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Last Updated: August 17, 2022

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, Aiping Pharm Inc, Anda Repository, Apotex Inc, Aurobindo Pharma, Cipla, Cr Double Crane, Dr Reddys Labs Inc, Glenmark Generics, Heritage Pharma, Impax Labs Inc, Lupin Pharms, Mylan, Puracap Pharm, Roxane, Strides Pharma, Sun Pharm Inds Inc, Taro, Unichem, Yabao Pharm, Yung Shin Pharm, Zydus Pharms Usa, and Boehringer Ingelheim, and is included in twenty-nine 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-three countries.

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

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SponsorPhase
University of MiamiPhase 3
Mayo ClinicPhase 4
Alfarabi CollegesN/A

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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
Iceutica Operations VIVLODEX meloxicam CAPSULE;ORAL 207233-002 Oct 22, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Baudax ANJESO meloxicam SOLUTION;INTRAVENOUS 210583-001 Feb 20, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Iceutica Operations VIVLODEX meloxicam CAPSULE;ORAL 207233-001 Oct 22, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for MELOXICAM

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2015191595 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2011026080 See Plans and Pricing
European Patent Office 1938803 Formules à méloxicane nanoparticulaire (Formulations comprising nanoparticulate meloxican) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Boehringer Ingelheim
Colorcon
Mallinckrodt
McKesson

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