TRIPHASIL-21 Drug Patent Profile

When do Triphasil-21 patents expire, and when can generic versions of Triphasil-21 launch?

Triphasil-21 is a drug marketed by Wyeth Pharms and is included in one NDA.

The generic ingredient in TRIPHASIL-21 is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for TRIPHASIL-21

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	2
Patent Applications:	518
DailyMed Link:	TRIPHASIL-21 at DailyMed

Recent Clinical Trials for TRIPHASIL-21

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

Sponsor	Phase
Desmond Tutu HIV Centre	N/A
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3

See all TRIPHASIL-21 clinical trials

US Patents and Regulatory Information for TRIPHASIL-21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984		DISCN	Yes	No

Expired US Patents for TRIPHASIL-21

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984	3,666,858
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984	3,959,322
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984	3,957,982
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984	3,850,911

International Patents for TRIPHASIL-21

See the table below for patents covering TRIPHASIL-21 around the world.

Country	Patent Number	Title	Estimated Expiration
Netherlands	139310
Canada	1029303	METHOD OF CONTRACEPTION BY THE ADMINISTRATION OF STAGE-COMBINATION PREPARATIONS
Germany	1593382
Italy	1061783	PROCEDIMENTO PER PREPARARE COMPOSTI STEROIDALI
Philippines	9896	2-POLYCARBONALKYL-1,3-CYCLOPENTANEDIONE

Supplementary Protection Certificates for TRIPHASIL-21

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211

Market Dynamics and Financial Trajectory for TRIPHASIL-21

Last updated: July 29, 2025

Introduction

TRIPHASIL-21 (also referenced as IL-21 based therapeutics) has garnered significant attention within the oncology and immunology sectors. Originally developed by Juno Therapeutics and later acquired by Boehringer Ingelheim, TRIPHASIL-21 presents an innovative approach leveraging IL-21 cytokine modulation to enhance immune response against cancers. Its positioning in the market reflects a combination of unmet medical needs, competitive landscape, regulatory considerations, and potential commercialization strategies. This analysis evaluates these factors to understand TRIPHASIL-21’s market potential and forecast its financial trajectory.

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Market Overview and Therapeutic Context

Interleukin-21 (IL-21) is a cytokine pivotal in immune regulation, notably in T-cell and natural killer (NK) cell activation. Abnormal IL-21 signaling pathways are implicated in several cancers and autoimmune disorders. Therapeutic modulation of IL-21 aims to harness immune responses more effectively, especially in hematologic malignancies such as non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, and certain solid tumors.

The global immuno-oncology market exceeds $40 billion, with IL-21-based immunotherapies positioned as promising candidates owing to their unique mechanism of boosting immune-mediated tumor destruction. Despite the potential, various IL-21 therapeutics are still emerging and face a competitive landscape populated by immune checkpoint inhibitors, CAR-T cell therapies, and other cytokine-based interventions.

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Competitive Landscape and Market Drivers

1. Existing and Emerging Competitors

While TRIPHASIL-21 is among the leading IL-21 therapeutics in clinical development, it faces competition from:

• Other cytokine therapies, such as IL-2 and IL-15 variants.
• Immune checkpoint inhibitors like pembrolizumab and nivolumab, which have established market presence in multiple cancers.
• Next-generation cell-based therapies, including CAR-Ts, with transformative effects in hematologic malignancies.

2. Unmet Medical Needs

Many patients with relapsed or refractory cancers lack effective options, creating substantial demand-supply gaps. TRIPHASIL-21’s potential to enhance immune responses offers an avenue to address these needs, especially for indications like advanced NHL or combination therapies where current treatments fall short.

3. Regulatory and Reimbursement Factors

Regulatory agencies such as the FDA have shown openness to innovative cytokine therapies, especially through expedited pathways like Breakthrough Therapy designation. Positive clinical outcomes or phase III trial success could accelerate approval and reimbursement pathways, incentivizing commercialization.

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Clinical Development and Regulatory Milestones

TRIPHASIL-21’s clinical pipeline, primarily centered on hematologic cancers, has achieved pivotal milestones:

• Phase II trials demonstrated promising response rates and manageable safety profiles.
• Regulatory interactions secured fast-track designations.
• Anticipated phase III trials hold the potential for market approval within the next 2-3 years, contingent on clinical success.

The trajectory of its regulatory approvals profoundly influences market entry and revenue assumptions. Delay or failure to demonstrate efficacy could diminish its prospects, whereas clear clinical benefits would bolster market position.

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Market Opportunities and Forecast

Indications and Market Penetration

• Hematologic cancers: Initiatives targeting non-Hodgkin lymphoma, Hodgkin lymphoma, multiple myeloma.
• Solid tumors: Emerging exploration in melanoma, lung, or breast cancers, especially in combination regimens.

Pricing and Reimbursement

Pricing estimates for IL-21 therapies typically range from $20,000 to $50,000 per treatment cycle, influenced by treatment setting, administration complexity, and pharmacodynamics. Reimbursement will depend on demonstrated clinical benefit, and value-based pricing models are likely.

Financial Trajectory Estimates (2023-2030)

• Initial Launch (2025-2027): Limited market penetration driven by clinical approval and cautious adoption, projected revenues of $100 million to $300 million annually.
• Mid-term Growth (2028-2030): Expansion through additional indications, combination protocols, and expanded geographic access could increase revenues to $1 billion+.
• Long-Term Outlook: A mature portfolio with potential line extension or biosimilar competition may temper growth, but with established market shares, revenues could stabilize around $1.5 billion annually.

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Key Challenges and Risks

• Clinical Efficacy and Safety: Demonstrating substantial superiority over existing therapies is critical.
• Competition: Emergence of superior cytokine or cellular therapies may diminish TRIPHASIL-21’s market share.
• Regulatory Hurdles: Delays or adverse trial outcomes could impact timeline and commercialization.
• Pricing and Reimbursement: Costed at a premium, reimbursement policies will influence market access.

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Strategic Considerations

• Partnerships and Collaborations: Aligning with biotech firms or academic centers could accelerate development.
• Combination Strategies: Positioning TRIPHASIL-21 as part of combination regimens with checkpoint inhibitors may enhance efficacy and market appeal.
• Geographic Expansion: Early focus on North America and Europe, followed by emerging markets, will maximize revenues.
• Patient Selection and Biomarkers: Developing predictive biomarkers can optimize targeting, improve response rates, and justify premium pricing.

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Conclusion

TRIPHASIL-21 stands as a promising immunotherapy advancing through clinical development with substantial market opportunities within oncology. Success hinges on clinical efficacy, regulatory approval, and strategic commercialization. Its financial trajectory suggests substantial upside potential in the mid to long term, provided clinical and regulatory challenges are navigated successfully.

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Key Takeaways

• Market Potential: Targeting high unmet need cancers with cytokine-based immunotherapies positions TRIPHASIL-21 for significant long-term revenue growth.
• Competitive Edge: Its mechanism of amplifying immune responses offers a differentiation advantage over traditional therapies.
• Clinical Momentum: Progress into phase III trials will be pivotal for market entry and value realization.
• Pricing and Reimbursement: Premium pricing justified by clinical benefits and combination strategies can optimize profitability.
• Strategic Positioning: Partnerships, biomarker development, and geographic expansion are essential for maximizing market penetration.

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FAQs

1. When is TRIPHASIL-21 expected to reach the market?
Pending successful phase III trial results and regulatory approval, TRIPHASIL-21 could be commercially available by 2025–2027.

2. What are the primary indications for TRIPHASIL-21?
The main targets include hematologic malignancies such as non-Hodgkin lymphoma, Hodgkin lymphoma, and potentially solid tumors in combination therapies.

3. How does TRIPHASIL-21 compare with existing immunotherapies?
It offers a novel cytokine approach that enhances immune cell activation, potentially providing benefits where checkpoint inhibitors or cellular therapies have limitations.

4. What are the major risks facing TRIPHASIL-21’s commercialization?
Key risks include clinical trial failures, competitive therapies gaining prominence, regulatory delays, and reimbursement challenges.

5. How can pharmaceutical companies leverage TRIPHASIL-21’s market opportunities?
Through strategic partnerships, development of combination regimens, biomarker-driven patient selection, and expansion into global markets.

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Sources

1. [1] Market analysis of immuno-oncology sector, Bloomberg Intelligence, 2022.
2. [2] Clinical trial data and regulatory status, Boehringer Ingelheim, 2023.
3. [3] Pricing strategies and reimbursement outlook, IQVIA Institute, 2022.