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Last Updated: December 7, 2023

Meloxicam - Generic Drug Details


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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.

Drug Prices for meloxicam

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Drug Sales Revenue Trends for meloxicam

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Recent Clinical Trials for meloxicam

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

SponsorPhase
TriHealth Inc.Phase 3
Baptist Health South FloridaPhase 4
InnovaGyn, Inc.Phase 2

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Pharmacology for meloxicam
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane MELOXICAM meloxicam TABLET;ORAL 077925-002 Jul 19, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Puracap Pharm MELOXICAM meloxicam TABLET;ORAL 077938-002 Jul 19, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sciegen Pharms Inc MELOXICAM meloxicam TABLET;ORAL 077920-001 Jul 19, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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) ⤷  Try a Trial
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) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2015191595 ⤷  Try a Trial
Hungary E032426 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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