~ Buy the QNASL (beclomethasone dipropionate) Drug Profile, 2024 PDF Report in the Report Store ~

QNASL Drug Patent Profile

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

Qnasl is a drug marketed by Teva Branded Pharm and is included in one NDA. There are two patents protecting this drug.

This drug has fifty-three patent family members in thirty-two countries.

The generic ingredient in QNASL is beclomethasone dipropionate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the beclomethasone dipropionate profile page.

DrugPatentWatch^® Generic Entry Outlook for Qnasl

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 24, 2027. This may change due to patent challenges or generic licensing.

There is one tentative approval for the generic drug (beclomethasone dipropionate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for QNASL

International Patents:	53
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Patent Applications:	4,697
Drug Prices:	Drug price information for QNASL
What excipients (inactive ingredients) are in QNASL?	QNASL excipients list
DailyMed Link:	QNASL at DailyMed

See drug prices for QNASL

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

NDA:

202813

Dosage:

AEROSOL, 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.

Pharmacology for QNASL

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for QNASL

QNASL is protected by two 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
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-002	Dec 17, 2014		RX	Yes	No			Y
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012		RX	Yes	Yes			Y
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-002	Dec 17, 2014		RX	Yes	No			Y
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012		RX	Yes	Yes			Y

Expired US Patents for QNASL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-002	Dec 17, 2014
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012

International Patents for QNASL

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

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	023795	НАЗАЛЬНОЕ РАСПЫЛИТЕЛЬНОЕ УСТРОЙСТВО (NASAL SPRAY DEVICE)
South Africa	8909290
European Patent Office	0653204	Formulations d'aérosols à usage médical (Medicinal aerosol formulations)
Hong Kong	130397	Aerosol formulation comprising beclomethasone 17,21 dipropionate
Denmark	2926855
Canada	2814212	DISPOSITIF DE PULVERISATION NASALE (NASAL SPRAY DEVICE)

QNASL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for QNASL

Introduction to QNASL

QNASL, marketed by Teva Branded Pharm, is a prescription corticosteroid medication in the form of a nasal aerosol. It contains the active ingredient beclomethasone dipropionate and is used to treat seasonal and perennial allergic rhinitis in adults and children[2][4].

Regulatory and Patent Landscape

QNASL is protected by two patents in the United States and has a total of 53 patent family members across 32 countries. The earliest estimated date for generic entry is January 24, 2027, although this could change due to patent challenges or generic licensing agreements[1].

Market Approval and Launch

QNASL received FDA approval on March 23, 2012, and was made available by prescription in April 2012. It was the first nonaqueous or “dry-mist” nasal aerosol product in its category, which reports annual sales of $2.5 billion[4].

Therapeutic Applications

QNASL is specifically designed to treat symptoms associated with seasonal and perennial allergic rhinitis (SAR and PAR). Clinical data have shown that QNASL provides nasal symptom relief in patients with SAR and PAR, including improvements in quality of life and sleep quality[4].

Market Size and Growth

The global nasal drug delivery technology market, which includes products like QNASL, was valued at USD 71.89 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 7.45% from 2023 to 2030. This growth is driven by increasing preference for alternative modes of drug administration and the rising incidence of chronic diseases[3].

Segment Performance

Within the nasal drug delivery technology market, nasal aerosols like QNASL are part of the non-pressurized container segment, which led the market with a revenue share of over 85% in 2022. The segment is expected to continue growing due to the demand for related products and the advantages of non-pressurized containers[3].

Geographic Dominance

North America dominates the nasal drug delivery technology market, holding a share of 34.85% in 2022. This dominance is attributed to the high prevalence of diseases and significant investments in research and development for novel drug delivery technologies[3].

Competitive Landscape

QNASL operates in a competitive market with several key players, including Teva, Cipla, and Chiesi. The market for beclomethasone dipropionate, the active ingredient in QNASL, is projected to expand significantly from 2021 to 2031, driven by increasing demand for treatments of asthma and allergic rhinitis[5].

Financial Projections

While specific financial projections for QNASL are not publicly detailed, the overall market for nasal drug delivery technologies and beclomethasone dipropionate is expected to see significant growth. The global beclomethasone dipropionate market is projected to continue its upward trend, driven by market dynamics such as increasing disease prevalence and advancements in drug delivery technologies[3][5].

Generic Entry and Market Impact

The potential for generic entry in 2027 could significantly impact QNASL's market share and revenue. Generic competition often leads to price reductions and increased market competition, which can affect the financial trajectory of branded products. However, Teva's strategic positioning and the unique features of QNASL, such as its nonaqueous aerosol delivery system, may help mitigate some of these effects[1].

Conclusion

QNASL is a significant player in the nasal drug delivery technology market, particularly in the treatment of allergic rhinitis. With a strong regulatory and patent position, QNASL is poised to continue its market presence until the potential generic entry in 2027. The overall market growth driven by increasing demand for alternative drug delivery methods and the rising incidence of chronic diseases supports a positive financial trajectory for QNASL in the near term.

Key Takeaways

• Regulatory Protection: QNASL is protected by two U.S. patents and 53 international patent family members.
• Market Approval: FDA-approved in 2012, QNASL was the first nonaqueous nasal aerosol in its category.
• Therapeutic Applications: Treats seasonal and perennial allergic rhinitis with benefits in quality of life and sleep quality.
• Market Growth: Part of a growing nasal drug delivery technology market expected to reach USD 127.12 billion by 2030.
• Generic Entry: Potential generic entry in 2027 could impact market share and revenue.
• Geographic Dominance: North America leads the market due to high disease prevalence and R&D investments.

FAQs

Q: What is QNASL used for? A: QNASL is used to treat seasonal and perennial allergic rhinitis in adults and children.

Q: When was QNASL approved by the FDA? A: QNASL was approved by the FDA on March 23, 2012.

Q: What is the active ingredient in QNASL? A: The active ingredient in QNASL is beclomethasone dipropionate.

Q: What is the estimated date for generic entry of QNASL? A: The estimated date for generic entry is January 24, 2027.

Q: How does QNASL differ from other nasal aerosols? A: QNASL is the first nonaqueous or “dry-mist” nasal aerosol in its category, using an environmentally friendly propellant (HFA) and containing a built-in dose counter.

Sources

1. DrugPatentWatch - QNASL Drug Patent Profile
2. Teva Pharmaceuticals - FDA Approval of QNASL
3. Grand View Research - Nasal Drug Delivery Technology Market Size Analysis Report 2030
4. Teva Pharmaceuticals - Additional QNASL Data to be Presented at Annual Allergy Meeting
5. Market Research Intellect - Beclomethasone Dipropionate Market Size And Forecast