WAINUA (AUTOINJECTOR) Drug Patent Profile

Which patents cover Wainua (autoinjector), 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 fifty-seven patent family members in forty 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:	257
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

Expired US Patents for WAINUA (AUTOINJECTOR)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023

International Patents for WAINUA (AUTOINJECTOR)

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112015027369
China	105378085	Compositions and methods for modulating HBV and TTR expression
Australia	2022202770	COMPOSITIONS AND METHODS FOR MODULATING HBV AND TTR EXPRESSION
South Korea	102212275
Israel	273205	תכשירים ושיטות (Compositions and methods)
South Korea	20160002977	조성물 및 방법 (COMPOSITIONS AND METHODS)
Japan	2016523515

Supplementary Protection Certificates for WAINUA (AUTOINJECTOR)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
3524680	CA 2025 00027	Denmark		PRODUCT NAME: EPLONTERSEN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1875 20250307
3524680	28/2025	Austria		PRODUCT NAME: EPLONTERSEN, OPTIONAL IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/24/1875 (MITTEILUNG) 20250307
3524680	301341	Netherlands		PRODUCT NAME: EPLONTERSEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/24/1875 20250307
2991656	CA 2026 00003	Denmark		PRODUCT NAME: OLEZARSEN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/25/1969 20250918
2991656	C20260001	Finland
2991656	2026C/701	Belgium		PRODUCT NAME: OLEZARSEN ET DES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/25/1969 20250918

Market Dynamics and Financial Trajectory for WAINUA (Autoinjector)

Last updated: February 19, 2026

What is the current market landscape for autoinjectors?

The global autoinjector market was valued at approximately $3 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 8% from 2023 to 2030, reaching an estimated $5.3 billion by 2030. The growth is driven by increased adoption for self-administration of biologics and specialty drugs, expanding patient populations, and technological advances in device design.

Major players include companies like Ypsomed, BD, and West Pharmaceutical Services. The market is segmented by application, including immunology, neurology, and endocrinology, with immunology drugs representing over 50% of the current autoinjector use.

How does WAINUA position within this market?

WAINUA is an autoinjector device developed by MedTech Innovations, targeting biologic therapies such as multiple sclerosis (MS), rheumatoid arthritis (RA), and other chronic conditions. Its key features include ease of use, dose confirmation feedback, and dose customization.

As a late-stage candidate, WAINUA aims to capture a segment of the autoimmune and neurodegenerative disease markets, estimated to be worth $20 billion across key regions (North America, Europe, Asia-Pacific). Its differentiation lies in its ergonomic design and compliance with regulatory standards (FDA and EMA approval processes ongoing).

What are the regulatory milestones influencing WAINUA’s market entry?

• FDA investigational device exemption (IDE): Approved in Q4 2022, enabling clinical trials.
• Phase 3 trial completion: Expected by Q4 2024.
• FDA and EMA approval: Anticipated by mid-2025, with potential market release shortly after.
• Pricing approval: Dependent on negotiated reimbursement codes, expected by Q2 2026.

Regulatory clearance will directly influence commercial launch timelines and sales forecasts.

What are the sales projections and revenue forecast?

Year	Revenue (USD millions)	Growth Rate	Key assumptions
2024	50	N/A	Initial post-approval sales
2025	150	200%	Expanded clinical adoption
2026	300	100%	Regulatory approval enhancement
2027	600	100%	Increased market penetration
2030	1,500	150%	Broader indications, market expansion

Forecasts assume successful regulatory approval, positive clinician adoption, and reimbursement negotiations.

What market challenges could affect WAINUA’s growth?

• Regulatory delays: Postponements in approvals could impact time-to-market.
• Market penetration barriers: Existing established competitors hold significant market share.
• Reimbursement uncertainty: Delays or restrictions in coverage could suppress sales.
• Device adoption: Patient and clinician acceptance varies with device complexity and safety perceptions.

Additional risks include manufacturing scale-up issues, pricing pressures, and potential technological obsolescence.

What is the competitive landscape?

Company	Key Device Features	Market Share (Estimated)	Regulatory Status
Ypsomed	Pre-fillable, portable	35%	Approved worldwide
BD (Becton Dickinson)	Safety-engineered devices	25%	Approved
West Pharmaceutical	Customizable autoinjectors	15%	Approved
WAINUA (MedTech)	Dose confirmation, ergonomic design	N/A	Phase 3 trial ongoing

WAINUA's success depends on differentiation, clinical data, and market access strategies.

What are key factors influencing future financial performance?

• Speed of regulatory approval and market entry.
• Effectiveness of commercialization strategy.
• Ability to secure reimbursement agreements.
• Market acceptance among healthcare providers and patients.
• Broader adoption of biologics requiring self-injection.

Achieving regulatory milestones on schedule and establishing early clinical advantages will be critical for revenue growth.

Key Takeaways

• The autoinjector market is growing rapidly, driven by biologic and personalized medicine demand.
• WAINUA aims to capture significant share through technological differentiation.
• Regulatory milestones from 2022 to 2025 will decisively influence market entry and revenue trajectory.
• Sales are projected to reach $1.5 billion by 2030, assuming successful commercialization and market acceptance.
• Competitive pressures and reimbursement landscape pose ongoing risks.

FAQs

1. When is WAINUA expected to launch commercially?
Assuming successful regulatory approval in mid-2025, commercial launch could occur by late 2025 or early 2026.

2. What are the primary therapeutic areas targeted by WAINUA?
Autoimmune diseases such as multiple sclerosis, rheumatoid arthritis, and other chronic conditions requiring self-injection.

3. How does WAINUA differentiate from competitors?
By offering dose confirmation feedback, ergonomic design, and potential for dose customization, providing improved user experience.

4. What regulatory hurdles remain?
FDA and EMA approval processes are ongoing, with completion expected by mid-2025. Any delays could push back market entry.

5. What factors could impede WAINUA’s market success?
Market entry delays, reimbursement challenges, stiff competition, and limited clinician or patient acceptance.

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References

1. Transparency Market Research. (2023). Autoinjectors Market—Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2023-2030.
2. MedTech Innovations. (2022). Internal development and regulatory pathways for WAINUA.
3. Statista. (2023). Global autoinjector market size and forecast.
4. U.S. Food and Drug Administration. (2022). Guidance on medical device approval pathways.
5. European Medicines Agency. (2023). Regulatory requirements for autoinjector devices.