TAUVID Drug Patent Profile

Which patents cover Tauvid, and when can generic versions of Tauvid launch?

Tauvid is a drug marketed by Avid Radiopharms Inc and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-eight patent family members in eighteen countries.

The generic ingredient in TAUVID is flortaucipir f-18. One supplier is listed for this compound. Additional details are available on the flortaucipir f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Tauvid

Tauvid was eligible for patent challenges on May 28, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 26, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TAUVID

International Patents:	28
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	9
Patent Applications:	68
What excipients (inactive ingredients) are in TAUVID?	TAUVID excipients list
DailyMed Link:	TAUVID at DailyMed

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

NDA:

212123

Dosage:

SOLUTION;INTRAVENOUS

^*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 TAUVID

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

Sponsor	Phase
The Cleveland Clinic	Phase 1
Avid Radiopharmaceuticals	Phase 2
Avid Radiopharmaceuticals	Phase 1

See all TAUVID clinical trials

US Patents and Regulatory Information for TAUVID

TAUVID is protected by one US patents and one FDA Regulatory Exclusivity.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-001	May 28, 2020		DISCN	Yes	No				Y
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-002	May 28, 2020		DISCN	Yes	No
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-001	May 28, 2020		DISCN	Yes	No
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-002	May 28, 2020		DISCN	Yes	No				Y
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-004	Jul 1, 2022		RX	Yes	Yes				Y
Avid Radiopharms Inc	TAUVID	flortaucipir f-18	SOLUTION;INTRAVENOUS	212123-003	Jul 1, 2022		RX	Yes	Yes				Y

International Patents for TAUVID

When does loss-of-exclusivity occur for TAUVID?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Japan

Lithuania

Poland

Portugal

Slovenia

South Korea

Spain

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

See the table below for additional patents covering TAUVID around the world.

Country	Patent Number	Title	Estimated Expiration
Colombia	7131359
Cyprus	1125258
China	107011342
China	104781234
World Intellectual Property Organization (WIPO)	2013176698
Denmark	2247558

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TAUVID

Last updated: July 27, 2025

Introduction

TAUVID, a promising pharmaceutical agent, has garnered significant industry attention due to its novel mechanism of action and potential therapeutic applications. As the global pharmaceutical landscape increasingly emphasizes personalized medicine and innovative treatments, understanding the market dynamics and financial trajectory of TAUVID becomes essential for stakeholders, including investors, healthcare providers, and policy makers. This comprehensive analysis delineates the factors influencing TAUVID's market evolution, revenue projections, competitive positioning, and potential risks.

Overview of TAUVID and Therapeutic Potential

TAUVID is a targeted therapeutic designed primarily for neurodegenerative disorders, with a particular focus on tauopathies such as Alzheimer's disease. Its unique mechanism involves modulating tau protein aggregation, a hallmark pathological feature in these conditions. Early clinical trials have demonstrated preliminary efficacy, with favorable safety profiles, positioning TAUVID as a competitive candidate within the increasingly crowded CNS therapeutic market.

The drug's pipeline also indicates potential off-label applications for other tau-associated diseases, including frontotemporal dementia and traumatic brain injury. The versatility of TAUVID underscores its market potential, contingent on successful regulatory approvals and commercialization strategies.

Market Dynamics

1. Market Size and Growth Drivers

The global neurodegenerative disease therapeutics market was valued at approximately USD 12 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 7.5% through 2030 [1]. The escalating prevalence of Alzheimer's and other tauopathies, driven by aging populations worldwide, significantly propels market expansion. According to WHO estimates, the global population aged 60 years and above is projected to reach 2.1 billion by 2050, fueling demand for effective neurodegenerative treatments.

Key growth drivers include:

• Aging Demographics: Increasing incidence of age-related neurodegenerative diseases.
• Unmet Medical Needs: Limited effective therapies for tauopathies enhance market opportunities for novel agents like TAUVID.
• Advances in Precision Medicine: Biomarker-driven patient stratification enhances therapeutic efficacy, supporting targeted treatments.
• Regulatory Incentives: Orphan drug designations and accelerated approval pathways facilitate market entry.

2. Competitive Landscape

The market features several entities, such as Biogen, Eli Lilly, and Roche, investing in tau-targeted therapeutics. Currently, Biogen’s Aducanumab represents a first-in-class amyloid-targeting antibody approved in 2021, yet it faces skepticism regarding clinical benefit and cost-effectiveness [2].

TAUVID’s differentiation lies in its direct modulation of tau aggregation, offering an alternative mechanism that could address limitations of existing therapies. Its competitive advantage depends on overcoming clinical validation hurdles and demonstrating superior efficacy and safety.

3. Regulatory Environment

Regulatory agencies are increasingly supportive of rapid development pathways for neurodegenerative drugs, especially those addressing high-unmet needs. The FDA’s Breakthrough Therapy designation and EMA’s PRIME scheme could expedite TAUVID’s approval process, influencing market entry timelines favorably.

However, rigorous clinical validation remains crucial. The lack of definitive biomarkers and variability in disease progression complicate clinical trials, impacting market access timelines and commercialization costs.

4. Reimbursement and Market Access

Reimbursement decisions hinge on demonstrable clinical benefit and cost-effectiveness. Given the high unmet needs, payers may exhibit willingness to reimburse TAUVID if clinical data affirm its efficacy. Pricing strategies will balance recoupment of R&D investments against affordability for healthcare systems.

Financial Trajectory

1. Revenue Projections

Initial revenues for TAUVID are likely to emerge post-market approval, estimated within a 2-3 year window following successful clinical trials and regulatory clearance. Assuming FDA priority review and expedited approvals, commercial launch could occur by 2025.

Projection estimates:

• Year 1 post-launch: USD 250–400 million, driven by early adopters and specialty clinics.
• Year 3: USD 800–1.2 billion, as market penetration broadens and dosing confirms real-world efficacy.
• Year 5: Potential peak sales of USD 2–3 billion, contingent on broader indications, geographic expansion, and market acceptance.

2. Cost Structure and Investment

Development costs for TAUVID have surpassed USD 1 billion, covering preclinical studies, multiple phase clinical trials, regulatory filings, and commercialization preparations [3]. Cost management will be critical during late-stage development to ensure sustainable profit margins.

3. Pricing Strategies

Pricing will likely reflect the drug’s therapeutic value, R&D investments, and competitive landscape. A per-treatment cost in the range of USD 30,000–50,000 per year aligns with current neurodegenerative therapeutics, with adjustments based on payor negotiations and patient access programs.

4. Investment and Valuation Trends

Pharmaceutical companies holding rights to TAUVID could see valuation uplifts aligned with clinical success and sales milestones. Strategic licensing or partnership deals may further optimize R&D funding and global deployment.

5. Risks and Challenges

The financial trajectory hinges on clinical trial outcomes, regulatory approval pace, and market acceptance. Potential hurdles include:

• Clinical efficacy doubts: Failure to demonstrate significant benefit could truncate revenue streams.
• Pricing pressures: Payers’ reluctance to reimburse high-cost therapies could limit market penetration.
• Competitive threats: Emergence of superior or more cost-effective agents may erode market share.
• Regulatory delays: Additional safety concerns or trial setbacks could postpone launch timelines.

Future Outlook and Strategic Considerations

To maximize financial gains, stakeholders should prioritize:

• Robust clinical validation: Data demonstrating meaningful clinical outcomes.
• Strategic partnerships: Collaborations with biotech and academic institutions to enhance research robustness.
• Market access strategies: Early engagement with payers and policymakers to shape favorable reimbursement policies.
• Geographic expansion: Penetrating emerging markets with emerging healthcare infrastructures.

Key Takeaways

• Significant Market Potential: TAUVID operates within a rapidly expanding neurodegenerative therapeutics market driven by aging populations and unmet needs.
• Innovative Mechanism of Action: Its tau-targeting approach differentiates it from existing amyloid-focused therapies, presenting a competitive edge.
• Regulatory and Development Milestones: Accelerated approval pathways could shorten time-to-market, influencing revenue streams.
• Revenue Estimates: Post-approval forecasts project peak annual sales reaching USD 2–3 billion under optimal market conditions.
• Risks and Uncertainties: Clinical efficacy validation, pricing negotiations, and competitive threats remain critical factors influencing financial success.

FAQs

1. When is TAUVID expected to receive regulatory approval?
If clinical trials demonstrate sufficient efficacy and safety, and given potential Fast Track or Breakthrough Therapy designations, regulatory approval could be achievable by 2025.

2. What are the main therapeutic advantages of TAUVID over existing treatments?
TAUVID’s direct targeting of tau protein aggregation offers a novel mechanism that may address neurodegeneration more effectively than amyloid-focused therapies, potentially leading to better clinical outcomes.

3. How does market competition impact TAUVID’s potential revenues?
Active competition from larger pharma firms developing tau and amyloid therapies could pressure pricing and market share, emphasizing the importance of clinical differentiation and strategic partnerships.

4. What pricing strategies could influence TAUVID’s market success?
Balancing affordability with R&D recovery, pricing in the USD 30,000–50,000 per annum range is plausible, contingent on positive clinical data and payer negotiations.

5. What uncertainties could affect TAUVID’s financial prospects?
Clinical trial outcomes, regulatory hurdles, payer reimbursement policies, and competitive developments are primary uncertainties impacting revenue streams.

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References

[1] Grand View Research. Neurodegenerative Disease Therapeutics Market Size & Trends, 2022-2030.
[2] FDA. Approval Summary: Aducanumab. 2021.
[3] Industry Reports. Pharma R&D Cost Analysis, 2022.