MELOXICAM - Generic Drug Details

What are the generic drug sources for meloxicam and what is the scope of patent protection?

Meloxicam is the generic ingredient in eight branded drugs marketed by Lupin Ltd, Novitium Pharma, Iceutica Operations, Baudax, Nanjing Delova, Azurity, Avondale Pharms, Tersera, Aiping Pharm Inc, Ascent Pharms Inc, Aurobindo Pharma, Chartwell Rx, Cipla, Corepharma, Cr Double Crane, Glenmark Pharms Ltd, Impax Labs Inc, Lupin Pharms, Mylan, Natco Pharma, Puracap Pharm, Rising, Roxane, Sun Pharm Inds Inc, Taro, Tp Anda Holdings, Unichem, Yabao Pharm, Yung Shin Pharm, Zydus Pharms Usa, Boehringer Ingelheim, and Axsome, and is included in thirty-three NDAs. There are eighty-six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Meloxicam has seventy-three patent family members in twenty-two countries.

There are twenty-two drug master file entries for meloxicam. Forty-four suppliers are listed for this compound.

Summary for MELOXICAM

International Patents:	73
US Patents:	86
Tradenames:	8
Applicants:	32
NDAs:	33
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	104
Patent Applications:	5,244
Drug Prices:	Drug price trends for MELOXICAM
Drug Sales Revenues:	Drug sales revenues for MELOXICAM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MELOXICAM
What excipients (inactive ingredients) are in MELOXICAM?	MELOXICAM excipients list
DailyMed Link:	MELOXICAM at DailyMed

See drug prices for MELOXICAM

See drug sales revenues for MELOXICAM

Recent Clinical Trials for MELOXICAM

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

Sponsor	Phase
University of Oklahoma	PHASE4
St. Louis University	PHASE4
Masaryk University	PHASE2

See all MELOXICAM clinical trials

Pharmacology for MELOXICAM

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

Anatomical Therapeutic Chemical (ATC) Classes for MELOXICAM

M01AC	Oxicams
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

Paragraph IV (Patent) Challenges for MELOXICAM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIVLODEX	Capsules	meloxicam	5 mg and 10 mg	207233	1	2017-01-09
MELOXICAM	Oral Suspension	meloxicam	7.5 mg/5 mL	021530	1	2009-12-17

US Patents and Regulatory Information for MELOXICAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avondale Pharms	MELOXICAM	meloxicam	SUSPENSION;ORAL	021530-001	Jun 1, 2004		RX	Yes	Yes
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes

Expired US Patents for MELOXICAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020
Avondale Pharms	MELOXICAM	meloxicam	SUSPENSION;ORAL	021530-001	Jun 1, 2004
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020

EU/EMA Drug Approvals for MELOXICAM

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 MELOXICAM

Country	Patent Number	Title	Estimated Expiration
Japan	2012012397	NANOPARTICULATE MELOXICAM FORMULATION
World Intellectual Property Organization (WIPO)	2011026080
Japan	2022505572
European Patent Office	2435027	RÉDUCTION DES AGRÉGATS SOUS FORME DE PAILLETTES DANS DES COMPOSITIONS NANOPARTICULAIRES DE MÉLOXICAM (REDUCTION OF FLAKE-LIKE AGGREGATION IN NANOPARTICULATE MELOXICAM COMPOSITIONS)
Japan	2021527697	ボーラス用量での経静脈メロキシカムの投与方法

Market Dynamics and Financial Trajectory for Meloxicam

Last updated: July 27, 2025

Introduction

Meloxicam, a potent nonsteroidal anti-inflammatory drug (NSAID), has established itself as a key player in managing osteoarthritis, rheumatoid arthritis, and other musculoskeletal disorders. Its unique pharmacokinetic profile, characterized by a preferential COX-2 inhibition, offers an improved safety profile compared to traditional NSAIDs, fostering widespread acceptance among clinicians and patients. This article examines the evolving market dynamics, competitive landscape, regulatory factors, and financial trajectory shaping meloxicam’s future growth potential.

Market Overview and Demand Drivers

Global Market Size and Growth Trajectory

The global NSAID market, estimated at USD 22.6 billion in 2022, is projected to demonstrate a compounded annual growth rate (CAGR) of approximately 4.2% from 2023 to 2030 (reference: Grand View Research). Meloxicam's share of this market has benefited from its favorable safety profile, preferred by clinicians for long-term use in chronic conditions. Its prominence is reinforced by the rising prevalence of osteoarthritis and rheumatoid arthritis globally; the World Health Organization estimates that osteoarthritis affects over 300 million people worldwide.[1]

Key Drivers

• Aging Population: An increase in elderly demographics, especially in North America, Europe, and parts of Asia, fuels demand for effective, long-term anti-inflammatory therapy.
• Chronic Disease Burden: The surge in chronic musculoskeletal disorders necessitates sustained therapy options like meloxicam.
• Prescription Trends: Clinicians increasingly favor selective COX-2 inhibitors like meloxicam due to reduced gastrointestinal side effects compared to traditional NSAIDs.
• Regulatory Support: Solid safety data and positive post-marketing surveillance reinforce regulatory confidence and formulary inclusion, expanding access.

Therapeutic Shifts and Prescribing Patterns

While traditional NSAIDs remain broadly used, advances in understanding NSAIDs’ safety profiles have shifted prescribing patterns toward drugs with a COX-2 selectivity, such as meloxicam. The increased emphasis on minimizing gastrointestinal and cardiovascular adverse effects has bolstered its market position, especially within markets favoring long-term therapy.

Market Competition and Patent Landscape

Generic and Branded Competition

Most formulations of meloxicam are off-patent or facing patent expiry, resulting in a highly competitive generics market. Leading pharmaceuticals like Mylan, Teva, and Apotex offer generic versions, which significantly pressure pricing and margins.[2] Despite this, branded versions—such as Mobic (by Boehringer Ingelheim)—maintain strong market presence in certain regions due to brand recognition and physician preference.

Emerging Competitors and Novel Therapies

The NSAID spectrum faces increasing competition from biologics and targeted therapies for inflammatory conditions, such as interleukin inhibitors. Moreover, non-NSAID pain management options, including opioids and other analgesics, influence prescribing dynamics. Nevertheless, the safety profile of meloxicam sustains its role, especially where long-term anti-inflammatory therapy is requisite.

Regulatory Considerations

Patent expiries aren't significant hurdles for meloxicam’s formulations, but regulatory scrutiny over cardiovascular risks associated with NSAIDs persists. The FDA and EMA endorse cautionary labeling, which influences clinician choice and insurance coverage decisions.

Regulatory and Safety Landscape

Post-Marketing Surveillance

Safety monitoring indicates that, although meloxicam exhibits a relatively safer gastrointestinal profile, cardiovascular risks remain, similar to other NSAIDs. The FDA issued advisories linking NSAID use with increased heart attack and stroke risk, leading to more conservative prescribing practices in certain patient populations.[3]

Impact on Market Dynamics

Regulatory warnings and safety advisories influence formulary decisions and clinician prescribing behavior, fostering a cautious but sustained demand. This underscores the importance of patient-specific risk assessment and education to optimize therapeutic outcomes and maintain market stability.

Financial Trajectory and Revenue Outlook

Revenue Patterns and Regional Performance

In the United States, Meloxicam ranks among top-selling NSAIDs, with annual sales surpassing USD 400 million for branded products alone. The generics market further amplifies volume sales, although with compressed margins. Asia-Pacific and Latin America represent high-growth territories driven by increasing healthcare access and the rising prevalence of chronic inflammatory diseases.

Forecast and Growth Opportunities

Analysts project a steady CAGR of 3–4% in meloxicam’s global sales over the next five years, primarily driven by:

• Market expansion in emerging economies owing to increased healthcare infrastructure investment.
• Formulary inclusion in developing health insurance schemes.
• Increased awareness about meloxicam’s safety profile, shifting clinicians away from traditional NSAIDs.

However, prices may experience further compression owing to aging patent rights, intensified generic competition, and cost-control measures.

Strategic Growth Pathways

Pharmaceutical companies are exploring formulations with extended-release profiles to improve patient compliance and dosing convenience, creating potential premium products. Additionally, combination therapies involving meloxicam with other agents, such as gastroprotective drugs, could command higher pricing and market share.

Market Challenges and Risks

• Safety Concerns: Cardiovascular risks associated with NSAIDs exert pressure on prescribing and market growth.
• Pricing Pressures: Intense competition and healthcare cost containment result in downward pricing trends.
• Regulatory Hurdles: Stricter safety regulations may delay market access for formulations with improved profiles.
• Patent Expiry: Accelerates generic competition, impacting revenue streams for branded drugs.

Future Outlook and Strategic Recommendations

To sustain growth, stakeholders should invest in:

• Enhancing formulations with improved safety and convenience features.
• Expanding presence in emerging markets through strategic licensing.
• Conducting real-world safety studies to reinforce credibility.
• Developing combination therapies to foster differentiation.

Key Takeaways

• Consistent Demand: The aging population and rising chronic disease burden ensure steady demand for meloxicam, especially in long-term inflammatory disease management.
• Competitive Landscape: Generics dominate, exerting price pressure, but branded versions retain loyalty due to brand trust and minor efficacy advantages.
• Safety and Regulation: Cardiovascular risk management remains central; regulatory advisories influence prescribing trends and market access strategies.
• Revenue Stability: While global sales are projected to grow modestly (3–4% CAGR), expanding markets and formulation innovations present avenues for revenue enhancement.
• Market Risks: Intensified competition, regulatory hurdles, and safety concerns necessitate proactive strategic planning by manufacturers.

FAQs

1. What factors influence meloxicam’s market growth?
Key factors include the global rise in arthritis-related conditions, aging populations, clinician preference for COX-2 selectivity, and expanding healthcare access in emerging economies.

2. How does patent expiry impact meloxicam’s market?
Most formulations are off-patent, leading to increased generic competition, lower prices, and thinner profit margins for branded manufacturers.

3. Are safety concerns affecting meloxicam’s market stability?
Yes. Cardiovascular risks associated with NSAIDs, including meloxicam, influence prescribing behaviors and regulatory advisories, which can temper market growth.

4. What opportunities exist for future revenue enhancement?
Formulation innovations, expanding into emerging markets, developing combination therapies, and improving safety profiles offer growth avenues.

5. How do regulatory frameworks shape meloxicam’s market trajectory?
Regulatory agencies’ safety warnings and labeling influence prescribing practices, formulary decisions, and overall market access, impacting revenue prospects.

References

1. Grand View Research. (2022). NSAID Market Size, Share & Trends Analysis Report.
2. Pharmaceutical Technology. (2021). The Competitive Landscape of Meloxicam Generics.
3. FDA. (2020). NSAID Drug Safety Communication.
4. World Health Organization. (2019). Osteoarthritis Prevalence Report.
5. Bloomberg Intelligence. (2022). Market Outlook for NSAIDs.

This comprehensive analysis provides actionable insights for professionals navigating the complexities of the meloxicam market, emphasizing planning in response to evolving demands, competition, regulatory environment, and safety considerations.