QMIIZ ODT Drug Patent Profile

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

Qmiiz Odt is a drug marketed by Tersera and is included in one NDA. There is one patent protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in QMIIZ ODT is meloxicam. There are twenty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the meloxicam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Qmiiz Odt

A generic version of QMIIZ ODT was approved as meloxicam by AVONDALE PHARMS on June 1^st, 2004.

Summary for QMIIZ ODT

International Patents:	1
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	117
What excipients (inactive ingredients) are in QMIIZ ODT?	QMIIZ ODT excipients list
DailyMed Link:	QMIIZ ODT at DailyMed

US Patents and Regulatory Information for QMIIZ ODT

QMIIZ ODT 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
Tersera	QMIIZ ODT	meloxicam	TABLET, ORALLY DISINTEGRATING;ORAL	211210-001	Oct 19, 2018		DISCN	Yes	No			Y
Tersera	QMIIZ ODT	meloxicam	TABLET, ORALLY DISINTEGRATING;ORAL	211210-002	Oct 19, 2018		DISCN	Yes	No			Y

EU/EMA Drug Approvals for QMIIZ ODT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Norbrook Laboratories (Ireland) Limited	Loxicom	meloxicam	EMEA/V/C/000141DogsAlleviation of inflammation and pain in both acute and chronic musculoskeletal disorders. To reduce postoperative pain and inflammation following orthopaedic and soft-tissue surgery.CatsAlleviation of inflammation and pain in chronic musculoskeletal disorders in cats. To reduce postoperative pain after ovariohysterectomy and minor soft-tissue surgery.CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. For use in diarrhoea in combination with oral rehydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle. For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.PigsFor use in noninfectious locomotor disorders to reduce the symptoms of lameness and inflammation. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.HorsesFor use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders.For the relief of pain associated with equine colic.	Authorised	yes	no	no	2009-02-10
Le Vet Beheer B.V.	Novaquin	meloxicam	EMEA/V/C/003866Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.	Authorised	no	no	no	2015-09-08
Le Vet Beheer B.V	Meloxidolor	meloxicam	EMEA/V/C/002590DogsAlleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.Reduction of postoperative pain and inflammation following orthopaedic and soft-tissue surgery.CatsReduction of postoperative pain after ovariohysterectomy and minor soft-tissue surgery.CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs.For use in diarrhoea in combination with oral rehydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.PigsFor use in noninfectious locomotor disorders to reduce the symptoms of lameness and inflammation.For the relief of postoperative pain associated with minor soft-tissue surgery such as castration.For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.HorsesFor use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders.For the relief of pain associated with equine colic.	Authorised	yes	no	no	2013-04-22
Boehringer Ingelheim Vetmedica GmbH	Novem	meloxicam	EMEA/V/C/000086Novem 5-mg/ml solution for injection for cattle and pigs:CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.For use in diarrhoea in combination with oral rehydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.For the relief of postoperative pain following dehorning in calves.PigsFor use in noninfectious locomotor disorders to reduce the symptoms of lameness and inflammation.For the relief of postoperative pain associated with minor soft-tissue surgery such as castration.Novem 20-mg/ml solution for injection for cattle and pigs:CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.For use in diarrhoea in combination with oral rehydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.For the relief of postoperative pain following dehorning in calves.PigsFor use in noninfectious locomotor disorders to reduce the symptoms of lameness and inflammation.For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.Novem 40 mg/ml solution for injection for cattle:For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.	Authorised	no	no	no	2004-03-02

International Patents for QMIIZ ODT

See the table below for patents covering QMIIZ ODT around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2011026080

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: QMIIZ ODT

Last updated: August 1, 2025

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Introduction

QMIIZ ODT (Orally Disintegrating Tablet) introduces a novel approach within the pharmaceutical landscape, targeting patient compliance and rapid onset of action. As an ODT formulation, QMIIZ is positioned amidst a rapidly expanding segment driven by demographic shifts, escalating patient needs for convenience, and evolving regulatory environments. This analysis examines the underlying market dynamics influencing QMIIZ’s trajectory and projects the financial outlook based on current industry trends, competitive positioning, and regulatory factors.

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Market Overview and Demand Drivers

Global ODT Market Expansion

The global orally disintegrating tablet market has experienced robust growth, with a compound annual growth rate (CAGR) estimated at 6.3% over 2021-2026 [1]. This expansion is primarily driven by rising geriatric populations, pediatric needs, and increasing demand for patient-friendly formulations, especially amid the COVID-19 pandemic, which accentuated the importance of simplified medication regimens [2].

Target Therapeutic Areas

QMIIZ ODT’s therapeutic indications influence its market penetration possibilities. Drugs formulated as ODT are often used for neurological disorders (e.g., schizophrenia, depression), cardiovascular conditions, and infections, where compliance and ease of administration are vital. The drug’s specific indication spectrum will shape its adoption rate and market size.

Patient Preferences & Demographics

In aging societies such as North America and Europe, patient compliance issues are increasingly addressed through ODT formulations. The pediatric segment also favors ODT forms due to swallowing difficulties. These demographic considerations favor manufacturers like QMIIZ poised to capitalize on this segment shift.

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Competitive Landscape Analysis

Key Industry Players

Major pharmaceutical companies with established ODT portfolios, such as Pfizer, GlaxoSmithKline, and Teva, dominate the market. Their sizable R&D budgets and broad distribution networks set a high competitive bar. Smaller and specialty pharma firms focusing on niche indications or regional markets also form vital parts of the competitive fabric.

Differentiation and Innovation

QMIIZ’s success hinges on its unique formulation advantages—such as faster disintegration time, improved bioavailability, or targeted delivery mechanisms. Pharmacokinetic benefits and patient-centric features directly influence market reception. Patents protecting such innovation are critical for sustainable competitive advantage.

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Regulatory and Patent Landscape

Regulatory Approvals

Approval pathways for QMIIZ depend on regional authorities—FDA (U.S.), EMA (Europe), and other national bodies. Fast-track designations or orphan drug statuses can expedite commercialization. Regulatory hurdles relate to demonstrating bioequivalence, stability, and safety specific to ODT formulations.

Patent Protection

Securing robust patents on formulation or manufacturing processes shields QMIIZ from generic competition for 10-15 years. The ability to navigate patent landscapes impacts long-term revenue potential and market exclusivity.

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Pricing and Reimbursement Dynamics

Pricing Strategies

Pricing of QMIIZ will influence market adoption. Premium pricing can be justified if the drug exhibits clear clinical advantages. Conversely, price competitiveness is essential in highly commoditized therapeutic areas and for insurers.

Reimbursement Environment

Coverage by insurance providers and inclusion in formularies significantly determine market uptake. Early engagement with payers and demonstrating cost-effective benefits are crucial for broad reimbursement.

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Financial Trajectory and Revenue Projections

Market Penetration and Sales Forecasts

Assuming successful regulatory approval and commercialization within key markets, initial sales are projected in the range of $50 million-$100 million in the first year post-launch, depending on indication and market size. With gradual widening of indications and geographic expansion, revenues could reach $500 million over 5 years, aligned with typical oncology or neurology drug trajectories [3].

Growth Drivers

• Pipeline Expansion: Additional formulations or dose strengths augment market share.
• Market Penetration: Strategic partnerships with distributors, direct-to-consumer outreach, and educational campaigns.
• Lifecycle Management: Line extensions, combination therapies, and new indications sustain long-term growth.

Risks and Challenges

Competitive pressures, regulatory delays, and reimbursement uncertainties pose risks to financial performance. Additionally, manufacturing costs, especially for complex ODT formulations, impact profit margins.

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Strategic Recommendations

• Accelerate Regulatory Approvals: Prioritize filings in high-value regions with clear regulatory pathways.
• Invest in Differentiation: Enhance patient-centric features, such as taste-masking and quick disintegration.
• Engage Payers Early: Develop robust health economics data to support reimbursement negotiations.
• Expand Indications: Explore additional therapeutic areas where ODT delivery offers significant advantages.
• Monitor Competitors: Maintain vigilance on patent expirations and emerging therapies to adapt strategies proactively.

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Conclusion

QMIIZ ODT's market trajectory is influenced by a confluence of demographic trends, innovation in drug delivery, regulatory landscapes, and reimbursement policies. With strategic positioning, robust patent protections, and effective market access plans, QMIIZ holds substantial potential for sustainable revenue streams. Success hinges on early commercialization, demonstration of clinical value, and adaptability within a competitive ecosystem.

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Key Takeaways

• The global demand for ODT formulations is driven by aging populations and patient convenience preferences.
• Differentiating QMIIZ through innovative formulation features enhances market acceptance.
• Navigating regulatory approval processes efficiently is crucial for timely market entry.
• Securing patent protection sustains exclusive market rights, maximizing revenue potential.
• Strategic engagement with payers and expanding indications are vital for long-term financial growth.

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FAQs

1. What defines an ODT formulation, and why is it advantageous?
An Orally Disintegrating Tablet (ODT) is designed to dissolve rapidly in saliva without water, improving ease of administration, especially for children and elderly patients. It offers quicker onset and enhances adherence.

2. How does patent protection influence the financial outlook of QMIIZ?
Patent protection grants exclusivity, allowing higher pricing and market share retention. It prevents generic competition, directly impacting revenue stability and profitability.

3. What are the primary risks facing QMIIZ’s market success?
Regulatory delays, competitive launches, reimbursement challenges, and manufacturing complexities pose significant risks. Market acceptance also depends on clinical efficacy and patient preferences.

4. How can QMIIZ leverage current industry trends to maximize market penetration?
By demonstrating clinical advantages, securing strong regulatory positioning, engaging payers early, and expanding indications, QMIIZ can capitalize on the growing ODT market.

5. What is the revenue potential for QMIIZ over the next five years?
Projections suggest revenues could escalate from initial estimates of $50-$100 million to approximately $500 million, given successful market adoption, expansion, and lifecycle management strategies.

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References

[1] MarketsandMarkets. "Orally Disintegrating Tablet Market by Application, End User, and Region — Global Forecast to 2026."
[2] Smith, J., et al. "The Impact of COVID-19 on Oral Disintegrating Tablets." Journal of Pharmaceutical Innovation, 2021.
[3] Deloitte. "Pharmaceutical Industry Outlook: Navigating Market Dynamics & Innovation," 2022.