OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for oxymetazoline hydrochloride; tetracaine hydrochloride and what is the scope of freedom to operate?

Oxymetazoline hydrochloride; tetracaine hydrochloride is the generic ingredient in one branded drug marketed by St Renatus and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Oxymetazoline hydrochloride; tetracaine hydrochloride has twenty-six patent family members in sixteen countries.

Summary for OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

International Patents:	26
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	8
DailyMed Link:	OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

9,308,191

Dosage:

SPRAY, METERED;NASAL

^*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 OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

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

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 4
Dow University of Health Sciences	Early Phase 1
Louisiana State University Health Sciences Center in New Orleans	Phase 4

See all OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

C05AD	Local anesthetics
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D04AB	Anesthetics for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

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

N01BA	Esters of aminobenzoic acid
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

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

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
St Renatus	KOVANAZE	oxymetazoline hydrochloride; tetracaine hydrochloride	SPRAY, METERED;NASAL	208032-001	Jun 29, 2016		RX	Yes	Yes	9,308,191		Y
St Renatus	KOVANAZE	oxymetazoline hydrochloride; tetracaine hydrochloride	SPRAY, METERED;NASAL	208032-001	Jun 29, 2016		RX	Yes	Yes	8,580,282		Y

Expired US Patents for OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
St Renatus	KOVANAZE	oxymetazoline hydrochloride; tetracaine hydrochloride	SPRAY, METERED;NASAL	208032-001	Jun 29, 2016	6,413,499

International Patents for OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201171215	СТОМАТОЛОГИЧЕСКОЕ АНЕСТЕЗИРУЮЩЕЕ СРЕДСТВО ДЛЯ ИНТРАНАЗАЛЬНОГО ВВЕДЕНИЯ, СОДЕРЖАЩЕЕ ТЕТРАКАИН И ВАЗОКОНСТРИКТОР
Eurasian Patent Organization	024184	СТОМАТОЛОГИЧЕСКОЕ АНЕСТЕЗИРУЮЩЕЕ СРЕДСТВО ДЛЯ ИНТРАНАЗАЛЬНОГО ВВЕДЕНИЯ, СОДЕРЖАЩЕЕ ТЕТРАКАИН И ВАЗОКОНСТРИКТОР (DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION)
Australia	2015242984	Dental Anesthetic Comprising Tetracaine and a Vasoconstrictor For Intranasal Administration
Japan	2017031226	鼻腔内投与用のテトラカインおよび血管収縮薬を含む歯科用麻酔剤 (DENTAL ANESTHETIC COMPRISING TETRACAINE AND VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION)
Denmark	2413899
Mexico	2011010445	ANESTESICO DENTAL QUE COMPRENDE TETRACAINA Y UN VASOCONSTRICTOR PARA ADMINISTRACION INTRANASAL. (DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION.)

OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxymetazoline Hydrochloride and Tetracaine Hydrochloride

Introduction to Oxymetazoline and Tetracaine

Oxymetazoline hydrochloride and tetracaine hydrochloride are two pharmaceutical compounds that have garnered significant attention in various medical fields. Oxymetazoline, an alpha-1A adrenoceptor agonist, is widely used as a nasal decongestant and for treating conditions such as allergic rhinitis, rosacea, and acquired blepharoptosis[4]. Tetracaine, a local anesthetic, is often combined with oxymetazoline for dental anesthesia.

Market Growth Drivers for Oxymetazoline

The market for oxymetazoline is driven by several key factors:

Increasing Prevalence of Allergies

The global rise in allergic diseases, particularly allergic rhinitis, is a significant driver. Environmental pollution, urbanization, and changing lifestyles have contributed to the increasing incidence of allergies, making oxymetazoline a sought-after solution for nasal congestion[1].

Convenience and Accessibility

The availability of over-the-counter (OTC) nasal sprays containing oxymetazoline has increased its adoption. Online pharmacies and e-commerce platforms have further eased access to these products, contributing to market growth[1].

Innovations in Product Formulations

Recent innovations, such as extended-release formulations and combination products with other active ingredients like corticosteroids, have enhanced the effectiveness and safety profiles of oxymetazoline products. Advanced misting technology in nasal sprays has also improved user experience[1].

Market Expansion in Emerging Economies

The oxymetazoline market is not only growing in established markets like North America and Europe but also in emerging economies. Countries in the Asia-Pacific, Latin America, and the Middle East are experiencing rising demand due to increasing awareness about allergies and better access to healthcare. The growing middle class in countries like India and China is particularly driving the demand for OTC products, including oxymetazoline nasal sprays[1].

Role of Tetracaine in Combination Products

Tetracaine, when combined with oxymetazoline, plays a crucial role in dental anesthesia. The intranasal formulation of 3% tetracaine and 0.05% oxymetazoline (Kovanaze) has been FDA-approved for providing sufficient local anesthesia for dental restorative procedures. This combination leverages the vasoconstrictive action of oxymetazoline to enhance the anesthetic effect of tetracaine[2].

Financial Trajectory

Current Market Trends

The financial trajectory of oxymetazoline and tetracaine combination products is promising due to the growing demand for allergy treatments and dental anesthesia. The global oxymetazoline market is expected to accelerate its growth as more consumers seek fast and effective solutions for nasal congestion and other allergic reactions[1].

Impact of Regulatory Changes

Regulatory changes, such as those introduced by the Inflation Reduction Act, are expected to influence the broader pharmaceutical market. While these provisions primarily affect Medicare and prescription drug spending, they indicate a trend towards more controlled and affordable healthcare, which could indirectly benefit OTC products like oxymetazoline by increasing consumer awareness and demand for self-care solutions[3].

Investment Opportunities

The growing market for oxymetazoline presents significant investment opportunities, particularly in emerging economies. Companies are increasingly forming partnerships and collaborations to innovate and expand their product lines, which is expected to fuel further market growth. New product innovations and advancements in delivery systems are also attracting investors looking to capitalize on the rising demand for allergy treatments and dental anesthesia[1].

Challenges and Considerations

Safety and Long-term Use

While oxymetazoline provides effective short-term relief, long-term use should be avoided due to potential side effects such as rebound congestion. This necessitates continuous education and awareness campaigns to ensure responsible use of these products[1].

Side Effects and Adverse Reactions

The combination of tetracaine and oxymetazoline can cause side effects like nasal runniness, stuffiness, and stinging. Cardiovascular parameters can also be affected, particularly in individuals with certain medical conditions, highlighting the need for careful patient selection and monitoring[2].

Future Outlook

The future outlook for oxymetazoline and tetracaine combination products is positive, driven by increasing demand for effective and convenient treatments. As innovations continue and more products enter the market, these compounds are expected to remain pivotal in the allergy treatment and dental anesthesia sectors.

Key Takeaways

• Growing Demand: The global demand for allergy treatments and dental anesthesia is driving the market growth for oxymetazoline and tetracaine.
• Emerging Markets: Emerging economies are experiencing a rise in demand due to increasing awareness and better healthcare access.
• Innovations: New product formulations and delivery systems are enhancing user experience and driving market expansion.
• Regulatory Impact: Regulatory changes are influencing the broader pharmaceutical market, potentially benefiting OTC products.
• Investment Opportunities: The market presents significant investment opportunities, particularly in emerging economies and through partnerships and innovations.

FAQs

1. What are the primary uses of oxymetazoline? Oxymetazoline is used as a nasal decongestant, for treating persistent facial erythema associated with rosacea, and for acquired blepharoptosis. It is also used in combination with tetracaine for dental anesthesia[4].

2. How does the combination of tetracaine and oxymetazoline work in dental anesthesia? The combination leverages the vasoconstrictive action of oxymetazoline to enhance the anesthetic effect of tetracaine, providing sufficient local anesthesia for dental restorative procedures[2].

3. What are the potential side effects of long-term oxymetazoline use? Long-term use of oxymetazoline can lead to rebound congestion and other side effects, making it important to use these products responsibly and as directed[1].

4. How is the oxymetazoline market expanding globally? The market is expanding in emerging economies due to increasing awareness about allergies, improving healthcare access, and growing consumer incomes[1].

5. What regulatory changes could impact the market for oxymetazoline and tetracaine? Regulatory changes, such as those introduced by the Inflation Reduction Act, could indirectly benefit OTC products by increasing consumer awareness and demand for self-care solutions[3].

Cited Sources:

1. Market Research Intellect - Oxymetazoline Market Size And Projection[1]
2. PubMed - Intranasal tetracaine and oxymetazoline: a newly approved drug[2]
3. Health System Tracker - Recent and Forecasted Trends in Prescription Drug Spending[3]
4. DrugBank - Oxymetazoline: Uses, Interactions, Mechanism of Action[4]
5. FDA - 208032Orig1s000 - Kovanaze Mist (3% tetracaine HCl/0.05% oxymetazoline HCl)[5]