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goprelto Drug Patent Profile

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

Goprelto is a drug marketed by Noden Pharma and is included in one NDA. There are twelve patents protecting this drug.

The generic ingredient in GOPRELTO 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 Goprelto

Goprelto 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 goprelto

US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	1
Patent Applications:	581
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for goprelto
What excipients (inactive ingredients) are in goprelto?	goprelto excipients list
DailyMed Link:	goprelto at DailyMed

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

Constraining patent/regulatory exclusivity:

10,016,407

NDA:

209963

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.

Recent Clinical Trials for goprelto

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

Sponsor	Phase
Pharmaceutical Project Solutions, Inc.	Phase 4

See all goprelto clinical trials

US Patents and Regulatory Information for goprelto

goprelto is protected by fifteen US patents.

This potential generic entry date is based on patent 10,016,407.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting goprelto

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Noden Pharma	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	10,016,407
Noden Pharma	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	10,149,843
Noden Pharma	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	10,894,012
Noden Pharma	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	10,231,961		Y
Noden Pharma	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	9,867,815
Noden Pharma	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	10,420,760

Goprelto Market dynamics and financial trajectory  ⇩ Experimental

Market Dynamics and Financial Trajectory for Goprelto

Introduction

Goprelto, a cocaine hydrochloride nasal spray, is a unique pharmaceutical product approved by the FDA for use as a local anesthetic and vasoconstrictor, particularly in diagnostic and therapeutic procedures involving the nasal, oral, and laryngeal cavities. Here, we delve into the market dynamics and financial trajectory of Goprelto, highlighting key factors that influence its market position and financial performance.

FDA Approval and Market Entry

In 2017, the FDA granted approval for Goprelto, marking a significant milestone for its manufacturer, Genus Pharmaceuticals. This approval was crucial as it validated the product's safety and efficacy, paving the way for its entry into the market[1][2].

Competitive Landscape

Goprelto competes directly with C-Topical, a cocaine hydrochloride solution produced by Lannett. However, unlike C-Topical, Goprelto is the only FDA-approved cocaine hydrochloride product for nasal use, making it a distinct player in the market. The competition between these two products has been intense, with allegations of false advertising against Lannett, which claimed that C-Topical was FDA-approved and had broader uses than it actually did[1].

Market Impact of False Advertising

The false advertising claims by Lannett significantly impacted the market dynamics. Genus alleged that Lannett's misleading statements led to a monopoly in the market, as customers were unaware of Goprelto's existence and its FDA-approved status. Between June 2018 and September 2018, Genus sold only 544 bottles of Goprelto, while Lannett sold over 45,000 bottles of C-Topical, despite Goprelto's lower price[1].

Pricing and Profitability

The pricing strategy for Goprelto is influenced by its unique status as an FDA-approved product. Given its niche market and the lack of generic competition, Goprelto can command a premium price. However, the high prices of such specialized drugs can also limit their market penetration, especially if there are unapproved but cheaper alternatives available, as seen with C-Topical[1][3].

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics of Goprelto. FDA approval is a stringent process, and maintaining compliance with FDA regulations is essential for the product's continued market presence. Any allegations of false advertising or non-compliance can lead to significant legal and financial repercussions, as evidenced by the lawsuit against Lannett[1].

Distribution and Supply Chain

The distribution and supply chain for Goprelto are crucial for its market success. Companies like First Databank, which provide pricing lists and compare drug products, play a significant role in how products are perceived and purchased by wholesalers and customers. The use of unique identifying codes (CFI numbers) by these companies can either facilitate or hinder competition, as seen in the case where different CFI numbers prevented price comparisons between Goprelto and C-Topical[1].

Market Growth and Projections

The controlled substance market, which includes products like Goprelto, is projected to grow at a CAGR of approximately 7% during the forecast period. This growth is driven by factors such as the high incidence of chronic pain among the geriatric population and the increasing need for effective pain management solutions. However, the market also faces challenges such as regulatory scrutiny and the potential for abuse and addiction associated with certain controlled substances[4].

Financial Performance

The financial performance of Goprelto is closely tied to its market share and pricing strategy. Despite its FDA approval and unique benefits, Goprelto's sales have been impacted by the competitive tactics of Lannett. However, as the legal landscape clarifies and awareness about Goprelto's approved status increases, the product is likely to gain more market traction. The financial trajectory of Goprelto will depend on its ability to educate customers about its advantages and to navigate the complex regulatory and competitive environment effectively.

Educational and Marketing Efforts

To improve its market position, Genus needs to invest in educational and marketing efforts. This includes campaigns to inform pharmacists, doctors, and hospital groups about the FDA-approved status of Goprelto and its unique benefits compared to unapproved alternatives. Such efforts can help in increasing market awareness and driving sales[1].

Legal and Regulatory Challenges

The legal and regulatory challenges faced by Goprelto are significant. The lawsuit against Lannett for false advertising and the involvement of companies like First Databank highlight the complexities of the pharmaceutical market. Genus must continue to navigate these challenges to ensure that Goprelto remains a viable and competitive product in the market[1].

Conclusion

Goprelto's market dynamics and financial trajectory are influenced by a combination of factors including FDA approval, competitive landscape, pricing strategy, regulatory environment, distribution and supply chain, market growth projections, financial performance, educational and marketing efforts, and legal and regulatory challenges. As the market continues to evolve, Genus must remain vigilant and proactive in addressing these factors to ensure the long-term success of Goprelto.

Key Takeaways

• FDA Approval: Goprelto's FDA approval is a critical factor in its market legitimacy and competitive advantage.
• Competitive Landscape: The competition with unapproved products like C-Topical significantly impacts Goprelto's market share.
• Pricing Strategy: Goprelto's pricing is influenced by its unique status and the lack of generic competition.
• Regulatory Environment: Compliance with FDA regulations is essential for maintaining market presence.
• Distribution and Supply Chain: The use of unique identifying codes can affect price comparisons and competition.
• Market Growth: The controlled substance market is projected to grow, driven by chronic pain management needs.
• Financial Performance: Goprelto's financial performance is tied to its market share and pricing strategy.
• Educational and Marketing Efforts: Investing in education and marketing is crucial for increasing market awareness.
• Legal and Regulatory Challenges: Navigating legal and regulatory challenges is essential for Goprelto's success.

FAQs

Q: What is Goprelto used for? Goprelto is used as a local anesthetic and vasoconstrictor, particularly in diagnostic and therapeutic procedures involving the nasal, oral, and laryngeal cavities.

Q: Is Goprelto FDA-approved? Yes, Goprelto is FDA-approved, which distinguishes it from unapproved competitors like C-Topical.

Q: How does the competition with C-Topical affect Goprelto's market share? The competition with C-Topical, which was falsely advertised as FDA-approved, has significantly impacted Goprelto's market share, leading to a monopoly for C-Topical in the market.

Q: What are the key challenges faced by Goprelto in the market? Goprelto faces challenges such as false advertising by competitors, regulatory scrutiny, and the need for educational and marketing efforts to increase market awareness.

Q: What is the projected growth rate of the controlled substance market? The controlled substance market, which includes products like Goprelto, is projected to grow at a CAGR of approximately 7% during the forecast period.

Sources

1. Tushnet, R. (2019, May 8). She don't lie, but the pharmaco might: cocaine false advertising case continues. Retrieved from https://tushnet.com/2019/05/08/she-dont-lie-but-the-pharmaco-might-cocaine-false-advertising-case-continues/
2. FDA. (2017, December 13). 209963Orig1s000 - accessdata.fda.gov. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209963Orig1s000MedR.pdf
3. Chandra, A., Stern, A. D. (2018, October 4). The Economics of Drug Development: Pricing and Innovation in a Changing Market. Retrieved from https://www.nber.org/reporter/2018number3/economics-drug-development-pricing-and-innovation-changing-market
4. Transparency Market Research. Controlled Substance Market | Global Industry Report, 2027. Retrieved from https://www.transparencymarketresearch.com/controlled-substances-market.html