OXYMETAZOLINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for oxymetazoline hydrochloride and what is the scope of patent protection?

Oxymetazoline hydrochloride is the generic ingredient in six branded drugs marketed by Taro, Mayne Pharma, Bayer Healthcare Llc, Rvl Pharms, Johnson And Johnson, and St Renatus, and is included in six NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Oxymetazoline hydrochloride has seventy-five patent family members in thirty countries.

There is one drug master file entry for oxymetazoline hydrochloride. Four suppliers are listed for this compound.

Summary for OXYMETAZOLINE HYDROCHLORIDE

International Patents:	75
US Patents:	22
Tradenames:	6
Applicants:	6
NDAs:	6
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	51
Patent Applications:	3,217
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OXYMETAZOLINE HYDROCHLORIDE
What excipients (inactive ingredients) are in OXYMETAZOLINE HYDROCHLORIDE?	OXYMETAZOLINE HYDROCHLORIDE excipients list
DailyMed Link:	OXYMETAZOLINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for OXYMETAZOLINE HYDROCHLORIDE

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

Sponsor	Phase
Milton S. Hershey Medical Center	Phase 3
Rigshospitalet, Denmark	Phase 4
University of Alabama at Birmingham	Phase 4

See all OXYMETAZOLINE HYDROCHLORIDE clinical trials

Pharmacology for OXYMETAZOLINE HYDROCHLORIDE

Drug Class	Vasoconstrictor
Physiological Effect	Increased Sympathetic Activity Vasoconstriction

Medical Subject Heading (MeSH) Categories for OXYMETAZOLINE HYDROCHLORIDE

Adrenergic alpha-Agonists

Nasal Decongestants

Sympathomimetics

Anatomical Therapeutic Chemical (ATC) Classes for OXYMETAZOLINE HYDROCHLORIDE

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for OXYMETAZOLINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RHOFADE	Topical Cream	oxymetazoline hydrochloride	1%	208552	1	2019-06-20

US Patents and Regulatory Information for OXYMETAZOLINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	10,799,481
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	10,940,138
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes	9,974,773
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	11,541,036		Y
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	9,867,808
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	10,898,573		Y
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017		RX	Yes	Yes	10,751,325

Expired US Patents for OXYMETAZOLINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017	8,420,688
Mayne Pharma	RHOFADE	oxymetazoline hydrochloride	CREAM;TOPICAL	208552-001	Jan 18, 2017	8,815,929

International Patents for OXYMETAZOLINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Japan	6030067
Spain	2750123
Brazil	112013022094	composições e métodos para o tratamento não cirúrgico da ptose
European Patent Office	3653205	OXYMETHAZOLINE POUR ADMINISTRATION TOPIQUE OCULAIRE ET SES UTILISATIONS (OXYMETHAZOLINE FOR TOPICAL OPHTHALMIC ADMINISTRATION AND USES THEREOF)
Mexico	345042	COMPOSICIONES Y MÉTODOS PARA TRATAMIENTO NO QUIRÚRGICO DE PTOSIS. (COMPOSITIONS AND METHODS FOR NON-SURGICAL TREATMENT OF PTOSIS.)
Canada	2951725
Denmark	2645993

OXYMETAZOLINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxymetazoline Hydrochloride

Introduction

Oxymetazoline hydrochloride, a widely used alpha-1A adrenoceptor agonist, is a key player in the over-the-counter (OTC) pharmaceutical market, particularly in the treatment of nasal congestion and other sinonasal symptoms. This article delves into the market dynamics and financial trajectory of oxymetazoline hydrochloride, highlighting its current status, future projections, and the factors influencing its market performance.

Market Size and Growth

The global oxymetazoline market has been experiencing steady growth. As of 2023, the market size was valued at USD 1.2 billion and is projected to reach USD 1.8 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.2% from 2024 to 2031[4].

Product Usage and Indications

Oxymetazoline hydrochloride is versatile in its applications, including:

• Nasal Decongestant: It is widely used in OTC nasal sprays to relieve nasal congestion and improve nasal airflow in patients with acute coryzal rhinitis[5].
• Rosacea Treatment: It is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults[5].
• Ophthalmic Use: It is used in the treatment of acquired blepharoptosis in adults[5].
• Off-Label Uses: It has been used during nasal intubation and ear, nose, and throat surgery to improve visualization and minimize post-operative bleeding[5].

Market Penetration and Redundancy

The OTC nasal spray market, where oxymetazoline is a dominant player, is characterized by significant redundancy. Oxymetazoline is found in 51 distinct brand name products, making it the most widely marketed active ingredient in this segment. This redundancy can confuse consumers and may lead to unnecessary or harmful use, as patients may unknowingly use multiple products containing the same active ingredient[1].

Competitive Landscape

The market for oxymetazoline hydrochloride is highly competitive, with numerous brand names and generic products available. The widespread use of oxymetazoline in various products, including well-known brands like Afrin, Mucinex, and Vicks Sinex, underscores its market dominance. However, this competition also drives innovation and pricing strategies that can impact the financial trajectory of the drug[1].

Financial Performance and Projections

The financial performance of companies involved in the production and distribution of oxymetazoline hydrochloride is influenced by several factors:

• Revenue Growth: The increasing demand for OTC nasal decongestants and other applications of oxymetazoline has contributed to steady revenue growth. For instance, the global market is expected to grow from USD 1.2 billion in 2023 to USD 1.8 billion by 2031[4].
• Cost Optimization: Companies like Santen Pharmaceutical have implemented structural reforms and cost optimization strategies, which have improved their profitability. For example, Santen achieved a significant increase in core operating profit (Core OP) by 41.9% in FY2023, partly due to cost optimization and structural reforms[2].

Regional Contributions

The market for oxymetazoline hydrochloride is not limited to any single region but is global in scope. However, regional contributions vary:

• Asia and EMEA: These regions have seen an increase in contribution profits due to revenue growth and market recovery. For instance, Santen Pharmaceutical reported increased contribution profits in China, Asia, and EMEA[2].
• Americas: Structural reforms and streamlining efforts in the Americas have also contributed to improved profitability for companies operating in this region[2].

Challenges and Risks

Despite the positive financial trajectory, there are several challenges and risks associated with the market for oxymetazoline hydrochloride:

• Regulatory Changes: Changes in laws and regulations, as well as trends in pharmaceutical administration, can impact the market. For example, price reductions and co-pay hikes for long-listed products can affect revenue[3].
• Competitive Environment: The impact of generics and reliance on mainstay products are significant risks. The success or failure of alliances with other companies and the outcome of R&D activities also play crucial roles[3].
• Consumer Awareness: The redundancy in OTC formulations and the potential for adverse reactions due to the simultaneous use of multiple medications are consumer-related challenges that need to be addressed[1].

Future Outlook

The future outlook for oxymetazoline hydrochloride is promising, driven by its diverse applications and growing demand:

• New Indications: Ongoing clinical trials, such as the one for oxymetazoline hydrochloride (STN1013800) for ptosis, which met its primary endpoint in Phase 3 in Japan, indicate potential new indications and market expansion[3].
• Market Expansion: The planned launch of new products in multiple countries and the continued refinement of organizational capabilities by companies like Santen Pharmaceutical are expected to further boost the market[3].

Key Takeaways

• Market Growth: The global oxymetazoline market is projected to grow at a CAGR of 5.2% from 2024 to 2031.
• Product Versatility: Oxymetazoline hydrochloride is used in various applications, including nasal decongestants, rosacea treatment, and ophthalmic use.
• Market Redundancy: The OTC nasal spray market is characterized by significant redundancy, with oxymetazoline being the most widely marketed active ingredient.
• Financial Performance: Companies involved in the production and distribution of oxymetazoline hydrochloride have seen improved profitability through cost optimization and structural reforms.
• Regional Contributions: Asia, EMEA, and the Americas contribute significantly to the market, with varying growth patterns.

FAQs

1. What are the primary uses of oxymetazoline hydrochloride?

   • Oxymetazoline hydrochloride is primarily used as a nasal decongestant, for the treatment of rosacea, and in ophthalmic applications.

2. How large is the global oxymetazoline market?

   • As of 2023, the global oxymetazoline market was valued at USD 1.2 billion and is expected to reach USD 1.8 billion by 2031.

3. What are the risks associated with the use of oxymetazoline hydrochloride?

   • Risks include rebound congestion, tachyphylaxis, and potential adverse reactions from the simultaneous use of multiple medications.

4. Which companies are major players in the oxymetazoline hydrochloride market?

   • Companies like Santen Pharmaceutical, along with various other pharmaceutical firms, are major players in this market.

5. What are the future prospects for oxymetazoline hydrochloride?

   • The future outlook is promising, with potential new indications, market expansion, and continued growth driven by diverse applications.

Sources

1. Redundancy of Pharmacologic Ingredients in Over‐the‐Counter Nasal Sprays - PMC
2. FY2023 Financial Results - Santen Pharmaceutical
3. Capital Markets Day Overseas Business - Santen Pharmaceutical
4. Oxymetazoline Market Size, Share, Industry Report 2024-31 - Market Research Intellect
5. Oxymetazoline: Uses, Interactions, Mechanism of Action - DrugBank