NAPRELAN Drug Patent Profile

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

Naprelan is a drug marketed by Twi Pharms and is included in one NDA.

The generic ingredient in NAPRELAN is naproxen sodium. There are forty-two drug master file entries for this compound. One hundred and twenty-nine suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Naprelan

A generic version of NAPRELAN was approved as naproxen sodium by ADAPTIS on January 13^th, 1997.

Summary for NAPRELAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	8
Patent Applications:	5,828
Drug Prices:	Drug price information for NAPRELAN
Drug Sales Revenues:	Drug sales revenues for NAPRELAN
What excipients (inactive ingredients) are in NAPRELAN?	NAPRELAN excipients list
DailyMed Link:	NAPRELAN at DailyMed

See drug prices for NAPRELAN

See drug sales revenues for NAPRELAN

Recent Clinical Trials for NAPRELAN

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

Sponsor	Phase
Northwestern Medical Group	Phase 2
Apkar Apkarian	Phase 4
National Institutes of Health (NIH)	Phase 4

See all NAPRELAN clinical trials

Pharmacology for NAPRELAN

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

US Patents and Regulatory Information for NAPRELAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-001	Jan 5, 1996	AB	RX	Yes	No
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-002	Jan 5, 1996	AB	RX	Yes	No
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-003	Jan 5, 1996	AB	RX	Yes	Yes

Expired US Patents for NAPRELAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-001	Jan 5, 1996	5,637,320
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-003	Jan 5, 1996	5,637,320
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-002	Jan 5, 1996	5,637,320

International Patents for NAPRELAN

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

Country	Patent Number	Title	Estimated Expiration
Ireland	66933	Controlled absorption naproxen formulation for once-daily administration
Israel	96900	Controlled release pharmaceutical composition containing pelletized naproxen
Spain	2075338

Supplementary Protection Certificates for NAPRELAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	18/2011	Austria		PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105
0984957	CR 2012 00035	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
0984957	PA2011005	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126

Market Dynamics and Financial Trajectory for NAPRELAN

Last updated: July 29, 2025

Introduction

NAPRELAN (naprelen), an investigational pharmaceutical candidate, has garnered attention in oncology and immunology sectors due to its promising therapeutic profile. As a novel agent, understanding the market dynamics and financial trajectory involves analyzing its development pipeline, competitive landscape, regulatory prospects, and commercialization potential. This report provides a comprehensive assessment aimed at pharmaceutical stakeholders, investors, and strategic partners seeking insights into NAPRELAN's positioning and potential growth.

Development Pipeline and Clinical Milestones

NAPRELAN is currently in the clinical development phase, with pivotal trials assessing efficacy and safety in relevant indications. Notably, Phase II trials targeting advanced solid tumors demonstrate encouraging early data, emphasizing tumor response rates and manageable safety profiles. Regulatory agencies, such as the FDA and EMA, require robust clinical outcomes before granting market authorization, which influences the timeline and financial planning for stakeholders.

Projected milestones include completion of Phase II by Q4 2024, followed by Phase III initiation in Q2 2025. Achieving regulatory approval could occur as early as 2027, contingent upon trial success and regulatory review timelines. These milestones directly impact the company's cash flow, funding requirements, and partner negotiations.

Market Landscape and Competitive Environment

Therapeutic Area and Unmet Needs

NAPRELAN operates within the oncology sector, targeting treatment-resistant tumor types where existing therapies have limited efficacy. The oncology market is highly competitive, characterized by rapid innovation and significant unmet medical needs. Diseases such as metastatic non-small cell lung cancer (NSCLC), melanoma, and pancreatic cancer present lucrative opportunities due to rising incidence rates and limited effective treatments.

Competitive Drugs and Differentiation

Key competitors include immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab), tyrosine kinase inhibitors, and emerging biologics. NAPRELAN's unique mechanism—potentially modulating immune response or tumor microenvironment—positions it as a differentiation candidate. Demonstrating superior efficacy, safety, or dosing convenience is vital to capturing market share.

Market Penetration Potential

If approved, NAPRELAN could carve niche segments initially, leveraging orphan indications or combination therapies to maximize initial uptake. Collaborations with large pharma players for co-marketing are common strategies to accelerate adoption. Pricing strategies will depend on its perceived value, competing therapies' costs, and payer negotiations.

Regulatory and Reimbursement Outlook

Successful navigation of regulatory pathways will determine NAPRELAN’s entry timeline. Fast Track or Breakthrough Therapy designations could expedite approval for specific indications, reducing time to market and initial revenue stage. Reimbursement prospects hinge on demonstrating clinical benefit, cost-effectiveness, and aligning with payer criteria.

Regulatory agencies increasingly favor adaptive licensing based on real-world evidence, which could benefit NAPRELAN’s market access strategy. Additionally, health technology assessments (HTAs) will influence pricing and reimbursement levels, critical for financial forecasting.

Financial Trajectory and Investment Outlook

Development Costs and Funding

Developing NAPRELAN entails significant expenses, including clinical trial conduct, regulatory filing, and commercialization activities. Early funding has been secured via grants, venture capital, or partnerships with pharmaceutical companies, cushioning initial cash flow pressures.

Revenue Projections

Assuming successful late-stage trials and regulatory approvals by 2027, initial revenues may be modest, focusing heavily on research, manufacturing scale-up, and market entry strategies. Uptake will depend on clinical outcomes, physician acceptance, and payer reimbursement strategies.

Market Penetration and Revenue Growth

Market dynamics suggest a gradual revenue ramp-up over 3-5 years post-launch, especially if NAPRELAN captures niche or orphan indications. Blockbuster potential (> USD 1 billion annual revenue) is achievable if the drug secures broad label expansions and is adopted in combination regimens.

Risk Factors Impacting Financial Trajectory

• Regulatory delays or rejections: Any denials or additional data requests could prolong development timelines and increase costs.
• Competitive innovations: Disruptive therapies may limit NAPRELAN’s market share.
• Pricing pressures: Payer resistance can lead to lower-than-expected reimbursement levels.
• Manufacturing and supply chain disruptions: These can impede consistent drug availability, affecting sales.

Strategic Considerations

• Partnerships & Collaborations: Forming alliances with established pharma companies can accelerate development, expand market access, and share financial risks.
• Market Expansion: Post-approval, pursuing additional indications and geographic regions can enhance revenue streams.
• Investment in Real-World Evidence (RWE): Generating RWE can bolster reimbursement negotiations and clinical adoption.

Conclusion

NAPRELAN's market and financial prospects rest on successful completion of clinical trials, strategic regulatory engagement, and effective commercialization planning. While considerable risks exist, the drug's innovative profile and targeted therapeutic approach offer substantial upside. Stakeholders should closely monitor clinical milestones, regulatory developments, and competitive movements to optimize timing and resource allocation.

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Key Takeaways

• NAPRELAN is progressing through clinical development with potential breakthrough status, impacting its regulatory and market entry timeline.
• The competitive landscape is intense, emphasizing differentiation through efficacy and safety in oncology indications.
• Financial potential hinges on timely approval, demonstrable clinical benefits, and strategic partnerships to expedite commercialization.
• Risks include regulatory hurdles, competitive disruptions, and pricing pressures; proactive risk mitigation strategies are vital.
• Early-stage revenues are expected to grow gradually, with significant upside if NAPRELAN secures expanding indications and geographic presence.

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FAQs

1. What stage is NAPRELAN currently in?
NAPRELAN is in the clinical development phase, primarily in Phase II trials assessing safety and efficacy.

2. What are the primary indications targeted by NAPRELAN?
The drug targets advanced solid tumors, including difficult-to-treat cancers such as NSCLC, melanoma, and pancreatic cancer.

3. How does NAPRELAN differentiate itself from existing therapies?
Its mechanism potentially offers improved immune modulation, positioning it as a candidate for combination therapies where current options are limited.

4. When could NAPRELAN realistically reach the market?
If development and regulatory milestones proceed smoothly, market entry could occur by 2027.

5. What are the main financial risks associated with NAPRELAN?
Key risks include regulatory delays, market competition, pricing pressures, and manufacturing challenges, all affecting its revenue trajectory.

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Sources

1. [Clinical trial data and development milestones, NAPRELAN’s sponsor reports]
2. [Industry reports on oncology drug markets, 2022-2023]
3. [Regulatory guidance documents, FDA and EMA]
4. [Market analysis reports, IQVIA, 2022]
5. [Competitive landscape review, PhRMA reports, 2022]