WAINUA (AUTOINJECTOR) Drug Patent Profile

When do Wainua (autoinjector) patents expire, and what generic alternatives are available?

Wainua (autoinjector) is a drug marketed by Astrazeneca Ab and is included in one NDA. There are four patents protecting this drug.

This drug has two hundred and thirty-four patent family members in thirty-five countries.

The generic ingredient in WAINUA (AUTOINJECTOR) is eplontersen sodium. One supplier is listed for this compound. Additional details are available on the eplontersen sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Wainua (autoinjector)

Wainua (autoinjector) will be eligible for patent challenges on December 21, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

Indicators of Generic Entry

Summary for WAINUA (AUTOINJECTOR)

International Patents:	234
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	WAINUA (AUTOINJECTOR) at DailyMed

US Patents and Regulatory Information for WAINUA (AUTOINJECTOR)

WAINUA (AUTOINJECTOR) is protected by four US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes	10,683,499		Y	Y
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes	8,101,743		Y	Y
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes	9,127,276			Y
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes	9,181,549			Y
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes

International Patents for WAINUA (AUTOINJECTOR)

See the table below for patents covering WAINUA (AUTOINJECTOR) around the world.

Country	Patent Number	Title	Estimated Expiration
Malaysia	198359	COMPOSITIONS AND METHODS FOR MODULATING HBV AND TTR EXPRESSION
China	114058617
European Patent Office	2991661
Canada	2921162	COMPOSES ANTISENS CONJUGUES ET LEUR UTILISATION (CONJUGATED ANTISENSE COMPOUNDS AND THEIR USE)
China	110066795
Israel	242125	תרכובת המכילה קבוצת צימוד ואוליגונוקלאוטיד מותאם המורכב מ-12 עד 30 נוקלאוזידים משורשרים ושימוש בה לטיפול במחלת קשורה ל-hbv (Compound comprising conjugate group and modified oligonucleotide consisting of 12 to 30 linked nucleosides and use thereof for treating a hbv-related disease)
Japan	2021107408	ＨＢＶおよびＴＴＲ発現を調節するための組成物および方法 (COMPOSITIONS AND METHODS FOR MODULATING HBV AND TTR EXPRESSION)

WAINUA (AUTOINJECTOR) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for WAINUA (Autoinjector)

Introduction

WAINUA, formerly known as eplontersen, is a groundbreaking drug developed by Ionis Pharmaceuticals and AstraZeneca for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis (ATTRv-PN). Here, we delve into the market dynamics and financial trajectory of this significant therapeutic advancement.

FDA Approval and Regulatory Milestones

In December 2023, WAINUA received FDA approval in the U.S., marking a crucial milestone for patients with ATTRv-PN. This approval makes WAINUA the only medicine for this condition that can be self-administered via an auto-injector[3][5].

Market Positioning

WAINUA is uniquely positioned to address the unmet medical needs of ATTRv-PN patients. Its self-administered auto-injector format enhances patient convenience and compliance, setting it apart from other treatments. The drug's approval in the U.S. and subsequent approval in Canada further expand its market reach[3][4].

Launch and Sales Performance

The launch of WAINUA has been progressing well. In the first quarter of 2024, WAINUA generated $1 million in sales, resulting in $5 million in royalty revenue for Ionis. By the second quarter, sales had increased to $16 million, with royalty revenue of $4 million. These figures indicate a strong start for the drug in the market[1][2].

Revenue Projections

Visible Alpha consensus estimates suggest that WAINUA will generate $20 million in revenue in 2024. More significantly, peak sales are projected to reach $1.8 billion by 2039. WAINUA is expected to account for 3.1% of Ionis’s total revenue in 2024, increasing to 23.3% by 2030[4].

Financial Impact on Ionis Pharmaceuticals

The launch of WAINUA has contributed to Ionis's revenue growth. In the first quarter of 2024, Ionis reported total revenue that included a new source of royalty revenue from WAINUA. The second quarter saw a 20% year-over-year revenue increase, partly driven by WAINUA's sales and the amortization of upfront payments from new collaborations with Roche and Novartis[1][2].

Operating Expenses and Investments

Ionis has increased its operating expenses in both the first and second quarters of 2024, primarily due to strategic investments in the launch and commercialization of WAINUA, as well as other late-stage development programs like olezarsen and donidalorsen. These investments are crucial for driving future revenue growth and expanding the company's pipeline[1][2].

Cash Position and Financial Guidance

As of March 31, 2024, Ionis had $2.2 billion in cash and short-term investments, which enables continued investments in its pipeline and commercial activities. Despite a decrease in cash position to $2.1 billion by the end of the second quarter, Ionis reaffirmed its 2024 financial guidance, indicating confidence in its financial trajectory[1][2].

Competitive Landscape

WAINUA's approval and successful launch position it as a leader in the treatment of ATTRv-PN. With no other self-administered treatments available for this condition, WAINUA enjoys a competitive advantage. The drug's efficacy and convenience are expected to drive market share and patient preference[3][5].

Patient Impact and Clinical Significance

"The FDA approval of WAINUA marks an important milestone for people living with hereditary transthyretin-mediated amyloid polyneuropathy, who will now have an effective, well-tolerated treatment that can be self-administered via auto-injector to combat this devastating disease," said Brett P. Monia, Ph.D., CEO of Ionis Pharmaceuticals. This underscores the significant clinical benefit WAINUA offers to patients[3][5].

Future Regulatory Approvals

A decision by the European Medicines Agency (EMA) is expected in the second half of 2024, which could further expand WAINUA's market reach. The drug's recent approval in Canada also highlights its growing global presence[4].

Conclusion

WAINUA's market dynamics and financial trajectory are highly promising. With its unique self-administered format, strong sales performance, and significant revenue projections, WAINUA is poised to make a profound impact on the treatment of ATTRv-PN. Ionis Pharmaceuticals' strategic investments and robust financial position support the continued success of WAINUA and the company's broader pipeline.

Key Takeaways

• FDA Approval: WAINUA received FDA approval in December 2023 for the treatment of ATTRv-PN.
• Sales Performance: Generated $1 million in sales in Q1 2024 and $16 million in Q2 2024.
• Revenue Projections: Expected to generate $20 million in revenue in 2024, with peak sales of $1.8 billion by 2039.
• Financial Impact: Contributed to Ionis's revenue growth and increased operating expenses due to launch and commercialization efforts.
• Competitive Advantage: Unique self-administered auto-injector format with no other similar treatments available.
• Patient Impact: Offers effective and well-tolerated treatment for ATTRv-PN patients.

FAQs

Q: What is WAINUA used for? A: WAINUA is used for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis (ATTRv-PN).

Q: Who developed WAINUA? A: WAINUA was developed by Ionis Pharmaceuticals and AstraZeneca.

Q: How is WAINUA administered? A: WAINUA is self-administered via an auto-injector.

Q: What are the revenue projections for WAINUA? A: WAINUA is expected to generate $20 million in revenue in 2024, with peak sales projected at $1.8 billion by 2039.

Q: Has WAINUA been approved in other countries besides the U.S.? A: Yes, WAINUA has been approved in Canada, and a decision by the European Medicines Agency (EMA) is expected in the second half of 2024.

Sources

1. Ionis reports first quarter 2024 financial results | IONS Stock News
2. Ionis reports second quarter 2024 financial results | IONS Stock News
3. AstraZeneca's Wainua receives FDA approval in the US
4. Ionis Pharmaceuticals' WAINUA Approval Signals Promising Revenue Growth
5. WAINUA™ (eplontersen) granted regulatory approval in the U.S. for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis