in the antihypertensive drug market?

Companies in this market may face financial implications due to supply chain disruptions, regulatory changes, and any new safety concerns that may arise.

How does the current market trend affect the pricing of antihypertensive drugs like valsartan?

The current market trend, characterized by high demand and supply constraints, has led to a surge in valsartan prices globally.

Sources

1. ChemAnalyst: "Valsartan Prices Surge Globally, Driven by Rising Demand and Supply Constraints"
2. FDA: "Valturna Label"
3. Verified Market Research: "Aliskiren Market Size, Share, Scope, Trends, Opportunities & Forecast"
4. RxList: "Valturna (Aliskiren and Valsartan, USP Tablets)"
5. FDA: "Valturna Label - 3081332"

Last updated: 2024-12-17