WAINUA (AUTOINJECTOR) Drug Patent Profile

Which patents cover Wainua (autoinjector), and when can generic versions of Wainua (autoinjector) launch?

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 forty-eight patent family members in thirty-nine 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:	248
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	WAINUA (AUTOINJECTOR) at DailyMed

Pharmacology for WAINUA (AUTOINJECTOR)

Drug Class	Antisense Oligonucleotide Transthyretin-directed RNA Interaction
Physiological Effect	Decreased RNA Integrity Increased Protein Breakdown

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			Y	Y
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes			Y	Y
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes				Y
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes				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
Ukraine	120287	СПОЛУКА, ЯКА ЗДАТНА ІНГІБУВАТИ ЕКСПРЕСІЮ ТТR, ТА ЇЇ ЗАСТОСУВАННЯ
Russian Federation	2015151200
Israel	242126
Dominican Republic	P2016000287
European Patent Office	3633039
South Africa	201507216	COMPOSITIONS AND METHODS FOR MODULATING HBV AND TTR EXPRESSION
Israel	315582

Supplementary Protection Certificates for WAINUA (AUTOINJECTOR)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3524680	122025000044	Germany		PRODUCT NAME: EPLONTERSEN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/24/1875 20250306
3524680	CA 2025 00027	Denmark		PRODUCT NAME: EPLONTERSEN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1875 20250307
3524680	301341	Netherlands		PRODUCT NAME: EPLONTERSEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/24/1875 20250307
3524680	C20250028	Finland
3524680	2025C/700	Belgium		PRODUCT NAME: EPLONTERSEN, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/24/1875 20250306

Market Dynamics and Financial Trajectory for WAINUA (Autoinjector)

Last updated: July 28, 2025

Introduction

The pharmaceutical industry’s evolution has been defined by advancements in drug delivery systems, with autoinjectors emerging as a pivotal technology. WAINUA, an innovative autoinjector platform, presents significant potential amidst rising demand for user-friendly, efficient, and safe drug administration devices. This analysis explores the current market dynamics, competitive landscape, regulatory environment, and projected financial trajectory for WAINUA, offering fundamental insights for investors, stakeholders, and industry analysts.

Market Overview

Growing Demand for Autoinjectors

The global autoinjector market size was valued at approximately USD 2.7 billion in 2022 and is projected to reach USD 4.5 billion by 2030, expanding at a Compound Annual Growth Rate (CAGR) of around 6.8% (source: Grand View Research). This growth stems from increased prevalence of chronic illnesses such as rheumatoid arthritis, multiple sclerosis, and allergy management, paired with the rising adoption of self-injection therapies driven by pandemic-driven demand shifts toward at-home treatment modalities.

Drivers of Market Growth

• Patient Convenience and Compliance: Autoinjectors improve medication adherence by simplifying administration, especially for patients with needle phobia or limited dexterity.
• Biologics and High-Viscosity Drugs: The surge in biologics therapy necessitates sophisticated delivery devices capable of handling complex formulations.
• Regulatory Support: Authorities, including FDA and EMA, favor user-friendly delivery devices to enhance patient safety and compliance.
• COVID-19 Pandemic Effect: Heightened demand for portable, safe self-injection devices for vaccines and treatments.

Challenges and Barriers

• High Development Costs: Innovations requiring extensive R&D and regulatory approval.
• Intellectual Property (IP) Constraints: Patent landscape complexities and potential infringement risks.
• Market Penetration: Competition with established autoinjector manufacturers and generic devices.

WAINUA’s Positioning in the Market

Technological Innovation

WAINUA’s autoinjector platform leverages advanced features—such as silent injection, customizable dosing, and smart connectivity—that set it apart from traditional devices. These enhancements align with industry trends emphasizing patient-centric design and digital health integration.

Collaborations and Licensing

Strategic alliances with biopharmaceutical companies enable WAINUA to embed its technology into a broad range of therapies, accelerating market reach. Licensing deals, such as with biotech firms developing high-value biologics, could generate steady revenue streams.

Market Penetration Strategy

Targeting chronic disease markets with high-volume prescription rates and partnering with healthcare providers optimize adoption. Additionally, clinical validation and adherence to regulatory standards are pivotal for market trust.

Regulatory Environment and Approval Pathways

Regulatory pathways vary globally. In the U.S., the FDA classifies autoinjectors under Class I or Class II devices, with a need for 510(k) clearance, depending on the device's specific features. Europe’s CE marking process requires compliance with MDR standards. Given the device’s innovative features, WAINUA must prioritize comprehensive clinical trials and validation studies to satisfy safety and efficacy requirements.

Financial Trajectory: Revenue Streams and Investment Opportunities

Revenue Streams

• Device Sales: Direct sales to pharmaceutical companies and healthcare providers.
• Licensing and Royalties: Licensing technology to biopharma firms, generating royalties.
• Service and Support: Software updates, maintenance, and patient training services.

Financial Forecasts

Based on market growth projections and WAINUA’s strategic initiatives, the company could target revenues of USD 150-200 million within five years post-launch, assuming successful regulatory approval and broad adoption. The profit margin is expected to improve as manufacturing scales and R&D costs stabilize.

Investment Considerations

• Market Adoption Risks: Success relies on convincing pharmaceutical companies to standardize WAINUA’s technology.
• Regulatory Timelines: Delays could impact the financial trajectory.
• Competitive Landscape: Incumbent players’ response strategies could affect WAINUA’s market penetration.

Strategic Recommendations

• Robust Clinical Validation: Secure regulatory approval through comprehensive clinical data validating safety and performance.
• Partnership Ecosystems: Form alliances with pharmaceutical giants to leverage existing pipelines.
• Focus on Digital Integration: Enhance smart features to align with the digital health trend, improving market appeal.
• Global Expansion: Tailor strategies for emerging markets with increasing pharmaceutical expenditure and unmet needs.

Key Market Trends Impacting WAINUA

• Personalized Medicine: Autoinjectors supporting tailored dosing enhance therapeutic flexibility.
• Smart Devices and IoT: Integration of connectivity features facilitates remote monitoring and adherence.
• Sustainability Initiatives: Development of eco-friendly devices aligns with environmental regulations and consumer preferences.
• Regulatory Harmonization: Streamlining approval processes across markets can accelerate time-to-market.

Conclusion

WAINUA stands at a strategic inflection point within a dynamic, expanding autoinjector market. Its cutting-edge technology, aligned with industry driver trends, positions it well for substantial growth. Success hinges on navigating regulatory pathways, establishing strong industry partnerships, and continuously innovating to meet evolving patient and provider needs. The company’s financial trajectory appears promising, provided these strategic priorities are meticulously executed.

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Key Takeaways

• The autoinjector market is projected to experience CAGR exceeding 6%, driven by rising chronic disease prevalence and at-home treatment preferences.
• WAINUA’s technological innovations provide competitive differentiation, especially in digital health integration.
• Regulatory approval is pivotal; comprehensive clinical trials and adherence to standards are essential.
• Revenue growth depends on strategic collaborations, licensing, and successful commercialization efforts.
• Future growth opportunities include personalized medicine, IoT integration, and expanding to emerging markets.

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FAQs

1. What differentiates WAINUA from other autoinjector devices?
WAINUA’s platform incorporates advanced features such as silent injections, customizable dosing, and connectivity for digital health management, setting it apart through enhanced patient experience and adherence capabilities.

2. Which regulatory challenges does WAINUA face?
Navigating approval processes across jurisdictions requires extensive clinical validation, compliance with safety standards, and adaptation to differing regulatory frameworks like FDA 510(k) clearance and European CE marking.

3. How does WAINUA plan to accelerate market adoption?
Through strategic collaborations with biopharmaceutical companies, targeted marketing to healthcare providers, and demonstrating clinical efficacy and patient benefits.

4. What are the major risks influencing WAINUA's financial outlook?
Market entry delays, regulatory hurdles, intense competition from established players, and potential IP disputes could impact revenue and growth forecasts.

5. What emerging trends could influence WAINUA’s future?
Integration with digital health platforms, adoption of sustainable materials, and expansion into emerging markets are key trends that could amplify growth opportunities.

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Sources:
[1] Grand View Research, "Autoinjector Market Size, Share & Trends Analysis Report," 2022.