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

Meloxicam has sixty-four patent family members in twenty-two countries.

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

Summary for MELOXICAM

International Patents:	64
US Patents:	9
Tradenames:	6
Applicants:	31
NDAs:	31
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	145
Clinical Trials:	93
Patent Applications:	7,286
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 Miami	Phase 4
TriHealth Inc.	Phase 3
Baptist Health South Florida	Phase 4

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
Boehringer Ingelheim	MOBIC	meloxicam	TABLET;ORAL	020938-001	Apr 13, 2000		DISCN	Yes	No
Boehringer Ingelheim	MOBIC	meloxicam	TABLET;ORAL	020938-002	Aug 23, 2000		DISCN	Yes	No
Natco Pharma	MELOXICAM	meloxicam	TABLET;ORAL	077923-002	Jul 19, 2006		DISCN	No	No
Lupin Pharms	MELOXICAM	meloxicam	TABLET;ORAL	077944-001	Jul 19, 2006	AB	RX	No	No
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
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020
Avondale Pharms	MELOXICAM	meloxicam	SUSPENSION;ORAL	021530-001	Jun 1, 2004

EU/EMA Drug Approvals for MELOXICAM

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
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
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 MELOXICAM

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3151835	NOUVELLE FORMULATION DE MÉLOXICAM (A NOVEL FORMULATION OF MELOXICAM)
European Patent Office	3870163
Japan	2021527697
Japan	2022505572
Japan	2016053028

Market Dynamics and Financial Trajectory for Meloxicam

Introduction

Meloxicam, a nonsteroidal anti-inflammatory drug (NSAID) and a selective COX-2 inhibitor, is widely used for the treatment of various forms of arthritis, including osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis. The market for meloxicam is experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The global meloxicam market is anticipated to expand substantially over the coming years. By 2036, the market size is expected to reach USD 47 billion, growing at a Compound Annual Growth Rate (CAGR) of around 5% from 2024 to 2036. In 2023, the market size was over USD 7 billion[1][4].

Growth Drivers

Increasing Prevalence of Arthritis

The rising incidence of osteoarthritis, rheumatoid arthritis, and other chronic pain conditions, particularly among the aging population, is a major driver of the meloxicam market. According to the World Health Organization, 60% of those with osteoarthritis are female, and 73% are older than 55 years. The knee is the most frequently affected joint, with an estimated 365 million cases worldwide[1].

Awareness and Availability of Pain Relief Medication

Increased awareness about the availability of pain relief medications has also contributed to the market growth. The population is becoming more informed about treatment options, which is boosting the demand for meloxicam[1].

Combination Drugs

The market for combination drugs, which include meloxicam, is set to grow significantly. For example, ZYNRELEF, a combination of bupivacaine and meloxicam, has seen increased sales due to its effectiveness in treating multiple conditions simultaneously[2].

Market Segmentation

By Disease

The osteoarthritis segment is expected to account for the largest revenue share, approximately 40% by the end of 2036. This is due to the high prevalence of osteoarthritis and the use of meloxicam as a preferred treatment option[1].

By Drug Type

The market is segmented into generic and branded drugs. The generic segment is expected to grow significantly due to its cost-effectiveness and wider availability[4].

By Population Type

Meloxicam is used across various population types, including adults and children. The adult segment dominates the market due to the higher incidence of arthritis among this demographic[4].

By Dosage and Dose Strength

Meloxicam is available in various dosages, including oral, parenteral, and transdermal forms. The oral dosage form is the most common, with dose strengths of 7.5mg and 15mg being widely prescribed[4].

Regional Market Analysis

North America

The North American region is anticipated to account for the largest revenue share, approximately 33% by the end of the forecast period. This growth is driven by the increasing number of arthritis patients and the robust healthcare infrastructure in the region. According to the National Health Interview Survey, an estimated 58.5 million US adults have been diagnosed with some form of arthritis[1].

Asia Pacific

The Asia Pacific region is expected to see significant growth due to the increasing aging population and the rising incidence of osteoarthritis and rheumatoid arthritis. Favorable reimbursement policies for generic drugs in this region are also driving market growth[1].

Financial Performance and Trends

Revenue Growth

Companies like Heron Therapeutics, which markets ZYNRELEF, have seen positive revenue growth. In 2023, ZYNRELEF achieved a quarterly record of $5.6 million in net product sales, with full-year sales reaching $17.7 million. This indicates a growing demand for meloxicam-based products[2].

Cost Efficiency

Studies have shown that meloxicam is a cost-efficient treatment option compared to other NSAIDs. An economic evaluation revealed that meloxicam had the lowest cost per patient, resulting in significant cost savings for healthcare systems[5].

Challenges and Limitations

Side Effects

Despite its benefits, meloxicam is associated with side effects such as ulcers, dizziness, and other gastrointestinal issues. These side effects can hamper market growth and necessitate careful patient monitoring[4].

Market Competition

The meloxicam market faces competition from other pain management medications, including opioids and other NSAIDs. However, the preference for NSAIDs over opioids due to their lower risk of addiction is a positive trend for meloxicam[4].

Key Takeaways

• The global meloxicam market is projected to reach USD 47 billion by 2036, driven by the increasing prevalence of arthritis and chronic pain conditions.
• The North American and Asia Pacific regions are expected to be significant contributors to market growth.
• Combination drugs like ZYNRELEF are gaining traction due to their multi-condition treatment capabilities.
• Meloxicam is a cost-efficient treatment option compared to other NSAIDs.
• Side effects and market competition are key challenges that need to be addressed.

FAQs

What is the projected market size of meloxicam by 2036?

The global meloxicam market is anticipated to reach USD 47 billion by the end of 2036[1].

Which region is expected to account for the largest revenue share in the meloxicam market?

The North American region is expected to account for the largest revenue share, approximately 33% by the end of the forecast period[1].

What are the primary growth drivers for the meloxicam market?

The primary growth drivers include the increasing prevalence of osteoarthritis, rheumatoid arthritis, and other chronic pain conditions, as well as increased awareness about pain relief medications[1].

What are the common side effects associated with meloxicam?

Common side effects include ulcers, dizziness, and other gastrointestinal issues[4].

How does meloxicam compare to other NSAIDs in terms of cost efficiency?

Meloxicam is predicted to be the lowest cost drug therapy compared to nonselective NSAIDs like diclofenac and piroxicam, resulting in significant cost savings for healthcare systems[5].

Sources:

1. Research Nester, Meloxicam Market Size - Global Forecast Report 2036, November 2, 2023.
2. Heron Therapeutics, Heron Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results and Highlights Recent Corporate Updates, March 12, 2024.
3. Market Research Intellect, Meloxicam Drug Sales: Insights into Growth Trends and Market Evolution, October 1, 2024.
4. Data Bridge Market Research, Global Meloxicam Market - Industry Trends and Forecast to 2028.
5. PubMed, An economic evaluation of meloxicam versus diclofenac and piroxicam.