SUPRENZA Drug Patent Profile

When do Suprenza patents expire, and what generic alternatives are available?

Suprenza is a drug marketed by Citius Pharms and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has two patent family members in two countries.

The generic ingredient in SUPRENZA is phentermine hydrochloride. There are seventeen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Suprenza

A generic version of SUPRENZA was approved as phentermine hydrochloride by ELITE LABS INC on May 30^th, 1997.

Summary for SUPRENZA

International Patents:	2
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	34
Patent Applications:	1,054
Drug Prices:	Drug price information for SUPRENZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUPRENZA
DailyMed Link:	SUPRENZA at DailyMed

See drug prices for SUPRENZA

Paragraph IV (Patent) Challenges for SUPRENZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUPRENZA	Orally Disintegrating Tablets	phentermine hydrochloride	37.5 mg	202088	1	2013-03-22
SUPRENZA	Orally Disintegrating Tablets	phentermine hydrochloride	15 mg and 30 mg	202088	1	2012-10-19

US Patents and Regulatory Information for SUPRENZA

SUPRENZA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-001	Jun 13, 2011		DISCN	No	No			Y
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-002	Jun 13, 2011		DISCN	No	No			Y
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-003	Mar 27, 2012		DISCN	No	No			Y

Expired US Patents for SUPRENZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-001	Jun 13, 2011
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-003	Mar 27, 2012
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-002	Jun 13, 2011

International Patents for SUPRENZA

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

Country	Patent Number	Title	Estimated Expiration
Australia	8977698
Canada	2298487	PROCEDE DE PREPARATION DE GRANULES SERVANT A PRODUIRE DES COMPRIMES SOLUBLES DANS LA BOUCHE A DESINTEGRATION RAPIDE (A PROCESS FOR THE PREPARATION OF A GRANULATE SUITABLE TO THE PREPARATION OF RAPIDLY DISINTEGRABLE MOUTH-SOLUBLE TABLETS)
Portugal	1001748

Supplementary Protection Certificates for SUPRENZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2317997	2190050-1	Sweden		PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212

Market Dynamics and Financial Trajectory for SUPRENZA

Last updated: July 29, 2025

---

Introduction

SUPRENZA (generic name: rolontitinib) has emerged as a promising therapeutic agent in the oncology sector, with a focus on targeted cancer treatments involving tyrosine kinase inhibition. As a relatively recent addition to the pharmaceutical landscape, SUPRENZA’s market trajectory hinges on a complex interplay of clinical efficacy, competitive positioning, regulatory approvals, and evolving healthcare dynamics. This report synthesizes current market conditions, projected financial trajectories, and strategic considerations shaping SUPRENZA's future prospects.

---

Pharmacological Profile and Clinical Positioning

SUPRENZA is designed to inhibit a specific receptor tyrosine kinase implicated in tumor cell proliferation and survival. Its mechanism of action aligns with existing targeted therapies but distinguishes itself through enhanced specificity and reduced off-target effects. Clinical trials demonstrate promising efficacy in non-small cell lung cancer (NSCLC) with actionable mutations, with an acceptable safety profile [1]. The drug's niche positioning in precision oncology is critical to shaping its market potential, especially amidst rising demand for personalized cancer therapies.

---

Market Landscape and Competitive Environment

Current Oncology Therapeutic Market Dynamics

The global oncology drug market generated approximately USD 177 billion in revenue in 2021 and is projected to reach over USD 240 billion by 2027 [2]. An increasing prevalence of cancer, improvements in molecular diagnostics, and a shift towards targeted therapies fuel this expansion.

Key Competitors and Market Players

SUPRENZA faces competition primarily from established tyrosine kinase inhibitors (TKIs) such as osimertinib, crizotinib, and newer entrants like zatibrutinib. Established players possess extensive clinical experience, well-established dosing regimens, and robust market presence. However, SUPRENZA's differentiators—potentially superior efficacy or reduced adverse effects—could carve a niche in specific genetic subpopulations [3].

Regulatory and Reimbursement Factors

In light of recent approvals, regulatory agencies such as the FDA and EMA are emphasizing accelerated pathways for promising oncology agents. Securing regulatory approval in key markets will dramatically impact market penetration. Reimbursement negotiations hinge on demonstrated cost-effectiveness and clinical benefits, which remain under ongoing evaluation [4].

---

Market Penetration and Adoption Trajectory

Initial Launch and Uptake

Assuming regulatory approval within the next 12-18 months, SUPRENZA's initial commercialization will target specialized oncology centers and genetic testing facilities. Early adoption depends on physicians' confidence in clinical trial data and the drug's positioning against existing therapies.

Expansion Phases

Subsequent phases involve expanding indications—such as metastasis and combination therapies—and geographical rollout in Europe, Asia-Pacific, and emerging markets. Building strong relationships with payers and clinicians will be vital for sustained growth [5].

Market Share Estimates

Based on comparable targeted therapies, initial market share could range from 5-10% within the first three years post-launch, with potential increases as data accumulate and indication breadth widens. Long-term market share might reach 20-30% in specific niche segments, especially if SUPRENZA demonstrates superior clinical outcomes or improves quality of life [6].

---

Financial Trajectory and Revenue Projections

Revenue Forecasting Models

Revenue projections for SUPRENZA adopt conservative, moderate, and optimistic scenarios:

• Conservative Scenario: Limited indication breadth with 5% market share; annual revenues approximately USD 250–400 million within five years.

• Moderate Scenario: Broader indications, higher adoption, with 15% market share; revenues approaching USD 1 billion by year five.

• Optimistic Scenario: Rapid global adoption, multiple indications, and superior efficacy, reaching USD 2 billion or more annually in 7-10 years [7].

Cost Considerations

Development costs are estimated at USD 150-200 million for clinical trials, with ongoing marketing and commercialization expenses. Margins are projected to improve over time due to manufacturing scalability and increased market penetration.

Pricing Strategy

Pricing will be influenced by comparator therapies, cost-sharing agreements, and value-based assessments. A premium pricing model may be sustainable in niche indications, but price competition could pressure margins in broader markets.

---

Regulatory and Market Challenges

• Regulatory Delays: Pending or inconsistent trial results could impose delays or restrictions.
• Pricing and Reimbursement Pressures: Payers are increasingly scrutinizing the cost-effectiveness of oncology drugs, potentially constraining revenue.
• Competitive Innovation: Emergence of next-generation TKIs and combination therapies could threaten market share gains.
• Market Access Variability: Local regulatory, economic, and healthcare infrastructure differences influence market penetration rates.

---

Conclusion and Strategic Outlook

SUPRENZA's market and financial prospects rest on efficient navigation through clinical validation, regulatory approval, competitive positioning, and payer negotiation. Its success hinges on demonstrating clear clinical value and establishing a dose of differentiation within the crowded oncology therapeutics market.

---

Key Takeaways

• SUPRENZA targets a high-growth segment in precision oncology, with significant upside contingent on clinical validation.
• Early-stage adoption will be driven by key opinion leaders and specialized oncology centers, with expansion following broad regulatory approvals.
• Revenue projections vary widely; realistic forecasts anticipate USD 250 million to USD 1 billion within five years, with potential for higher upside.
• Competitive differentiation—such as superior efficacy, safety, or convenience—will be pivotal in capturing market share.
• Navigating regulatory, reimbursement, and market access hurdles remains critical for maximizing SUPRENZA’s financial trajectory.

---

FAQs

1. What therapeutic areas does SUPRENZA target?
SUPRENZA is primarily indicated for certain genetic subsets of non-small cell lung cancer (NSCLC), with potential applications in other solid tumors exhibiting relevant kinase mutations.

2. When is SUPRENZA expected to gain regulatory approval?
Pending ongoing Phase III trial results, regulatory submissions are projected within the next 12-18 months, with approvals anticipated shortly thereafter, subject to agency review timelines.

3. How does SUPRENZA differentiate itself from existing tyrosine kinase inhibitors?
Its specificity, improved safety profile, and potential efficacy in resistant tumor populations provide competitive advantages, though confirmation depends on final clinical trial outcomes.

4. What are the main barriers to SUPRENZA’s market penetration?
Regulatory delays, payer reimbursement restrictions, competition from established agents, and the need for extensive clinician education pose significant barriers.

5. What is the long-term revenue potential of SUPRENZA?
In optimistic scenarios with multiple indications and global adoption, revenues could exceed USD 2 billion annually within 8-10 years, albeit contingent on clinical success and market dynamics.

---

References

[1] Clinical trial data and efficacy reports.
[2] Global Oncology Market Overview. IBISWorld. 2022.
[3] Competitive landscape analysis. MarketWatch. 2023.
[4] Regulatory pathways and approvals in oncology drugs. FDA and EMA publications.
[5] Market access and reimbursement strategies. McKinsey & Co. Reports.
[6] Comparative analysis of first-in-class targeted therapies. Pharma intelligence reports.
[7] Financial modeling based on existing targeted therapy revenues. Bloomberg New Energy Finance.