VIVLODEX Drug Patent Profile

Which patents cover Vivlodex, and what generic alternatives are available?

Vivlodex is a drug marketed by Iceutica Operations and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in sixteen countries.

The generic ingredient in VIVLODEX is meloxicam. There are twenty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the meloxicam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vivlodex

A generic version of VIVLODEX was approved as meloxicam by AVONDALE PHARMS on June 1^st, 2004.

Summary for VIVLODEX

International Patents:	16
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	145
Patent Applications:	2,932
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VIVLODEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIVLODEX
What excipients (inactive ingredients) are in VIVLODEX?	VIVLODEX excipients list
DailyMed Link:	VIVLODEX at DailyMed

See drug prices for VIVLODEX

See drug sales revenues for VIVLODEX

Anatomical Therapeutic Chemical (ATC) Classes for VIVLODEX

M01AC	Oxicams
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

Paragraph IV (Patent) Challenges for VIVLODEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIVLODEX	Capsules	meloxicam	5 mg and 10 mg	207233	1	2017-01-09

US Patents and Regulatory Information for VIVLODEX

VIVLODEX is protected by four US patents.

Patents protecting VIVLODEX

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	207233-001	Oct 22, 2015		DISCN	Yes	No
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-002	Oct 22, 2015		DISCN	Yes	No			Y
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-001	Oct 22, 2015		DISCN	Yes	No			Y
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-002	Oct 22, 2015		DISCN	Yes	No			Y
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-001	Oct 22, 2015		DISCN	Yes	No			Y
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-002	Oct 22, 2015		DISCN	Yes	No

EU/EMA Drug Approvals for VIVLODEX

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

International Patents for VIVLODEX

See the table below for patents covering VIVLODEX around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20170017915	멜록시캄의 신규 제형 (A NOVEL FORMULATION OF MELOXICAM)
Philippines	12016502336	A NOVEL FORMULATION OF MELOXICAM
New Zealand	726610	A novel formulation of meloxicam
Japan	2017517551	メロキシカムの新規製剤
Morocco	39443	Nouvelle formulation de méloxicam
Australia	2015274838	A novel formulation of meloxicam
China	107073010	新型美洛昔康制剂 (A novel formulation of meloxicam)