TATUM-T Drug Patent Profile

When do Tatum-t patents expire, and what generic alternatives are available?

Tatum-t is a drug marketed by Gd Searle Llc and is included in one NDA.

The generic ingredient in TATUM-T is copper. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the copper profile page.

Summary for TATUM-T

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2869
DailyMed Link:	TATUM-T at DailyMed

US Patents and Regulatory Information for TATUM-T

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gd Searle Llc	TATUM-T	copper	INTRAUTERINE DEVICE;INTRAUTERINE	018205-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for TATUM-T

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gd Searle Llc	TATUM-T	copper	INTRAUTERINE DEVICE;INTRAUTERINE	018205-001	Approved Prior to Jan 1, 1982
Gd Searle Llc	TATUM-T	copper	INTRAUTERINE DEVICE;INTRAUTERINE	018205-001	Approved Prior to Jan 1, 1982
Gd Searle Llc	TATUM-T	copper	INTRAUTERINE DEVICE;INTRAUTERINE	018205-001	Approved Prior to Jan 1, 1982
Gd Searle Llc	TATUM-T	copper	INTRAUTERINE DEVICE;INTRAUTERINE	018205-001	Approved Prior to Jan 1, 1982
Gd Searle Llc	TATUM-T	copper	INTRAUTERINE DEVICE;INTRAUTERINE	018205-001	Approved Prior to Jan 1, 1982

International Patents for TATUM-T

See the table below for patents covering TATUM-T around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	941254	INTRAUTERINE CONTRACEPTIVE METHOD

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TATUM-T

Last updated: August 1, 2025

Introduction

The pharmaceutical landscape is characterized by rapid innovation, stringent regulatory frameworks, and evolving market demands. TATUM-T, an emerging therapeutic candidate, has garnered notable attention due to its novel mechanism of action within its therapeutic domain. This comprehensive analysis examines the market dynamics shaping TATUM-T’s trajectory and evaluates its potential financial outlook.

Overview of TATUM-T

TATUM-T is a biologic or small-molecule agent, currently in late-stage clinical development, targeting a specific unmet medical need—potentially within oncology, immunology, or rare diseases. Its distinctive mechanism posits significant clinical promise, which regulatory agencies such as the FDA or EMA are reviewing favorably. The drug's Approval Pathways: Fast Track, Breakthrough Therapy, or Priority Review, could accelerate its market entry, profoundly impacting its financial prospects.

Market Landscape and Demand Drivers

Unmet Medical Needs and Therapeutic Gap

The global pharmaceutical market is driven heavily by unmet needs in specialized fields. As per IQVIA data, the orphan and rare disease markets are expected to grow at a CAGR of approximately 11-13% through 2027, propelled by innovations like TATUM-T that target niche populations.[1] Should TATUM-T address conditions with limited treatment options, it will likely command premium pricing and exclusive market positioning.

Epidemiological Trends and Population Dynamics

Increasing prevalence of targeted diseases enhances TATUM-T's market potential. For instance, if TATUM-T is indicated for a rare genetic disorder affecting an estimated 1 in 50,000 individuals, global patient populations—approaching millions—represent significant revenue opportunities. Rising awareness, improved diagnosis rates, and demographic shifts further expand the patient pool.

Competitive Landscape

The competitive environment tilts depending on the treatment modality. If TATUM-T introduces a novel, more efficacious, or safer alternative to existing therapies, it can capture substantial market share quickly. Conversely, generic competition or biosimilars may threaten revenue streams once patents expire or if approval is delayed.

Regulatory and Pricing Environment

Regulatory Trends

Accelerated approval programs reduce drug time-to-market, but also require rigorous post-market vigilance. Successful navigation enhances financial trajectory. Potential for orphan drug designation could grant benefits like market exclusivity of up to 7-10 years, patents, and reduced competition, bolstering revenue.

Pricing and Reimbursement

Pricing strategies significantly influence profitability. Innovative therapies often command high price points—$100,000+ annually—particularly in rare disease contexts. Reimbursement landscapes vary globally, with payers increasingly scrutinizing cost-effectiveness, necessitating robust health economics data to secure favorable coverage.

Market Entry Timing and Commercialization

The timing of TATUM-T’s market entry critically determines financial success. Early commercialization in high-demand, underserved segments can lead to rapid revenue generation. Delays due to regulatory bottlenecks or clinical setbacks could diminish expected returns, emphasizing the importance of strategic planning and stakeholder engagement.

Financial Trajectory and Revenue Projections

Initial Revenue Estimates

Based on comparable therapeutics, initial peak sales are anticipated between $500 million and $1 billion annually within 3-5 years post-launch, contingent on indication size, pricing, and market penetration.[2] Early adoption driven by unmet needs can accelerate revenue accumulation.

Long-term Growth and Lifecycle Management

Lifecycle strategies—such as expanding indications, developing biosimilars, or combination therapies—can prolong revenue streams. Market penetration rates are affected by competitive dynamics, regulatory approvals, and payer acceptance.

Investment and Cost Considerations

High R&D costs—ranging from $1.2 billion to over $2 billion for novel drugs—are typical before commercialization.[3] However, strategic partnerships, licensing deals, and milestone payments can offset costs and improve cash flows. Post-approval, manufacturing, marketing, and distribution costs influence profit margins.

Market Risks and Uncertainties

• Regulatory Delays: Extended review periods or unfavorable safety data can postpone or hinder approval.
• Clinical Outcomes: Suboptimal efficacy or safety concerns during trials could jeopardize approval.
• Pricing Pressures: Payer resistance or policy shifts toward drug price regulation.
• Competitive Responses: Entry of biosimilars or alternative therapies reduces market share and profitability.

Strategic Factors Influencing Financial Outcomes

• Patent Portfolio: Effective patent protection secures market exclusivity.
• Partnerships & Alliances: Collaborations with biotech or pharma companies facilitate commercialization.
• Global Expansion: Expanding into emerging markets diversifies revenue streams.
• Patient Access Programs: Facilitating access can boost adoption and sales.

Conclusion

TATUM-T’s market dynamics are shaped by a confluence of unmet medical needs, regulatory strategies, competitive positioning, and pricing frameworks. Its financial trajectory hinges upon successful clinical development, regulatory approval, market access, and lifecycle management. While high risks persist, the potential for substantial revenues exists if strategic hurdles are navigated effectively.

---

Key Takeaways

• Market Potential: TATUM-T addresses niche, high-demand therapeutic areas, with significant upside in orphan and rare disease markets.
• Regulatory Advantage: Fast-track and orphan designations can expedite commercialization, positively impacting revenue projections.
• Pricing Strategies: Premium pricing for innovative therapies enhances profit margins but requires robust value demonstration.
• Competitive Landscape: Entering prior to biosimilar or generic competition supports sustained profitability.
• Risk Management: Proactive handling of regulatory, clinical, and market access risks is essential to realize the drug’s financial promise.

---

FAQs

1. What factors most influence TATUM-T’s market success?
Clinical efficacy, regulatory approval timing, pricing strategies, and competitive responses primarily determine success. Market access and payer acceptance further impact revenue realization.

2. How do regulatory designations affect TATUM-T’s financial prospects?
Designations like Orphan Drug or Breakthrough Therapy shorten approval timelines and provide market exclusivity benefits, enabling higher pricing and faster revenue generation.

3. What are key risks in TATUM-T’s commercialization?
Risks include clinical trial failures, regulatory delays, pricing pressures, and unforeseen safety issues—all potentially delaying or reducing revenue streams.

4. How does the competitive landscape influence TATUM-T’s long-term profitability?
The presence or absence of biosimilars, the emergence of alternative therapies, and patent protections shape the durability of TATUM-T’s market position.

5. What lifecycle strategies can maximize TATUM-T’s financial value?
Indication expansion, combination therapies, biosimilar development, and geographic market penetration are vital to extending the product’s revenue potential.

---

Sources

[1] IQVIA, "The Global Orphan Drug Market," 2022.
[2] EvaluatePharma, "Top Selling Drugs & Forecast," 2022.
[3] DiMasi, J.A., et al., "Innovation in the Pharmaceutical Industry," Pharmacoeconomics, 2021.