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, Aiping Pharm Inc, Anda Repository, Ascent Pharms Inc, Aurobindo Pharma, Chartwell Rx, Cipla, Corepharma, Cr Double Crane, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Impax Labs Inc, Lupin Pharms, Mylan, Natco Pharma, 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 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-six suppliers are listed for this compound.
Summary for meloxicam
International Patents: | 64 |
US Patents: | 11 |
Tradenames: | 5 |
Applicants: | 30 |
NDAs: | 30 |
Drug Master File Entries: | 22 |
Finished Product Suppliers / Packagers: | 46 |
Raw Ingredient (Bulk) Api Vendors: | 145 |
Clinical Trials: | 93 |
Patent Applications: | 7,238 |
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 |
---|---|
University of Miami | Phase 4 |
TriHealth Inc. | Phase 3 |
Baptist Health South Florida | Phase 4 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baudax | ANJESO | meloxicam | SOLUTION;INTRAVENOUS | 210583-001 | Feb 20, 2020 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Baudax | ANJESO | meloxicam | SOLUTION;INTRAVENOUS | 210583-001 | Feb 20, 2020 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Cipla | MELOXICAM | meloxicam | TABLET;ORAL | 077929-001 | Jul 19, 2006 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cr Double Crane | MELOXICAM | meloxicam | TABLET;ORAL | 078039-001 | Dec 14, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aiping Pharm Inc | MELOXICAM | meloxicam | TABLET;ORAL | 077920-001 | Jul 19, 2006 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys Labs Inc | MELOXICAM | meloxicam | TABLET;ORAL | 077931-002 | Jul 25, 2006 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Natco Pharma | MELOXICAM | meloxicam | TABLET;ORAL | 077923-001 | Jul 19, 2006 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Avondale Pharms | MELOXICAM | meloxicam | SUSPENSION;ORAL | 021530-001 | Jun 1, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Baudax | ANJESO | meloxicam | SOLUTION;INTRAVENOUS | 210583-001 | Feb 20, 2020 | ⤷ Sign Up | ⤷ Sign Up |
Baudax | ANJESO | meloxicam | SOLUTION;INTRAVENOUS | 210583-001 | Feb 20, 2020 | ⤷ Sign Up | ⤷ Sign Up |
>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 | |
Chanelle Pharmaceuticals Manufacturing Limited | Rheumocam | meloxicam | EMEA/V/C/000121 DogsAlleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs. To reduce post-operative pain and inflammation following orthopaedic and soft tissue surgery.CatsReduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.Alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.CattleFor 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 adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.PigsFor use in non-infectious 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. For the relief of post operative pain associated with minor soft tissue such as castration.HorsesAlleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses..For the relief of pain associated with equine colic. |
Authorised | yes | no | no | 2008-01-10 | |
Emdoka bvba | Emdocam | meloxicam | EMEA/V/C/002283 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 adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitits-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.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.Cats:Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery. |
Authorised | yes | no | no | 2011-08-18 | |
>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) | 2011026080 | ⤷ Sign Up | |
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) | ⤷ Sign Up |
China | 107073010 | 新型美洛昔康制剂 (A novel formulation of meloxicam) | ⤷ Sign Up |
Spain | 2701673 | ⤷ Sign Up | |
New Zealand | 726610 | A novel formulation of meloxicam | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2005002542 | ⤷ Sign Up | |
Singapore | 11201610179Q | A NOVEL FORMULATION OF MELOXICAM | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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