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NUMBRINO Drug Patent Profile

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

Numbrino is a drug marketed by Omnivium Pharms and is included in one NDA. There are eleven patents protecting this drug.

The generic ingredient in NUMBRINO is cocaine hydrochloride. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cocaine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Numbrino

Numbrino was eligible for patent challenges on December 14, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 7, 2037. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NUMBRINO

US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Patent Applications:	603
Drug Prices:	Drug price information for NUMBRINO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUMBRINO
What excipients (inactive ingredients) are in NUMBRINO?	NUMBRINO excipients list
DailyMed Link:	NUMBRINO at DailyMed

See drug prices for NUMBRINO

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

NDA:

209575

Dosage:

SOLUTION;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.

US Patents and Regulatory Information for NUMBRINO

NUMBRINO is protected by eighteen 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
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes			Y
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes

NUMBRINO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Numbrino

Introduction

Numbrino, a cocaine hydrochloride nasal spray, is a significant product for Lannett Company, Inc., marking the company's first brand-name medication. Here, we delve into the market dynamics and financial trajectory of Numbrino, exploring its approval, market positioning, and the impact on Lannett Company.

FDA Approval and Market Entry

Numbrino received FDA approval on January 13, 2020, for the induction of local anesthesia of the mucous membranes during nasal operations. This approval was a milestone for Lannett Company, which has primarily been a manufacturer of generic drugs[3].

Market Positioning

Numbrino is targeted at otolaryngologists, specialists in ear, nose, and throat (ENT) procedures. The drug is not intended for retail sale but is instead distributed directly to medical professionals. This niche market positioning helps in focusing marketing efforts and ensuring that the product reaches the intended users efficiently[3].

Financial Impact on Lannett Company

The FDA approval of Numbrino had an immediate positive impact on Lannett Company's stock. The announcement led to a 5.7% increase in the company's share value, reflecting investor confidence in the product's potential[3].

Manufacturing and Expansion

Lannett Company recently received FDA approval to manufacture Numbrino at its Seymour, Indiana plant, following the sale of its Carmel, New York plant. This move is part of a broader strategy to enhance manufacturing efficiencies and expand contract development and manufacturing services. The rapid approval and transition indicate the company's capabilities and dedication to its liquid drug manufacturing segment[1].

Competitive Landscape

In the market for local anesthetics, Numbrino faces competition from other topical anesthetic products. However, its brand-name status and specific indication for nasal procedures give it a unique position. Lannett Company's experience in manufacturing generic drugs also provides a competitive edge in terms of cost and efficiency[3].

Regulatory Environment

The FDA's approval process for Numbrino was part of the agency's broader efforts to ensure timely and efficient review of new drug applications. The FDA's performance reports indicate high success rates in meeting review goals, which bodes well for companies like Lannett that are bringing new products to market[2].

Safety and Efficacy

Numbrino's safety profile includes common adverse reactions such as hypertension, tachycardia, and prolonged QT intervals. These side effects are consistent with the pharmacological properties of cocaine hydrochloride. The drug's efficacy in inducing local anesthesia has been demonstrated in clinical trials, making it a reliable option for ENT procedures[5].

Market Trends and Demand

The demand for local anesthetics in ENT procedures is steady, driven by the need for effective and safe anesthesia during surgical and diagnostic procedures. The specific use of Numbrino in nasal operations ensures a consistent market demand, particularly among otolaryngologists.

Financial Projections

While specific financial projections for Numbrino are not publicly detailed, the product's launch and subsequent manufacturing expansion at the Seymour plant are expected to enhance Lannett Company's overall manufacturing efficiencies and revenue. The company's ability to transfer production quickly and efficiently suggests that Numbrino will contribute positively to its financial performance[1].

Industry Expert Insights

Tim Crew, CEO of Lannett Company, highlighted the significance of Numbrino's approval, stating it as a "major milestone in Lannett’s 70-plus years of operations." This optimism reflects the company's confidence in the product's market potential and its contribution to the company's growth[3].

Conclusion

Numbrino represents a significant step for Lannett Company, marking its entry into the brand-name pharmaceutical market. With its targeted market positioning, efficient manufacturing transition, and positive financial impact, Numbrino is poised to contribute substantially to Lannett Company's financial trajectory.

Key Takeaways

• FDA Approval: Numbrino received FDA approval for use as a local anesthetic in nasal procedures.
• Market Positioning: Targeted at otolaryngologists, ensuring focused marketing and distribution.
• Financial Impact: Immediate positive impact on Lannett Company's stock value.
• Manufacturing Expansion: Approved for manufacture at the Seymour, Indiana plant, enhancing efficiencies.
• Competitive Landscape: Unique position in the market for local anesthetics.
• Regulatory Environment: Part of FDA's efficient review process.
• Safety and Efficacy: Demonstrated safety and efficacy in clinical trials.
• Market Trends: Steady demand driven by ENT procedures.

FAQs

Q: What is Numbrino, and what is it used for?

A: Numbrino is a cocaine hydrochloride nasal spray approved for the induction of local anesthesia of the mucous membranes during nasal operations.

Q: Who is the target market for Numbrino?

A: The target market for Numbrino is otolaryngologists, specialists in ear, nose, and throat (ENT) procedures.

Q: How did the FDA approval of Numbrino affect Lannett Company's stock?

A: The FDA approval led to a 5.7% increase in Lannett Company's share value.

Q: Where is Numbrino currently manufactured?

A: Numbrino is manufactured at Lannett Company's main plant in Seymour, Indiana.

Q: What are the common adverse reactions associated with Numbrino?

A: Common adverse reactions include hypertension, tachycardia, and prolonged QT intervals.

Sources

1. Lannett Company, Inc. - "Lannett Receives FDA Approval to Manufacture Numbrino at Seymour Plant" - PR Newswire.
2. FDA - "FY 2020 PDUFA Performance Report" - FDA.
3. Petrie-Flom Center at Harvard Law - "FDA Approves Cocaine Nasal Spray as Study Casts Doubt on FDA Standards".
4. DEA Diversion Control Division - "IQVIA Report on Stimulant Trends from 2012-2022".
5. DailyMed - "NUMBRINO- cocaine hydrochloride nasal solution".