Levocetirizine dihydrochloride - Generic Drug Details

What are the generic sources for levocetirizine dihydrochloride and what is the scope of freedom to operate?

Levocetirizine dihydrochloride is the generic ingredient in four branded drugs marketed by Apotex, Chartwell Molecular, Padagis Us, Taro, Hetero Labs Ltd Iii, Chattem Sanofi, Dr Reddys, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules, Ipca Labs Ltd, Macleods Pharms Ltd, Micro Labs, Micro Labs Ltd India, Perrigo R And D, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, and Us Antibiotics, and is included in twenty-eight NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Levocetirizine dihydrochloride has thirty patent family members in twenty-four countries.

There are eleven drug master file entries for levocetirizine dihydrochloride. Fifty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for levocetirizine dihydrochloride

International Patents:	30
US Patents:	1
Tradenames:	4
Applicants:	21
NDAs:	28
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	51
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	67
Patent Applications:	290
Drug Prices:	Drug price trends for levocetirizine dihydrochloride
Drug Sales Revenues:	Drug sales revenues for levocetirizine dihydrochloride
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for levocetirizine dihydrochloride
What excipients (inactive ingredients) are in levocetirizine dihydrochloride?	levocetirizine dihydrochloride excipients list
DailyMed Link:	levocetirizine dihydrochloride at DailyMed

See drug prices for levocetirizine dihydrochloride

See drug sales revenues for levocetirizine dihydrochloride

Recent Clinical Trials for levocetirizine dihydrochloride

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

Sponsor	Phase
Eurofarma Laboratorios S.A.	Phase 3
Osama Mohamed Hassan Ibrahim , Prof Clinical pharmacy Department- Tanta University	Phase 2
Mostafa Bahaa	Phase 2

See all levocetirizine dihydrochloride clinical trials

Generic filers with tentative approvals for LEVOCETIRIZINE DIHYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		2.5MG/5ML	SOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for levocetirizine dihydrochloride

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for levocetirizine dihydrochloride

R06AE	Piperazine derivatives
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

R06AE	Piperazine derivatives
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for LEVOCETIRIZINE DIHYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XYZAL	Oral Solution	levocetirizine dihydrochloride	0.5 mg/mL	022157	1	2009-01-14
XYZAL	Tablets	levocetirizine dihydrochloride	5 mg	022064	1	2007-12-17

US Patents and Regulatory Information for levocetirizine dihydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	SOLUTION;ORAL	022157-001	Jan 28, 2008		DISCN	Yes	No
Granules	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	TABLET;ORAL	090486-001	Mar 26, 2013		DISCN	No	No
Micro Labs Ltd India	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	TABLET;ORAL	202046-001	Sep 17, 2013	AB	RX	No	No
Hetero Labs Ltd Iii	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	TABLET;ORAL	091264-001	Jun 29, 2012	AB	RX	No	No
Chartwell Molecular	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	SOLUTION;ORAL	204599-001	May 15, 2017	AA	RX	No	No
Padagis Us	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	SOLUTION;ORAL	091263-001	Nov 7, 2011	AA	RX	No	Yes
Sun Pharm	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	TABLET;ORAL	090362-001	Jan 31, 2013	AB	RX	No	No

Expired US Patents for levocetirizine dihydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	SOLUTION;ORAL	022157-001	Jan 28, 2008
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064-001	May 25, 2007
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064-001	May 25, 2007

International Patents for levocetirizine dihydrochloride

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	012463	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ПРОИЗВОДНЫЕ ПИПЕРАЗИНА (PHARMACEUTICAL COMPOSITION CONTAINING PIPERAZINE DERIVATIVES)
Japan	2008505949
World Intellectual Property Organization (WIPO)	2006005507
Eurasian Patent Organization	200700067	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ПРОИЗВОДНЫЕ ПИПЕРАЗИНА
Taiwan	I304339
Portugal	1768649
Austria	E443512

Supplementary Protection Certificates for levocetirizine dihydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0663828	C300085	Netherlands		PRODUCT NAME: LEVOCETIRIZINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LEVOCETIRINE DIHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 26770 20011009; FIRST REGISTRATION: DE 49903.00.00 AND 49904.00.00 20010103
0058146	2001C/045	Belgium		PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103

Levocetirizine dihydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Levocetirizine Dihydrochloride

Market Overview

Levocetirizine dihydrochloride, a popular antihistamine used to treat allergic rhinitis and other allergic conditions, has been experiencing significant market dynamics that shape its financial trajectory.

Global Market Size and Growth

As of 2023, the global Levocetirizine Dihydrochloride market volume was approximately 4 thousand tonnes. This market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 10.45% until 2034, indicating a robust expansion in the coming years[1].

Regional Consumption

North America stands as the largest consumer of Levocetirizine Dihydrochloride globally. This region's demand is driven by a high prevalence of allergic conditions and a well-established healthcare system[1].

Market Segmentation

The Levocetirizine Hydrochloride market is segmented based on type (oral liquid, tablet) and application (hospitals, drugstores, others), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). This segmentation helps in understanding the diverse market dynamics and opportunities across different regions and sectors[3].

Price Trends

In recent months, the prices of Levocetirizine Dihydrochloride have experienced a notable decline in Western markets. This decline is attributed to several factors, including sufficient stock levels among end-users, reduced demand, and economic challenges. For instance, in May 2024, prices dropped due to decreased purchases and economic woes in Western markets[2].

Factors Influencing Price Decline

• Inventory Levels: End-users having sufficient stocks on hand reduced the need for additional purchases, leading to fewer transactions and lower prices[2].
• Economic Conditions: Slowing economic activities, such as the decline in China's manufacturing PMI and the sluggish eurozone economy, have contributed to the downward trend in prices[2].
• Regulatory Changes: In India, the National Pharmaceutical Pricing Authority (NPPA) reduced retail prices for essential drugs, including Levocetirizine Dihydrochloride, which has also impacted global prices[2].

Future Outlook

Despite the current decline, there is a potential rebound in Levocetirizine Dihydrochloride prices anticipated in the coming months. This rebound is expected due to heightened purchases by end-consumers and possible reductions in interest rates by central banks, which could alleviate financial pressures on consumers and boost market activity[2].

Economic and Market Drivers

• Demand from Emerging Markets: Growing demand from emerging economies, particularly in Asia-Pacific, is expected to drive the market forward.
• Increasing Prevalence of Allergies: The rising prevalence of allergic conditions globally is a significant driver for the Levocetirizine Dihydrochloride market.
• Pharmaceutical Pricing Strategies: Competitive pricing strategies and regulatory changes can significantly impact market dynamics[3].

Challenges and Restraints

• Economic Uncertainty: Economic downturns and inflationary pressures can dampen consumer sentiment and reduce demand.
• Regulatory Changes: Changes in pharmaceutical pricing regulations, such as those implemented by the NPPA in India, can affect global market prices[2].

Competitive Landscape

The Levocetirizine Hydrochloride market is characterized by a mix of established and emerging players. The report includes extensive lists of prominent companies, their market entry years, and various market-related factors. This competitive landscape is crucial for understanding market dynamics and potential future developments[3].

Financial Impact on Healthcare

Levocetirizine has been shown to improve quality of life and reduce the overall costs of treating allergic conditions. A study by the World Health Organization initiative found that levocetirizine significantly improved symptoms and decreased the overall costs of the disease over a 6-month treatment period[5].

Pharmacoeconomic Benefits

• Reduced Healthcare Costs: By improving symptoms and reducing the need for other treatments, levocetirizine can lower the overall healthcare costs associated with allergic conditions.
• Improved Quality of Life: The improvement in quality of life for patients translates into better productivity and reduced absenteeism, further contributing to economic benefits[5].

Market Forecast and Projections

The Levocetirizine Hydrochloride market is expected to undergo significant growth from 2023 to 2031. The market size is projected to increase substantially, driven by robust growth rates and favorable market dynamics. The comprehensive assessment of the market includes an examination of drivers, restraints, opportunities, and challenges, providing a clear outlook on the market's evolution[3].

"The Levocetirizine Hydrochloride market has undergone swift and considerable growth in recent times, and projections affirm that this notable expansion will endure from 2023 to 2031."[3]

Key Takeaways

• The global Levocetirizine Dihydrochloride market is growing at a CAGR of 10.45% until 2034.
• North America is the largest consumer of Levocetirizine Dihydrochloride.
• Recent price declines are due to sufficient inventory levels, economic challenges, and regulatory changes.
• A potential rebound in prices is anticipated due to increased consumer purchases and possible interest rate reductions.
• The market is driven by increasing demand from emerging markets and the growing prevalence of allergies.
• Regulatory changes and economic uncertainty are key challenges.

FAQs

Q: What is the current global market size of Levocetirizine Dihydrochloride in terms of volume?

A: The global market size of Levocetirizine Dihydrochloride was approximately 4 thousand tonnes in 2023[1].

Q: Which region is the largest consumer of Levocetirizine Dihydrochloride?

A: North America is the largest consumer of Levocetirizine Dihydrochloride globally[1].

Q: Why have the prices of Levocetirizine Dihydrochloride declined recently?

A: Prices have declined due to sufficient inventory levels among end-users, reduced demand, and economic challenges in Western markets[2].

Q: What are the expected future trends for the Levocetirizine Dihydrochloride market?

A: The market is expected to rebound due to heightened purchases by end-consumers and possible reductions in interest rates by central banks[2].

Q: How does Levocetirizine Dihydrochloride impact healthcare costs?

A: Levocetirizine Dihydrochloride improves quality of life and reduces the overall costs of treating allergic conditions by improving symptoms and reducing the need for other treatments[5].

Sources:

1. ChemAnalyst, Levocetirizine Dihydrochloride Market Size, Share & Forecast 2034.
2. ChemAnalyst, Levocetirizine Dihydrochloride Prices Plunge in Western Markets Amid Slowing Demand, Economic Woe.
3. Market Research Intellect, Levocetirizine Hydrochloride Market Size, Scope And Forecast Report.
4. ChemAnalyst, Lovocetirizine Dihydrochloride Prices, Monitor & Demand.
5. PubMed, Levocetirizine improves quality of life and reduces costs in long-term treatment of persistent allergic rhinitis.