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

Meloxicam has sixty-five patent family members in twenty-three countries.

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

Summary for meloxicam

International Patents:	65
US Patents:	11
Tradenames:	5
Applicants:	29
NDAs:	30
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	145
Clinical Trials:	92
Patent Applications:	7,162
Formulation / Manufacturing:	see details
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
TriHealth Inc.	Phase 3
Baptist Health South Florida	Phase 4
InnovaGyn, Inc.	Phase 2

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
Roxane	MELOXICAM	meloxicam	TABLET;ORAL	077925-001	Jul 19, 2006		DISCN	No	No
Roxane	MELOXICAM	meloxicam	TABLET;ORAL	077925-002	Jul 19, 2006		DISCN	No	No
Puracap Pharm	MELOXICAM	meloxicam	TABLET;ORAL	077938-002	Jul 19, 2006	AB	RX	No	No
Sciegen Pharms Inc	MELOXICAM	meloxicam	TABLET;ORAL	077920-001	Jul 19, 2006		DISCN	No	No

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
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
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.	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
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
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

International Patents for meloxicam

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3167875	RÉDUCTION D'AGRÉGATION DE TYPE PAILLETTES DANS DES COMPOSITIONS DE MELOXICAM NANOPARTICULAIRE (REDUCTION OF FLAKE-LIKE AGGREGATION IN NANOPARTICULATE MELOXICAM COMPOSITIONS)
European Patent Office	3761977	MÉTHODES D'ADMINISTRATION DE MELOXICAM PAR VOIE INTRAVEINEUSE EN UNE DOSE BOLUS (METHODS OF ADMINISTERING INTRAVENOUS MELOXICAM IN A BOLUS DOSE)
World Intellectual Property Organization (WIPO)	2015191595
Hungary	E032426