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.
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 |
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 |
Pharmacology for meloxicam
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for meloxicam
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 |
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 |
>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 | |
>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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