TESLASCAN Drug Patent Profile

When do Teslascan patents expire, and when can generic versions of Teslascan launch?

Teslascan is a drug marketed by Ic Targets and is included in one NDA.

The generic ingredient in TESLASCAN is mangafodipir trisodium. Additional details are available on the mangafodipir trisodium profile page.

Summary for TESLASCAN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	1
DailyMed Link:	TESLASCAN at DailyMed

Recent Clinical Trials for TESLASCAN

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

Sponsor	Phase
Egetis Therapeutics	Phase 2
PledPharma AB	Phase 2

See all TESLASCAN clinical trials

US Patents and Regulatory Information for TESLASCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ic Targets	TESLASCAN	mangafodipir trisodium	INJECTABLE;INJECTION	020652-001	Nov 26, 1997		DISCN	No	No

Expired US Patents for TESLASCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ic Targets	TESLASCAN	mangafodipir trisodium	INJECTABLE;INJECTION	020652-001	Nov 26, 1997	4,647,447
Ic Targets	TESLASCAN	mangafodipir trisodium	INJECTABLE;INJECTION	020652-001	Nov 26, 1997	4,933,456
Ic Targets	TESLASCAN	mangafodipir trisodium	INJECTABLE;INJECTION	020652-001	Nov 26, 1997	5,223,243
Ic Targets	TESLASCAN	mangafodipir trisodium	INJECTABLE;INJECTION	020652-001	Nov 26, 1997	5,091,169
Ic Targets	TESLASCAN	mangafodipir trisodium	INJECTABLE;INJECTION	020652-001	Nov 26, 1997	4,992,554

International Patents for TESLASCAN

See the table below for patents covering TESLASCAN around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2137612
Germany	3270097
Singapore	83789
Ireland	840126
Argentina	246956	COMPUESTO QUELANTE, UN INTERMEDIARIO PARA PREPARAR EL MISMO, Y UN PROCEDIMIENTO PARA PREPARAR UNA COMPOSICION DE MEDIO DE CONTRASTE. (DIPYRIDOXYL PHOSPHATE NUCLEAR MAGNETIC RESONANCE IMAGERY CONTRAST AGENTS)
United Kingdom	2169599	PHYSIOLOGICALLY TOLERABLE METAL COMPLEX SALTS FOR USE IN DIAGNOSIS
Germany	19775088

Supplementary Protection Certificates for TESLASCAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0071564	SPC/GB93/060	United Kingdom
0290047	97C0108	Belgium		PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
0290047	67/1997	Austria		PRODUCT NAME: MANGAFODIPIR; REGISTRATION NO/DATE: SG(97)D/3940 19970522
0290047	C00290047/01	Switzerland		FORMER REPRESENTANTIVE: A. BRAUN, BRAUN, HERITIER, ESCHMANN AG PATENTANWAELTE, CH
0290047	SPC/GB97/078	United Kingdom		PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522

Market Dynamics and Financial Trajectory for TESLASCAN

Last updated: February 20, 2026

What is TESLASCAN and its current market position?

TESLASCAN (generic name: teplizumab) is an immunomodulatory drug developed by Provention Bio, designed to delay or prevent the progression of type 1 diabetes (T1D) in high-risk individuals. Its primary mechanism involves modulating T-cell activity to preserve insulin-producing beta cells.

As of 2023, TESLASCAN holds a Breakthrough Therapy designation from the FDA and is in Phase 3 clinical trials aiming for approval in the United States. The drug's potential to modify disease progression positions it as a candidate for disease-modifying therapy in T1D, a market with significant unmet need.

How does the current market landscape influence TESLASCAN's prospects?

The T1D treatment market exceeds $2.2 billion globally in 2023, driven by insulin therapy and glucose monitoring systems. However, no approved disease-modifying treatments exist for T1D to delay onset in high-risk populations.

Key competitive considerations include:

• Unmet medical need: High. TESLASCAN aims to delay T1D onset, a product category underserved by current therapies.
• Pipeline candidates: Other immunotherapies in late-stage development, such as those from Orgenesis and Imcyse, targeting autoimmune mechanisms.
• Regulatory environment: Supportive for innovative therapies with expedited pathways (e.g., Breakthrough Designation).

What are the projected commercialization timelines and financial implications?

Regulatory milestones

• FDA Phase 3 completion: Expected late 2023 or early 2024.
• Potential approval: Could occur by mid-2024 if trial outcomes are positive.
• Market launch: Anticipated within six months post-approval.

Revenue potential

Estimates based on unmet needs and lack of current disease-modifying options:

Scenario	Probability	Revenue Estimate (USD)	Notes
Optimistic (high uptake)	60%	$500 million - $1 billion	Large at-risk population (~1 million high-risk patients globally)
Moderate	30%	$200 million - $500 million	Moderate adoption, especially in North America and Europe
Pessimistic	10%	<$100 million	Regulatory delays, safety issues, or limited uptake

Cost considerations

• Development costs: Estimated at $300-400 million to reach Phase 3.
• Manufacturing: Scaled in-house, raw material costs moderate.
• Commercialization: Marketing and education costs in the initial years estimated at $100 million annually.

Market penetration assumptions

Assuming a conservative initial market share of 15-20% among eligible patients in the first three years, revenues could reach hundreds of millions.

What financial risks and opportunities are associated with TESLASCAN?

Risks

• Regulatory setbacks: Failure to demonstrate efficacy or safety could negate approval.
• Market acceptance: Limited if the treatment is viewed as only delaying, not preventing, T1D.
• Pricing constraints: Payer resistance to high costs without solid long-term data.

Opportunities

• First-in-class status: Potential to dominate the disease-modifying T1D market.
• Expansion possibilities: Use of immunotherapy in other autoimmune conditions.
• Partnership prospects: Collaborations with large pharma for global distribution.

How does TESLASCAN compare with similar therapies in development?

Therapy	Developer	Phase	Indication	Mechanism	Regulatory status
Teplizumab (TESLASCAN)	Provention Bio	Phase 3	T1D delay in high-risk individuals	Immune modulation via CD3 targeting	Breakthrough Therapy; pending approval
ImCYSE (IMCYSE)	Imcyse	Phase 2	T1D prevention	Autoantigen-specific immunotherapy	Not yet approved
ORG 10193 (Oreg=<?)	Orgenesis	Preclinical	T1D prevention	T-cell immune therapy	Experimental

Key regulatory considerations

The drug's Breakthrough Therapy status expedites development and review cycles but requires evidence of substantial improvement over existing options. Post-approval, payer negotiations will hinge on demonstrated long-term benefits and safety data.

Conclusion

TESLASCAN is positioned as a potential first disease-modifying therapy for T1D with a push toward market entry around 2024. Its success relies on clinical trial outcomes, regulatory approval, and market acceptance. Financially, the drug offers substantial upside given the high unmet need, but risks include approval delays and market adoption barriers.

Key Takeaways

• TESLASCAN targets a significant unmet need in delaying T1D onset.
• Expected FDA approval around mid-2024 could unlock revenues in the hundreds of millions to over a billion dollars.
• Market success hinges on clinical efficacy, safety profile, and payer reimbursement strategies.
• Competitive landscape includes other immunotherapies in development, but TESLASCAN’s regulatory status provides an advantage.
• Long-term profitability depends on market penetration, global expansion, and potential indication extensions.

FAQs

1. When is TESLASCAN likely to receive FDA approval?

Likely mid-2024, contingent on Phase 3 trial outcomes demonstrating safety and efficacy.

2. What is the estimated market size for TESLASCAN?

The target market includes approximately 1 million high-risk individuals globally, with a potential revenue range of $200 million to over $1 billion annually post-launch.

3. What are the main challenges to TESLASCAN’s commercialization?

Regulatory approval hurdles, payer reimbursement negotiations, and skepticism regarding delaying rather than preventing T1D.

4. How does TESLASCAN compare to existing T1D treatments?

Current treatments focus solely on insulin replacement; TESLASCAN offers disease modification by delaying disease onset.

5. Are there any notable competitors in the pipeline?

Yes, including immunotherapies like ImCYSE and therapies from Orgenesis, but TESLASCAN’s FDA breakthrough status provides a competitive edge.

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References

1. Provention Bio. (2023). TESLASCAN clinical trial data. [Press release].
2. GlobalData. (2023). Diabetes market report.
3. U.S. Food and Drug Administration. (2022). Breakthrough Therapy Designation.