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-two 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:	146
Patent Applications:	4,032
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
Boehringer Ingelheim Vetmedica GmbH	Metacam	meloxicam	EMEA/V/C/000033 Cats: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
Boehringer Ingelheim Vetmedica GmbH	Novem	meloxicam	EMEA/V/C/000086 Novem 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
Chanelle Pharmaceuticals Manufacturing Limited	Rheumocam	meloxicam	EMEA/V/C/000121 DogsAlleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs. To reduce post-operative pain and inflammation following orthopaedic and soft tissue surgery.CatsReduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.Alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.CattleFor 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 adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.PigsFor use in non-infectious 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. For the relief of post operative pain associated with minor soft tissue such as castration.HorsesAlleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses..For the relief of pain associated with equine colic.	Authorised	yes	no	no	2008-01-10
Norbrook Laboratories (Ireland) Limited	Loxicom	meloxicam	EMEA/V/C/000141 DogsAlleviation 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
Emdoka bvba	Emdocam	meloxicam	EMEA/V/C/002283 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 adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitits-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.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.Cats:Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.	Authorised	yes	no	no	2011-08-18
Le Vet Beheer B.V	Meloxidolor	meloxicam	EMEA/V/C/002590 DogsAlleviation 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
Le Vet Beheer B.V.	Novaquin	meloxicam	EMEA/V/C/003866 Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.	Authorised	no	no	no	2015-09-08

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 QMIIZ ODT

Introduction

QMIIZ ODT, a brand name for meloxicam, is an orally disintegrating tablet indicated for the relief of symptoms associated with osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis. To understand the market dynamics and financial trajectory of QMIIZ ODT, we need to delve into several key areas, including its approval, market competition, pricing strategies, and the impact of generic availability.

Approval and Market Entry

QMIIZ ODT was approved by the FDA on October 19, 2018, in orally disintegrating tablet formulations of 7.5 mg and 15 mg[4]. This approval marked the entry of another meloxicam formulation into the market, expanding the treatment options for patients with arthritis.

Market Competition

The pharmaceutical market for nonsteroidal anti-inflammatory drugs (NSAIDs) is highly competitive. QMIIZ ODT competes with other meloxicam formulations as well as other NSAIDs. The competitive landscape is further complicated by the presence of generic versions of meloxicam, although the specific formulations of QMIIZ ODT are not interchangeable with other meloxicam products[2].

Pricing Strategies

Pricing for QMIIZ ODT would be influenced by several factors, including the cost of production, market demand, and the pricing of competing products. Given that QMIIZ ODT is a brand-name drug, it is likely priced higher than generic alternatives. However, the unique formulation and convenience of an orally disintegrating tablet may justify a premium price for some patients.

Generic Availability

As of the latest updates, all formulations of QMIIZ ODT have been discontinued[4]. This discontinuation could significantly impact the financial trajectory of the drug. However, it is important to note that generic versions of meloxicam are available, which can fill the gap left by the discontinuation of QMIIZ ODT.

Financial Impact of Discontinuation

The discontinuation of QMIIZ ODT formulations would likely result in a significant decline in revenue for the manufacturer, TERSERA. This decline could be mitigated if the company has other products in its portfolio or if it plans to reintroduce the drug in the future.

Market Demand and Patient Needs

Osteoarthritis and rheumatoid arthritis are prevalent conditions with substantial economic and personal burdens. The economic burden of osteoarthritis alone exceeds $340 billion annually in direct healthcare costs, and indirect costs are even higher[5]. Despite the discontinuation of QMIIZ ODT, the demand for effective treatments for these conditions remains high.

Regulatory and Safety Considerations

QMIIZ ODT, like other NSAIDs, carries significant safety risks, including increased chances of serious cardiovascular and gastrointestinal events[2]. Regulatory bodies closely monitor these risks, and any changes in safety profiles or regulatory requirements could impact the drug's market dynamics.

Innovative Practices and Market Adaptation

The pharmaceutical industry is known for its innovative practices, and companies often adapt to market changes by developing new formulations or indications. The development of follow-on drugs, which can provide needed therapeutic options and inject price competition, is a common strategy[3].

Consumer and Prescriber Preferences

Consumer and prescriber preferences play a crucial role in the market dynamics of any drug. The convenience of an orally disintegrating tablet, for instance, may be a significant factor for patients who have difficulty swallowing traditional tablets. However, with the discontinuation of QMIIZ ODT, these preferences may shift towards other available formulations.

Healthcare System Integration

Integration into healthcare systems, including Medicaid and other insurance programs, is vital for a drug's financial success. For example, Medicaid programs have implemented various strategies to manage prescription drug use, including monitoring opioid and benzodiazepine use, which could indirectly influence the market for NSAIDs like QMIIZ ODT[1].

Future Outlook

Given the discontinuation of QMIIZ ODT, the future outlook for this specific drug is limited. However, the broader market for NSAIDs and arthritis treatments remains robust. Manufacturers may focus on developing new formulations or improving existing ones to meet patient needs and stay competitive.

Key Takeaways

• Approval and Market Entry: QMIIZ ODT was approved in 2018 but has since been discontinued.
• Market Competition: The drug competes in a highly competitive NSAID market.
• Pricing Strategies: Pricing is influenced by production costs, market demand, and competition.
• Generic Availability: Generic meloxicam is available, filling the gap left by QMIIZ ODT.
• Financial Impact: Discontinuation likely resulted in significant revenue decline for the manufacturer.
• Market Demand: High demand for arthritis treatments persists despite QMIIZ ODT's discontinuation.
• Regulatory and Safety Considerations: Close monitoring of safety risks is crucial.
• Innovative Practices: Companies adapt through new formulations and indications.
• Consumer and Prescriber Preferences: Convenience and safety are key factors.

FAQs

1. What is QMIIZ ODT used for? QMIIZ ODT is used for the relief of symptoms associated with osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis.

2. Why was QMIIZ ODT discontinued? The specific reasons for the discontinuation of QMIIZ ODT are not detailed in available sources, but it could be due to various factors including market demand, production costs, or strategic decisions by the manufacturer.

3. Are generic versions of meloxicam available? Yes, generic versions of meloxicam are available, although they are not interchangeable with QMIIZ ODT formulations.

4. What are the safety risks associated with QMIIZ ODT? QMIIZ ODT, like other NSAIDs, carries risks of serious cardiovascular and gastrointestinal events.

5. How does the discontinuation of QMIIZ ODT impact patients? Patients may need to switch to other meloxicam formulations or different NSAIDs, which could affect their treatment plans and preferences.

Cited Sources

1. National Medicaid Fee‐For‐Service (FFS) 2019 Drug Utilization Report[1]
2. RxList - QMIIZ ODT (Meloxicam Orally Disintegrating Tablets)[2]
3. The economics of follow-on drug research and development[3]
4. Generic Qmiiz ODT Availability - Drugs.com[4]
5. VA/DoD CLINICAL PRACTICE GUIDELINE FOR THE NON-SURGICAL MANAGEMENT OF OSTEoARTHRTIS[5]