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Last Updated: March 29, 2024

Meloxicam - Generic Drug Details


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What are the generic drug 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-four patent family members in twenty-two countries.

There are twenty-two drug master file entries for meloxicam. Forty-seven 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

See all meloxicam clinical trials

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
Baudax ANJESO meloxicam SOLUTION;INTRAVENOUS 210583-001 Feb 20, 2020 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Corepharma MELOXICAM meloxicam TABLET;ORAL 077882-001 Jul 20, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Baudax ANJESO meloxicam SOLUTION;INTRAVENOUS 210583-001 Feb 20, 2020 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Aurobindo Pharma MELOXICAM meloxicam TABLET;ORAL 078008-001 Oct 2, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Iceutica Operations VIVLODEX meloxicam CAPSULE;ORAL 207233-002 Oct 22, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

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 ⤷  Try a Trial ⤷  Try a Trial
Avondale Pharms MELOXICAM meloxicam SUSPENSION;ORAL 021530-001 Jun 1, 2004 ⤷  Try a Trial ⤷  Try a Trial
Baudax ANJESO meloxicam SOLUTION;INTRAVENOUS 210583-001 Feb 20, 2020 ⤷  Try a Trial ⤷  Try a Trial
Baudax ANJESO meloxicam SOLUTION;INTRAVENOUS 210583-001 Feb 20, 2020 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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
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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for meloxicam

Country Patent Number Title Estimated Expiration
Japan 2011042670 NANOPARTICULATE MELOXICAM FORMULATION ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2019173715 ⤷  Try a Trial
Canada 2951383 NOUVELLE FORMULATION DE MELOXICAM (A NOVEL FORMULATION OF MELOXICAM) ⤷  Try a Trial
Japan 6072539 ⤷  Try a Trial
Australia 2015274838 A novel formulation of meloxicam ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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