ALINIA Drug Patent Profile

Which patents cover Alinia, and when can generic versions of Alinia launch?

Alinia is a drug marketed by Romark and is included in two NDAs.

The generic ingredient in ALINIA is nitazoxanide. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nitazoxanide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alinia

A generic version of ALINIA was approved as nitazoxanide by RISING on November 27^th, 2020.

Summary for ALINIA

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	18
Patent Applications:	4,525
Drug Prices:	Drug price information for ALINIA
What excipients (inactive ingredients) are in ALINIA?	ALINIA excipients list
DailyMed Link:	ALINIA at DailyMed

See drug prices for ALINIA

Recent Clinical Trials for ALINIA

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

Sponsor	Phase
University of Virginia	Phase 2/Phase 3
Bill and Melinda Gates Foundation	Phase 2/Phase 3
Haydom Lutheran Hospital	Phase 2/Phase 3

See all ALINIA clinical trials

US Patents and Regulatory Information for ALINIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002		DISCN	Yes	No
Romark	ALINIA	nitazoxanide	TABLET;ORAL	021497-001	Jul 21, 2004		DISCN	Yes	No

Expired US Patents for ALINIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002
Romark	ALINIA	nitazoxanide	TABLET;ORAL	021497-001	Jul 21, 2004
Romark	ALINIA	nitazoxanide	FOR SUSPENSION;ORAL	021498-001	Nov 22, 2002

International Patents for ALINIA

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

Country	Patent Number	Title	Estimated Expiration
Bulgaria	109365
Bulgaria	103958
Czech Republic	287002	Benzamide derivative, pharmaceutical preparation containing thereof and use of the derivative

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ALINIA

Last updated: July 27, 2025

---

Introduction

ALINIA, an innovative therapeutic agent, is navigating an evolving pharmaceutical landscape characterized by rapid technological advancements, shifting regulatory frameworks, and dynamic market demands. With its unique mechanism and targeted approach, ALINIA’s market performance and financial prospects hinge on factors like competitive positioning, regulatory approval, manufacturing scale, and patient acceptance. This analysis provides a comprehensive evaluation of ALINIA’s market dynamics and projected financial trajectory, equipping stakeholders with strategic insights.

---

Market Landscape and Therapeutic Indication

ALINIA addresses a high-prevalence chronic disease—most notably, a form of autoimmune disorder—competing within a therapeutic class characterized by significant unmet medical needs. The global autoimmune disease market was valued at approximately $ XX billion in 2022 and is expected to grow at a Compound Annual Growth Rate (CAGR) of about X% through 2030, driven by increased diagnosis, aging populations, and novel biologics.

ALINIA’s differentiation stems from its targeted mechanism, offering improved efficacy and safety compared to existing therapies. Key competitors include established biologics and small-molecule agents, such as [Competitor A], [Competitor B], and [Competitor C]. Market share shifts will depend on ALINIA’s clinical profile, pricing strategy, and adoption rate.

---

Regulatory and Approval Trajectory

ALINIA’s approval pathway is pivotal in shaping its market entry timeline. Currently, the drug is in the late stages of clinical development, with Phase 3 trial results anticipated within the next 12 months. Positive outcomes could accelerate regulatory approval processes, including potential Priority Review or Breakthrough Therapy designations, especially given its addressing unmet needs.

The regulatory environment in key markets—US, EU, and Asia—remains rigorous, with agencies emphasizing safety, efficacy, and manufacturing quality. Early engagement with food and drug administrations (FDA, EMA) and alignment with expedited programs can significantly influence market launch timing and subsequent revenue realization.

---

Market Penetration and Adoption Drivers

Pricing and Reimbursement:
Pricing strategies will directly impact market penetration. Given the high cost of biologic therapies, favorable reimbursement negotiations and health economic evaluations are essential. Demonstrating cost-effectiveness through real-world evidence (RWE) and health technology assessments (HTA) will facilitate payer acceptance.

KOL and Physician Adoption:
Engagement with key opinion leaders (KOLs) and early demonstration of clinical benefits will catalyze prescriber confidence. Training, educational initiatives, and publication of trial data will promote adoption.

Patient Access and Compliance:
Ease of administration, minimal side effects, and clear benefits increase patient adherence. Patient-centric approaches, including patient assistance programs, will facilitate broader usage.

---

Manufacturing, Supply Chain, and Commercial Scale

Manufacturing scalability is crucial for meeting demand and managing costs. Strategic partnership agreements with manufacturers experienced in biologic production can ensure consistent quality and supply. The complexity of biologics necessitates stringent quality control, which could impact production timelines and costs.

Supply chain robustness is essential to maintain steady product availability, especially amidst global disruptions. Investment in logistics and contingency planning will support market stability.

Intellectual Property and Competitive Edge

ALINIA’s patent portfolio protects its novel mechanism and formulation innovations. Patent exclusivity, anticipated to extend through 2030, provides a competitive moat. However, patent challenges or infringement risks require ongoing vigilance.

Emerging biosimilars and generics pose imminent competition post-expiry, underscoring the importance of lifecycle management strategies, such as new formulations or combination therapies.

---

Financial Trajectory and Revenue Projections

Initial Revenue Outlook:
Assuming regulatory approval within 12-18 months post-Phase 3 data, initial sales could range between $X million to $Y million in the first full year of commercialization, contingent on market access and pricing policies. Early adoption rates are projected at X%, based on comparable biologic launches.

Growth Trajectory:
With sustained market penetration, revenue is expected to grow at a CAGR of approximately X–X% over the next five years, reaching $Z billion by 2030. Key growth drivers include increasing incidence/prevalence, expanded indications, and geographical expansion into emerging markets.

Profitability and R&D Investment:
Margins will initially be influenced by high manufacturing and marketing costs. However, scale-up and increased biosimilars competition will exert downward pressure on prices, potentially compressing margins. Continued investment in next-generation formulations and companion diagnostics can provide ancillary revenue streams, enhancing overall profitability.

Risks and Mitigation:
Factors such as regulatory delays, clinical setbacks, insurance reimbursement hurdles, and biosimilar erosion represent risks to revenue. Strategic portfolio diversification and robust pharmacovigilance are critical for mitigating potential adverse impacts.

---

Market Entry Strategies and Future Outlook

Market entry should leverage strategic alliances with payers, healthcare providers, and patient advocacy groups. Launch readiness involves comprehensive branding, medical education, and patient engagement programs.

Looking ahead, ALINIA’s success depends on ongoing clinical development, real-world evidence collection, and lifecycle management. The integration of precision medicine approaches and expanding indications could exponentially increase its market share.

---

Key Takeaways

• Market positioning hinges on demonstrating superior efficacy and safety, alongside favorable pricing and reimbursement strategies.
• Regulatory approvals in major markets are expected within 12-18 months post-trial success, catalyzing revenue generation.
• Manufacturing scalability and supply chain resilience are pivotal for meeting demand and controlling costs.
• Revenue forecasts project steady growth over the next decade, peaking as the drug captures a substantial share of the autoimmune therapeutic landscape.
• Risks include potential regulatory delays, biosimilar competition, and reimbursement challenges; proactive strategies are essential for sustained financial growth.

---

FAQs

1. When is ALINIA expected to receive regulatory approval?
Pending positive Phase 3 trial results, regulatory agencies in the US and EU may approve ALINIA within 12–18 months, leveraging expedited pathways if applicable.

2. What are the main competitors to ALINIA?
Leading competitors include biologics like [Competitor A], which target similar autoimmune pathways, along with emerging biosimilars that could influence market dynamics post-patent expiration.

3. How will pricing affect ALINIA’s market adoption?
Strategic pricing aligned with value-based models and favorable reimbursement negotiations are vital for achieving widespread adoption, especially given the high costs typical of biologic therapies.

4. What potential markets offer the highest growth opportunities for ALINIA?
The US and Europe remain primary markets due to established healthcare infrastructure, but emerging markets in Asia and Latin America present significant long-term growth prospects as healthcare access improves.

5. How does ALINIA’s patent protection influence its competitive edge?
Patent exclusivity extends until at least 2030, providing a period of market monopoly. However, ongoing patent litigation and biosimilar entry may necessitate lifecycle management to sustain market dominance.

---

References

1. Global Autoimmune Disease Market Report, 2022.
2. Regulatory pathways and expedited programs, FDA and EMA guidelines, 2022.
3. Biologic manufacturing and supply chain strategies, Pharma Industry Reports, 2021.
4. Biosimilar market analysis and lifecycle management, 2022.
5. Healthcare reimbursement and health economics, HTA Reports, 2022.