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 and one Paragraph IV challenge.

The generic ingredient in QMIIZ ODT is meloxicam. There is one drug master file entry for this compound. Forty-eight 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

US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	117
Patent Applications:	2,542
What excipients (inactive ingredients) are in QMIIZ ODT?	QMIIZ ODT excipients list
DailyMed Link:	QMIIZ ODT at DailyMed

Paragraph IV (Patent) Challenges for QMIIZ ODT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QMIIZ ODT	Orally Disintegrating Tablets	meloxicam	7.5 mg and 15 mg	211210	1	2026-04-20

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	8,545,879		Y
Tersera	QMIIZ ODT	meloxicam	TABLET, ORALLY DISINTEGRATING;ORAL	211210-002	Oct 19, 2018		DISCN	Yes	No	8,545,879		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
Boehringer Ingelheim Vetmedica GmbH	Metacam	meloxicam	EMEA/V/C/000033Cats:Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures, e.g. orthopaedic and soft tissue surgery.Alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders.Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.Cattle:For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs.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 the relief of post-operative pain following dehorning in calves.For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.Dogs:Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.Horses:For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.For the relief of pain associated with equine colic.Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.Pigs: For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.For the relief of post-operative 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.Guinea pigs:Alleviation of mild to moderate post-operative pain associated with soft tissues surgery such as male castration.	Authorised	no	no	no	1998-01-07

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

QMIIZ ODT Market Dynamics, Patent Position, and Financial Trajectory

Last updated: August 10, 2026

QMIIZ ODT is Zydus Pharmaceuticals’ orally disintegrating meloxicam product for osteoarthritis pain. Its commercial opportunity is limited by extensive generic competition in conventional meloxicam tablets and capsules, but the orally disintegrating formulation creates a differentiated niche for patients who have difficulty swallowing tablets. Public disclosures do not report QMIIZ ODT revenue separately, so its financial trajectory must be assessed through product positioning, prescription economics, regulatory status, and Zydus’ broader U.S. portfolio.

What is QMIIZ ODT and how does it compete?

QMIIZ ODT contains meloxicam, a nonsteroidal anti-inflammatory drug, in 7.5-mg and 15-mg orally disintegrating tablets. The FDA approved QMIIZ ODT in 2019 for the management of osteoarthritis pain in adults.[1]

The product dissolves in the mouth without requiring a conventional tablet-swallowing process. It competes in three overlapping markets:

Market segment	Principal competitors	QMIIZ ODT position
Generic oral meloxicam	Generic tablets and capsules from multiple manufacturers	Higher-cost differentiated dosage form
Branded oral NSAIDs	Celebrex, Tivorbex, Duexis, Vimovo and others	Alternative for osteoarthritis pain
Specialized meloxicam products	Vivlodex capsules and Anjeso injection	Oral dosage-form option with administration convenience

QMIIZ ODT does not have a new active ingredient. Its commercial differentiation rests on delivery format, patient convenience, prescriber awareness, reimbursement, and pharmacy access.

What is the FDA regulatory status of QMIIZ ODT?

The FDA approved QMIIZ ODT under a new drug application for meloxicam orally disintegrating tablets. The approved strengths are 7.5 mg and 15 mg.[1]

FDA milestones

Milestone	Date or status
Active ingredient	Meloxicam
Dosage form	Orally disintegrating tablet
Strengths	7.5 mg and 15 mg
Indication	Osteoarthritis pain in adults
FDA approval	2019
Sponsor	Zydus Pharmaceuticals (USA) Inc.
Regulatory pathway	NDA-based approval
Biologic status	Not applicable
Biosimilar exposure	None

The product carries the class warnings associated with meloxicam and other NSAIDs, including cardiovascular thrombotic risk, gastrointestinal bleeding, renal toxicity, and fetal toxicity in later pregnancy.[1]

QMIIZ ODT is not a biologic, so biosimilar substitution and the Biologics Price Competition and Innovation Act do not apply. Competitive risk comes from generic meloxicam products and other NSAIDs.

When does QMIIZ ODT lose exclusivity?

QMIIZ ODT’s meaningful regulatory exclusivity is not equivalent to the exclusivity of a new chemical entity. Meloxicam was already approved and widely available in generic form before QMIIZ ODT entered the market.

The key commercial distinction is between:

1. Regulatory exclusivity for the approved formulation.
2. Patent protection for the orally disintegrating technology.
3. Practical market protection created by prescribing, reimbursement, and pharmacy distribution.

A new dosage form can qualify for a limited period of FDA marketing exclusivity when the application is supported by qualifying clinical investigations. That exclusivity is generally shorter than the five-year period available to a new chemical entity. Any formulation-related exclusivity associated with QMIIZ ODT would not prevent generic conventional meloxicam tablets from remaining on the market.

Exclusivity timeline

Period	Commercial significance
2019 approval	QMIIZ ODT entered as a differentiated meloxicam dosage form
Approximate early-life period	Potential formulation-related regulatory exclusivity, subject to FDA records
After initial exclusivity	Generic competition could target the product or rely on existing meloxicam alternatives
Long-term market	Value depends primarily on formulation differentiation and payer coverage

The FDA Orange Book remains the controlling source for listed patents, exclusivity codes, and any approved generic competition.[2] A conventional generic meloxicam product does not need to reproduce QMIIZ ODT’s orally disintegrating formulation to compete for the underlying osteoarthritis indication.

What patents protect QMIIZ ODT?

QMIIZ ODT’s potential patent value would be concentrated in formulation and dosage-form claims rather than composition-of-matter claims covering meloxicam itself.

Relevant patent categories include:

• Orally disintegrating tablet composition.
• Taste masking for meloxicam.
• Disintegration and dissolution performance.
• Excipients and manufacturing processes.
• Tablet compression and moisture-control methods.
• Pharmaceutical use claims involving osteoarthritis pain.

The public commercial record does not establish a long-duration, composition-of-matter patent estate for QMIIZ ODT. That limits the product’s ability to command durable premium pricing against generic meloxicam.

Formulation patent risk

Formulation patents can delay direct copies if they claim a narrow combination of ingredients or a defined manufacturing method. They are less effective against:

• Conventional meloxicam tablets.
• Alternative orally disintegrating formulations.
• Other non-oral NSAID products.
• Therapeutically substitutable drugs.

A formulation patent also requires commercial enforcement. For a product with limited disclosed sales, litigation economics may discourage aggressive enforcement unless the product gains substantial payer coverage or institutional adoption.

Does QMIIZ ODT have Orange Book-listed patents?

The Orange Book should be used to determine the current listed-patent position and any approved ANDA certifications. The central business issue is that even a valid formulation patent would not block existing generic meloxicam tablets.

A Paragraph IV challenge would be relevant if an ANDA applicant sought approval for a product that directly relied on a patent-listed QMIIZ ODT formulation or method claim. The applicant could certify that the patent is invalid, unenforceable, or would not be infringed. If the first substantially complete Paragraph IV certification is accepted, the challenger could potentially receive 180-day generic exclusivity under the Hatch-Waxman framework, subject to statutory conditions.[3]

No major, widely reported QMIIZ ODT Paragraph IV litigation has established a market-wide launch barrier comparable to the litigation surrounding major high-revenue branded drugs. The absence of material reported litigation is consistent with a relatively small commercial opportunity, although it does not prove that no patent disputes exist.

Which companies challenge QMIIZ ODT commercially?

The principal competitive pressure comes from manufacturers of generic meloxicam rather than from a single named challenger.

Competitive groups

Competitor group	Examples	Risk to QMIIZ ODT
Generic meloxicam manufacturers	Large and specialty generic companies	High on price and formulary economics
Branded NSAID products	Celebrex and other branded therapies	Moderate, depending on indication and payer
Meloxicam alternatives	Vivlodex and Anjeso	Moderate within the meloxicam franchise
Other oral NSAIDs	Naproxen, ibuprofen, diclofenac products	High therapeutic substitution risk
Compounded or specialty formulations	Limited pharmacy-based alternatives	Low to moderate

The most important substitute is a low-cost generic meloxicam tablet. QMIIZ ODT must demonstrate a clinical or practical benefit that justifies a higher acquisition cost.

How strong is the QMIIZ ODT patent estate?

The estate appears commercially moderate to weak when measured against large branded pharmaceutical standards.

Strengths

• Differentiated administration format.
• Potential adherence benefit for patients with swallowing difficulty.
• FDA-approved product with a defined indication.
• Possible formulation and manufacturing know-how.
• Opportunity for specialty pharmacy or selected prescriber channels.

Weaknesses

• No new active ingredient.
• Broad generic availability of meloxicam.
• No biosimilar or biologic barrier.
• Likely limited ability to prevent therapeutic substitution.
• Formulation claims may be narrow and vulnerable to design-around strategies.
• Public financial reporting does not show a material standalone revenue base.

QMIIZ ODT has more value as a lifecycle-management product than as a high-margin, long-duration exclusivity asset.

What is the market size for QMIIZ ODT?

The addressable patient population is large because osteoarthritis is common and meloxicam is widely prescribed. The addressable premium market for QMIIZ ODT is smaller.

The relevant commercial funnel is:

1. Adults requiring pharmacologic osteoarthritis pain treatment.
2. Patients selected for meloxicam therapy.
3. Patients with difficulty swallowing or a preference for orally disintegrating medication.
4. Patients whose insurance covers the product.
5. Patients for whom the prescriber and pharmacy accept the price premium.

Each step reduces the practical market opportunity. Most osteoarthritis patients can use lower-cost generic tablets, creating substantial pressure on QMIIZ ODT’s net price and prescription volume.

What is the financial trajectory of QMIIZ ODT?

Zydus does not publicly disclose a separate revenue line for QMIIZ ODT in its standard corporate reporting. Zydus reports broader U.S. pharmaceutical performance and product-level information selectively, but QMIIZ ODT is not generally presented as a material standalone driver in published financial statements.[4]

Financial assessment

Metric	Public assessment
Standalone revenue	Not separately disclosed
Revenue growth rate	Not publicly established
Gross margin	Not separately disclosed
U.S. market share	Not publicly established
Major milestone sales	No publicly reported blockbuster milestone
Primary value driver	Differentiated formulation and niche prescribing
Primary downside	Generic meloxicam substitution

The likely trajectory is a modest or niche commercial profile rather than a rapid-growth product. Early sales would depend on launch execution, sales-force support, payer placement, and the ability to identify patients who benefit from an orally disintegrating formulation. Over time, price pressure would increase as prescribers and payers compare QMIIZ ODT with generic meloxicam tablets.

A favorable scenario would involve formulary coverage, specialty pharmacy distribution, and adoption in patients with dysphagia or medication-administration barriers. A weaker scenario would involve restricted coverage and substitution to generic tablets at the pharmacy counter.

What generic launch risks exist for QMIIZ ODT?

Generic entry risk is structurally high even without a direct QMIIZ ODT copy.

Direct generic risk

An ANDA applicant could seek approval for an orally disintegrating meloxicam product and challenge any listed formulation patents. A successful Paragraph IV challenge could support earlier entry.

Indirect substitution risk

This is the larger risk. Generic meloxicam tablets and capsules are already available and can replace QMIIZ ODT without infringing a formulation patent. Payers may require generic meloxicam first, and pharmacies may substitute lower-cost products where allowed.

Launch scenarios

Scenario	Expected effect
No direct ODT generic, weak reimbursement	Niche sales with limited pricing power
Direct ODT generic approval	Rapid price erosion and loss of premium
Broad formulary access	Higher prescription volume and improved persistence
Narrow specialty coverage	Concentrated sales in selected patients
Strong prescriber adoption	Better commercial durability despite generic alternatives

What licensing deals affect QMIIZ ODT?

No major publicly disclosed licensing transaction has established QMIIZ ODT as a separately monetized asset. Zydus appears to control the U.S. commercial product through its pharmaceutical operations rather than through a widely reported third-party commercialization agreement.

That structure limits visibility into product-level economics. It also means that any value transfer would likely occur inside Zydus’ broader portfolio, including manufacturing, distribution, sales, and corporate overhead.

What litigation affects QMIIZ ODT?

No widely reported litigation has made QMIIZ ODT a major Hatch-Waxman battleground. The litigation profile is materially lower than for high-revenue drugs with extensive Orange Book patent thickets.

Potential disputes would most likely involve:

• Validity of formulation patents.
• Infringement of orally disintegrating tablet claims.
• FDA approval timing for an ANDA.
• Settlement terms involving generic entry.
• Trade dress or trademark issues involving the QMIIZ name.

The absence of major reported litigation reduces near-term launch disruption risk but also indicates limited evidence of a strong, high-value exclusionary position.

How does QMIIZ ODT compare with generic meloxicam?

Factor	QMIIZ ODT	Generic meloxicam tablets
Active ingredient	Meloxicam	Meloxicam
Dosage form	Orally disintegrating tablet	Conventional tablet or capsule
Patient convenience	Higher for swallowing difficulty	Standard
Price	Generally higher	Low
Formulation differentiation	Yes	Limited
Payer pressure	High	Low
Patent dependence	Formulation-focused	Mature generic market
Commercial scale potential	Niche	Broad volume market

QMIIZ ODT can win selected patients, but it is unlikely to displace generic meloxicam across the full osteoarthritis market without a clear reimbursement or adherence advantage.

What is the investment and licensing outlook for QMIIZ ODT?

QMIIZ ODT is better characterized as a tactical lifecycle product than as a platform asset. Its value could be attractive in a focused portfolio of differentiated oral formulations, especially where the buyer has:

• Existing primary-care or pain prescriber access.
• Specialty pharmacy capabilities.
• Contracting strength with commercial payers.
• Low-cost manufacturing for orally disintegrating tablets.
• A strategy focused on adherence and administration convenience.

The asset is less attractive to a buyer seeking long-term patent exclusivity, high barriers to generic substitution, or transparent product-level revenue growth.

Key Takeaways

• QMIIZ ODT is a 7.5-mg and 15-mg orally disintegrating meloxicam product approved for osteoarthritis pain.
• Its main differentiation is dosage-form convenience, not a new active ingredient.
• Generic meloxicam tablets create substantial indirect substitution risk.
• Any patent value is likely concentrated in formulation, manufacturing, and method-of-use claims.
• No major publicly reported Paragraph IV litigation has established a significant market barrier.
• Zydus does not separately disclose QMIIZ ODT revenue, preventing a verified product-level growth or profitability calculation.
• The commercial outlook is niche and reimbursement-sensitive.
• The product is more relevant as a lifecycle-management or specialty formulation asset than as a high-value exclusivity franchise.

FAQs

Is QMIIZ ODT the same drug as meloxicam?

Yes. QMIIZ ODT contains meloxicam. The difference is its orally disintegrating tablet formulation.

Can a pharmacy substitute generic meloxicam for QMIIZ ODT?

Substitution depends on the product approved, state law, payer rules, and prescription instructions. Generic meloxicam is a therapeutic and economic substitute, but it may not be pharmaceutically identical to the orally disintegrating formulation.

Is QMIIZ ODT protected by a new chemical entity patent?

No. Meloxicam predates QMIIZ ODT by many years. Any exclusivity is associated with the formulation, regulatory approval, or related intellectual property rather than the active ingredient itself.

Does QMIIZ ODT have biosimilar competition?

No. QMIIZ ODT is a small-molecule drug, not a biologic. Its competitive exposure is to generics and other NSAIDs.

Could QMIIZ ODT become a major revenue product for Zydus?

That is unlikely based on its product profile and the absence of separately reported material revenue. It could generate targeted specialty sales, but generic meloxicam and broad NSAID competition constrain its ceiling.

References

1. U.S. Food and Drug Administration. (2019). QMIIZ ODT (meloxicam) orally disintegrating tablets prescribing information.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (n.d.). ANDA submissions: Amendments and requests for final approval to tentatively approved ANDAs.
4. Zydus Lifesciences Limited. (2024). Annual report 2023-24.