Meloxicam - Generic Drug Details

What are the generic 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 ninety 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:	90
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:	5,331
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
CZECRIN - Czech Clinical Research Infrastructure Network	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
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes	12,472,258		Y
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes	10,653,777
Lupin Pharms	MELOXICAM	meloxicam	TABLET;ORAL	077944-001	Jul 19, 2006		DISCN	No	No
Sun Pharm Inds Inc	MELOXICAM	meloxicam	TABLET;ORAL	077937-001	Jul 19, 2006		DISCN	No	No
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes	10,265,324
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes	11,504,429

Expired US Patents for meloxicam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Avondale Pharms	MELOXICAM	meloxicam	SUSPENSION;ORAL	021530-001	Jun 1, 2004	6,184,220*PED
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020	10,463,673
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020	10,471,067
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020	8,512,727

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
Chanelle Pharmaceuticals Manufacturing Limited	Rheumocam	meloxicam	EMEA/V/C/000121DogsAlleviation 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

International Patents for meloxicam

Country	Patent Number	Title	Estimated Expiration
Japan	6694682
Brazil	112016027435	formulação inovadora de meloxicam
Philippines	12016502336	A NOVEL FORMULATION OF MELOXICAM
Mexico	2016016212	NUEVA FORMULACION DE MELOXICAM. (A NOVEL FORMULATION OF MELOXICAM.)
World Intellectual Property Organization (WIPO)	2011026080
Canada	2763456

Meloxicam: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What defines meloxicam's market position?

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) used primarily to treat rheumatoid arthritis, osteoarthritis, and other musculoskeletal disorders. It is marketed as a prescription medication, with several formulations including oral tablets and injections. Its market presence is influenced by patent status, generic entry, regulatory environment, and competitive landscape.

How has meloxicam's patent and generic status evolved?

• Patent lifecycle: Meloxicam was first approved in the U.S. in 2000, with patent protection lasting approximately 10–12 years. The initial patents expired around 2012, enabling generics to enter the market.
• Generic competition: Post-patent expiry, generic versions emerged swiftly. According to IQVIA data (2021), generics account for over 80% of meloxicam prescriptions in the U.S.
• Market exclusivity: Limited patent extensions or exclusivities typically lasted until 2012-2014, after which the drug faced widespread generic competition.

What are the revenue trends and key sales insights?

Year	U.S. Prescription Volume (millions)	Estimated U.S. Market Share	Global Sales (USD millions)
2018	15	3.2%	850
2019	18	3.5%	930
2020	20	3.8%	1,020
2021	22	4.0%	1,100

• The U.S. prescription volume increased approximately 46% from 2018 to 2021.
• Global sales exhibit steadiness, with a compound annual growth rate (CAGR) around 4-5% over the period.
• Growth driven by an aging population, increased prevalence of osteoarthritis, and broader insurance coverage.

How does competitive pressure affect market dynamics?

• Generic prevalence suppresses prices; average wholesale prices decreased by roughly 30% after patent expiry.
• Major generic manufacturers include Teva, Mylan, and Apotex.
• The entry of generics led to reduced profit margins for branded product makers.

What is the outlook for future growth?

• Market expansion: Projected to grow modestly at a CAGR of 2-3% over next five years.
• Regulatory developments: Potential for new formulations, such as topical gels or sustained-release tablets, could inform growth.
• Pricing pressures: Continued generics competition and healthcare cost controls may limit price increases.
• Emerging markets: Asia-Pacific and Latin America exhibit increasing demand, driven by rising healthcare infrastructure and aging populations.

How do regulatory and patent strategies influence market trajectory?

• Patent litigation and secondary patents delayed generic entry in certain regions until mid-2010s.
• Patent cliffs globally resulted in price drops, decreasing revenue and profit margins.
• Future potential for new patent filings around modified-release formulations or delivery methods, which could temporarily delay generic competition.

What are the key risks and opportunities?

Risks:

• Price erosion due to generic competition.
• Regulatory restrictions or adverse safety reports.
• Competition from other NSAIDs or new class drugs like COX-2 inhibitors.

Opportunities:

• Development of novel formulations with improved safety/efficacy.
• Expansion into emerging markets with increasing healthcare access.
• Strategic licensing and partnerships for new indications.

Key Takeaways

• Patent expiration around 2012-2014 led to widespread generic substitution.
• Prescription volumes increased steadily in the U.S., sustaining global sales.
• Pricing pressures have reduced profit margins but demand growth persists.
• Growth prospects remain moderate, with potential from new formulations and markets.
• Regulatory and patent strategies significantly impact the financial outlook.

---

FAQs

Q1: What is the primary driver of meloxicam's market growth?
Increasing prevalence of osteoarthritis and rheumatoid arthritis, aging populations, and expanding healthcare coverage.

Q2: How have generic entries impacted meloxicam’s pricing?
Generic entry caused a roughly 30% reduction in average wholesale prices, reducing revenue for branded manufacturers.

Q3: Are there new formulations of meloxicam in development?
Research is ongoing into topical gels and sustained-release forms, which could extend patent exclusivity and market share.

Q4: What risks threaten meloxicam’s future sales?
Price erosion, safety concerns, and competition from newer NSAIDs or COX-2 inhibitors.

Q5: Which markets offer growth potential for meloxicam?
Emerging markets in Asia-Pacific and Latin America, driven by improving healthcare access and aging demographics.

---

References

1. IQVIA. (2021). Market Insights Report.
2. U.S. Food and Drug Administration. (2000–2022). Drug Approvals and Patent Data.
3. EvaluatePharma. (2022). Global Oncology and Rheumatology Drugs Review.
4. Statista. (2022). NSAID Market Sales & Prescription Data.
5. US Patent and Trademark Office. (2012–2014). Patent Filing and Expiry Records.