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-two 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:	3,853
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

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.

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	207233-001	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	207233-002	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
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
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
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
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
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
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
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

International Patents for VIVLODEX

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

Country	Patent Number	Title	Estimated Expiration
Australia	2015274838	A novel formulation of meloxicam
Canada	2951383	NOUVELLE FORMULATION DE MELOXICAM (A NOVEL FORMULATION OF MELOXICAM)
China	107073010	新型美洛昔康制剂 (A novel formulation of meloxicam)
Mexico	2016016212	NUEVA FORMULACION DE MELOXICAM. (A NOVEL FORMULATION OF MELOXICAM.)
Morocco	39443	Nouvelle formulation de méloxicam
Singapore	11201610179Q	A NOVEL FORMULATION OF MELOXICAM
South Korea	20170017915	멜록시캄의 신규 제형 (A NOVEL FORMULATION OF MELOXICAM)

Market Dynamics and Financial Trajectory for VIVLODEX

Introduction to VIVLODEX

VIVLODEX, a low-dose SoluMatrix® nonsteroidal anti-inflammatory drug (NSAID), was approved by the U.S. Food and Drug Administration (FDA) in October 2015 for the management of osteoarthritis pain. It contains meloxicam in a reformulated version with reduced particle size, facilitating faster dissolution and rapid absorption[1][4].

Clinical Efficacy and Market Position

The drug has demonstrated significant clinical efficacy in reducing osteoarthritis pain. A Phase 3 study showed that patients treated with VIVLODEX 5 mg and 10 mg used significantly less rescue medication compared to those receiving a placebo. This reduction in rescue medication use underscores the drug's effectiveness in managing OA pain, positioning it favorably in the market[1].

Market Need and Competition

Osteoarthritis is a prevalent condition, and the demand for effective pain management solutions is high. VIVLODEX fills this need by offering a low-dose NSAID option that aligns with medical guidelines recommending the use of NSAIDs at the lowest effective dosage for the shortest duration. This approach differentiates VIVLODEX from other meloxicam products, such as Mobic, by providing a formulation with faster absorption and potentially fewer side effects[1][4].

Financial Performance and Revenue Potential

While specific financial data for VIVLODEX alone is not readily available, the overall performance of its manufacturer, Iroko Pharmaceuticals, and similar pharmaceutical companies can provide insights. The approval and subsequent marketing of VIVLODEX would likely contribute to the revenue growth of Iroko Pharmaceuticals. Given the drug's unique formulation and clinical benefits, it has the potential to capture a significant share of the osteoarthritis pain management market.

Cost and Pricing Strategy

VIVLODEX is available in 5 mg and 10 mg capsule strengths, which are 33% lower than other currently available oral meloxicam products. This lower dosage strategy is in line with FDA recommendations and could influence pricing and reimbursement dynamics. The cost-effectiveness of VIVLODEX, combined with its reduced need for rescue medication, may make it an attractive option for both patients and healthcare providers[1][4].

Regulatory Environment

The FDA approval of VIVLODEX was based on a comprehensive clinical development program, including a Phase 3 efficacy and safety study. The regulatory approval process highlighted the drug's safety profile and efficacy, which are crucial for its market acceptance. Compliance with FDA guidelines on NSAID usage further supports its market position[4].

Patient and Healthcare Provider Adoption

The adoption of VIVLODEX by patients and healthcare providers is influenced by its clinical efficacy, safety profile, and the reduced need for rescue medication. Studies have shown that patients taking VIVLODEX 10 mg once daily used significantly fewer doses of rescue pain medication compared to those on placebo. This data supports the drug's value proposition and is likely to drive adoption[1].

Competitive Landscape

The osteoarthritis pain management market is competitive, with various NSAIDs and other pain relief medications available. However, VIVLODEX's unique formulation and the clinical evidence supporting its efficacy set it apart. The drug's ability to reduce the need for rescue medication and its alignment with medical guidelines make it a competitive option in this market[1][4].

Future Outlook and Growth Potential

Given its clinical benefits and market positioning, VIVLODEX has significant growth potential. As more healthcare providers become aware of its advantages, the drug is likely to see increased prescription rates. Additionally, ongoing educational efforts and marketing strategies by Iroko Pharmaceuticals will further drive its adoption and revenue growth.

Challenges and Opportunities

While VIVLODEX offers several advantages, it also faces challenges such as competition from established brands and generic alternatives. However, its unique formulation and the growing awareness of the importance of using NSAIDs at the lowest effective dosage present opportunities for market expansion. Addressing potential medication errors and confusion with other meloxicam products, as highlighted by the FDA, will also be crucial for its long-term success[4].

Impact on Healthcare Costs

The reduced need for rescue medication associated with VIVLODEX can lead to lower overall healthcare costs. By managing osteoarthritis pain more effectively, the drug can reduce the economic burden associated with frequent use of rescue medications and potential hospitalizations due to inadequate pain management.

Patient Safety and Adverse Effects

Like all NSAIDs, VIVLODEX carries risks such as cardiovascular thrombotic events. However, its lower dosage and rapid absorption profile may mitigate some of these risks. Ensuring patient safety through proper dosing and monitoring will be essential for maintaining its positive market trajectory[1][4].

Conclusion on Market Dynamics

VIVLODEX has established itself as a valuable option in the osteoarthritis pain management market due to its clinical efficacy, unique formulation, and alignment with medical guidelines. Its ability to reduce the need for rescue medication and its potential to lower healthcare costs position it for continued growth and adoption.

Key Takeaways

• Clinical Efficacy: VIVLODEX has demonstrated significant reduction in osteoarthritis pain and rescue medication use.
• Market Position: It offers a unique low-dose NSAID option, differentiating it from other meloxicam products.
• Financial Potential: The drug has the potential to contribute significantly to the revenue of its manufacturer.
• Regulatory Compliance: Approved by the FDA based on comprehensive clinical studies.
• Patient and Provider Adoption: Supported by clinical data and alignment with medical guidelines.
• Competitive Landscape: Competes in a crowded market but stands out due to its unique formulation and clinical benefits.
• Future Outlook: Significant growth potential driven by increasing awareness and adoption.

FAQs

Q: What is VIVLODEX, and how does it differ from other meloxicam products?

A: VIVLODEX is a low-dose SoluMatrix® NSAID containing meloxicam in a reformulated version with reduced particle size, facilitating faster dissolution and rapid absorption. It is available in 5 mg and 10 mg capsule strengths, which are 33% lower than other currently available oral meloxicam products[1][4].

Q: What are the clinical benefits of VIVLODEX?

A: VIVLODEX has been shown to reduce osteoarthritis pain effectively and significantly decrease the need for rescue medication. Patients taking VIVLODEX 10 mg once daily used about half as many rescue pain medication doses as those receiving a placebo[1].

Q: How does VIVLODEX impact healthcare costs?

A: By managing osteoarthritis pain more effectively and reducing the need for rescue medication, VIVLODEX can lower overall healthcare costs associated with frequent use of rescue medications and potential hospitalizations due to inadequate pain management.

Q: What are the potential risks associated with VIVLODEX?

A: Like all NSAIDs, VIVLODEX carries risks such as cardiovascular thrombotic events. However, its lower dosage and rapid absorption profile may mitigate some of these risks[1][4].

Q: How is VIVLODEX positioned in the market?

A: VIVLODEX is positioned as a unique low-dose NSAID option that aligns with medical guidelines recommending the use of NSAIDs at the lowest effective dosage for the shortest duration. This differentiation sets it apart in the competitive osteoarthritis pain management market[1][4].

Cited Sources:

1. New Data Shows that VIVLODEX® Reduces Rescue Medication Use in Patients with Osteoarthritis Pain - Biopharma Dive
2. Vivoryon Therapeutics N.V. Reports Full Year 2023 Financial Results and Provides Varoglutamstat and Strategic Updates - Vivoryon Therapeutics
3. Annual Report 2019 - Vifor Pharma Group
4. 207233Orig1s000 - accessdata.fda.gov - FDA
5. Vivos Therapeutics Reports Third Quarter 2024 Financial Results and Provides Operational Update - Biospace