TRUDHESA Drug Patent Profile

When do Trudhesa patents expire, and what generic alternatives are available?

Trudhesa is a drug marketed by Impel Pharms and is included in one NDA. There are six patents protecting this drug.

This drug has sixty-four patent family members in sixteen countries.

The generic ingredient in TRUDHESA is dihydroergotamine mesylate. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Trudhesa

A generic version of TRUDHESA was approved as dihydroergotamine mesylate by PADAGIS US on April 28^th, 2003.

Summary for TRUDHESA

International Patents:	64
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Patent Applications:	1,302
Drug Prices:	Drug price information for TRUDHESA
What excipients (inactive ingredients) are in TRUDHESA?	TRUDHESA excipients list
DailyMed Link:	TRUDHESA at DailyMed

See drug prices for TRUDHESA

Pharmacology for TRUDHESA

Drug Class

Ergotamine Derivative

US Patents and Regulatory Information for TRUDHESA

TRUDHESA is protected by six US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impel Pharms	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes	11,185,497
Impel Pharms	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes
Impel Pharms	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes	9,550,036		Y
Impel Pharms	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes	9,919,117		Y
Impel Pharms	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes	10,940,278		Y

International Patents for TRUDHESA

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

Country	Patent Number	Title	Estimated Expiration
Canada	3111516	DISPOSITIF D'ADMINISTRATION DE MEDICAMENT PAR VOIE NASALE (NASAL DRUG DELIVERY DEVICE)
Japan	2020185475	直列形経鼻送達デバイス (IN-LINE NASAL DELIVERY DEVICE)
European Patent Office	3735244	ADMINISTRATION INTRANASALE DE DIHYDROERGOTAMINE PAR UN DISPOSITIF OLFACTIF DE PRÉCISION (INTRANASAL DELIVERY OF DIHYDROERGOTAMINE BY PRECISION OLFACTORY DEVICE)
Australia	2016256665	Nasal drug delivery device
Canada	2828884	DISPOSITIF D'ADMINISTRATION DE MEDICAMENT PAR VOIE NASALE (NASAL DRUG DELIVERY DEVICE)

TRUDHESA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trudhesa

Introduction

Trudhesa, developed by Impel Pharmaceuticals Inc., is a transformative therapy for acute migraine, specifically a dihydroergotamine mesylate nasal spray. Since its commercial launch in October 2021, Trudhesa has shown significant growth and market penetration. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Positioning of Trudhesa

Trudhesa has quickly established itself in the acute migraine market. By the end of 2022, it accounted for 4.3% of branded acute migraine prescriptions (nTRx) among prescribers, a notable achievement in its first full year of launch[1][2][4].

Prescription Growth

The prescription volume of Trudhesa has been robust. In 2022, the drug generated over 58,400 prescriptions, with a 19.4% increase in new prescriptions from Q3 to Q4 2022. This growth was further accelerated in Q1 2023, with new prescriptions increasing by 112% compared to Q1 2022, reaching over 18,500 prescriptions for the quarter[1][2].

Sales Force Expansion and Efficiency

A key factor in Trudhesa's success has been the expansion and optimization of Impel's sales force. In July 2022, the company increased its sales force by 50%, from 60 to 90 sales professionals. This expansion led to a 24% increase in new Trudhesa prescriptions from Q3 to Q4 2022 and an 18% increase from Q4 2022 to Q1 2023[1][2][4].

Reimbursement and Refill Rates

Reimbursement rates for Trudhesa have also seen significant improvement. By Q1 2023, the reimbursement rate for all shipments was 72%, up from 60% in Q4 2022. Additionally, refill rates have remained consistently high, averaging 62% since the launch and 63% at the end of 2022[2][4].

Financial Performance

Net Product Revenue

The financial performance of Trudhesa has been strong. For the full year 2022, net product revenue from Trudhesa sales was $12.7 million, a significant increase from $0.7 million in 2021. In Q4 2022, net product revenue was $5 million, a 62% increase from Q3 2022. For Q1 2023, the revenue was $4.4 million, a 149% increase from Q1 2022[1][2].

Research and Development (R&D) Expenses

R&D expenses have decreased as the company has shifted its focus from clinical trials to commercial operations. In 2022, R&D expenses were $11.5 million, down from $20.6 million in 2021. For Q1 2023, R&D expenses were $3 million, lower than the $3.7 million in Q1 2022 due to reduced personnel and program costs[1][2].

Selling, General and Administrative (SG&A) Expenses

SG&A expenses have increased to support the commercial launch and ongoing marketing efforts. For the full year 2022, SG&A expenses were $77.9 million, up from $50.9 million in 2021. In Q1 2023, SG&A expenses were $22 million, an increase from $19.8 million in Q1 2022[1][2].

Net Loss

Despite the revenue growth, Impel Pharmaceuticals has reported net losses. For the full year 2022, the net loss was $106.3 million, and for Q1 2023, it was $30.1 million. However, these losses are part of the company's investment in commercializing Trudhesa and expanding its market presence[1][2].

Cash Runway and Funding

As of March 31, 2023, Impel Pharmaceuticals had approximately $35.5 million in cash and cash equivalents. The company believes it has sufficient capital to fund operations into Q3 2023, allowing it to continue focusing on maximizing the commercial potential of Trudhesa[2].

Strategic Reprioritization

Impel Pharmaceuticals has undertaken a strategic reprioritization to focus more on the commercialization of Trudhesa. This involves streamlining clinical development expenses to allocate resources more efficiently towards the growing commercial opportunity of Trudhesa. This move is expected to help the company achieve its business objectives more effectively[4].

Market Growth Projections

For 2023, Impel Pharmaceuticals projects that Trudhesa will deliver prescriptions within the range of 80,000 to 110,000, indicating continued strong growth in the market. This projection is supported by the drug's current trajectory and the expanded sales force's efficiency[1][2].

Conclusion

Trudhesa has demonstrated a strong market presence and financial growth since its launch. The expansion of the sales force, improvements in reimbursement rates, and high refill rates have all contributed to its success. While the company continues to report net losses, these are part of its strategic investment in commercializing Trudhesa. With a solid cash runway and a focus on maximizing the commercial potential of Trudhesa, Impel Pharmaceuticals is well-positioned to continue its growth in the acute migraine market.

Key Takeaways

• Strong Prescription Growth: Trudhesa generated over 58,400 prescriptions in 2022 and saw a 112% increase in Q1 2023 compared to Q1 2022.
• Sales Force Efficiency: The expansion of the sales force in July 2022 significantly increased new prescriptions and improved sales efficiency.
• Financial Performance: Net product revenue for Trudhesa was $12.7 million in 2022 and $4.4 million in Q1 2023, with a 149% increase from Q1 2022.
• Reimbursement and Refill Rates: Reimbursement rates improved to 72% in Q1 2023, and refill rates remained high at 62%.
• Strategic Reprioritization: Impel Pharmaceuticals is focusing resources on maximizing Trudhesa's commercial potential by streamlining clinical development expenses.

FAQs

Q: What is Trudhesa, and how does it work? A: Trudhesa is a dihydroergotamine mesylate nasal spray used for the acute treatment of migraine. It works by delivering the active ingredient directly through the nasal route, providing quick relief from migraine symptoms.

Q: How has Trudhesa performed in terms of prescriptions since its launch? A: Trudhesa generated over 58,400 prescriptions in 2022 and saw a significant increase in Q1 2023, with prescriptions up 112% compared to Q1 2022.

Q: What role has the sales force expansion played in Trudhesa's success? A: The expansion of the sales force in July 2022 increased new prescriptions by 24% from Q3 to Q4 2022 and by 18% from Q4 2022 to Q1 2023, significantly contributing to Trudhesa's growth.

Q: How have reimbursement rates and refill rates impacted Trudhesa's performance? A: Reimbursement rates improved to 72% in Q1 2023, and refill rates have remained consistently high at 62%, indicating strong patient adherence and market acceptance.

Q: What are Impel Pharmaceuticals' financial projections for Trudhesa in 2023? A: Impel Pharmaceuticals projects that Trudhesa will deliver prescriptions within the range of 80,000 to 110,000 in 2023, indicating continued strong growth.

Sources

1. Impel Pharmaceuticals Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update. Globenewswire.
2. Impel Pharmaceuticals Announces First Quarter 2023 Financial Results and Provides Business Update. Biospace.
3. Impel Pharmaceuticals Inc. (IMPL) BCG Matrix Analysis. dcf.fm.
4. Impel Pharmaceuticals Announces Strategic Reprioritization and Continues Focus on Maximizing Trudhesa Commercial Opportunity. Biospace.
5. Form 8-K IMPEL NEUROPHARMA INC For: Jan 18. StreetInsider.