ANJESO Drug Patent Profile

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

Anjeso is a drug marketed by Baudax and is included in one NDA. There are seven patents protecting this drug.

This drug has forty-seven patent family members in thirteen countries.

The generic ingredient in ANJESO 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 Anjeso

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

Summary for ANJESO

International Patents:	47
US Patents:	7
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	145
Patent Applications:	3,959
Drug Prices:	Drug price information for ANJESO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ANJESO
What excipients (inactive ingredients) are in ANJESO?	ANJESO excipients list
DailyMed Link:	ANJESO at DailyMed

See drug prices for ANJESO

US Patents and Regulatory Information for ANJESO

ANJESO is protected by seven US patents.

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	10,463,673		Y
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020		DISCN	Yes	No	9,974,746		Y
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020		DISCN	Yes	No	11,458,145
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020		DISCN	Yes	No	10,471,067		Y
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020		DISCN	Yes	No	10,709,713

Expired US Patents for ANJESO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020	10,463,673
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020	8,512,727
Baudax	ANJESO	meloxicam	SOLUTION;INTRAVENOUS	210583-001	Feb 20, 2020	10,471,067

EU/EMA Drug Approvals for ANJESO

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

International Patents for ANJESO

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

Country	Patent Number	Title	Estimated Expiration
Spain	2326085
Japan	6072539
Japan	2020125345	ナノ粒子活性物質組成物におけるフレーク状凝集の軽減 (REDUCTION OF FLAKE-LIKE AGGREGATION IN NANOPARTICULATE ACTIVE AGENT COMPOSITIONS)
Germany	602004021107
Japan	4891774

ANJESO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ANJESO

Introduction

ANJESO, a transformative treatment for acute pain, has been making significant waves in the pharmaceutical market. Developed by Baudax Bio, this drug is a faster-acting injectable formulation of meloxicam, a COX-2 inhibitor. Here, we delve into the market dynamics and financial trajectory of ANJESO to understand its impact and future prospects.

Market Need for Non-Opioid Pain Therapeutics

The need for non-opioid pain therapeutics is paramount, especially given the opioid crisis. Over a 20-year period ending in 2019, at least 500,000 people died from opioid overdoses, highlighting the critical need for alternative pain management solutions[3].

Product Overview

ANJESO is a 24-hour, intravenous COX-2 non-steroidal anti-inflammatory (NSAID) designed to treat moderate-to-severe pain following surgery. Its faster-acting formulation reduces opioid use, making it a valuable option in the post-surgical care setting[3].

Market Approval and Adoption

Since its introduction, ANJESO has achieved significant milestones in terms of market approval and adoption. It has received approvals at more than 100 formularies across the United States in less than one year, indicating strong acceptance by healthcare providers[3].

Sales Performance

The sales performance of ANJESO has shown promising trends. In the third quarter of 2022, there was a modest increase of 16% in vials sold to end users compared to the same period in 2021. However, net product revenue for the three months ended September 30, 2022, was $0.2 million, which was a decrease from $0.3 million in the same period in 2021. This decrease was attributed to the reduction in field staff and additional sales to 340B hospitals with associated discounts[5].

For the nine months ended September 30, 2022, net product revenue related to ANJESO sales in the U.S. was $1.0 million, an increase from $0.7 million in the same period in 2021. This increase was driven by higher demand at existing accounts[5].

Financial Results

Revenue

The revenue from ANJESO, while growing, is still in its early stages. The net product revenue for the nine months ended September 30, 2022, was $1.0 million, indicating a gradual increase in sales[5].

Operating Expenses

Operating expenses for Baudax Bio, the company behind ANJESO, have been significant. For the nine months ended September 30, 2022, selling, general, and administrative expenses were $22.0 million, down from $33.8 million in the same period in 2021. The reduction was primarily due to decreases in personnel costs, marketing expenses, and other operational costs[5].

Cost of Sales and Research & Development

The cost of sales (excluding amortization of intangible assets) and research & development expenses have also been notable. For the nine months ended September 30, 2022, these costs were $2.217 million and $2.850 million, respectively[5].

Market Forecast

The market forecast for ANJESO is promising, given its unique positioning as a non-opioid pain therapeutic. The drug is expected to continue gaining traction as more healthcare providers seek alternatives to opioids. According to market forecasts, ANJESO is anticipated to play a significant role in the acute pain treatment market in the United States from 2023 to 2032[4].

Competitive Landscape

The competitive landscape for pain therapeutics is complex, with various opioid and non-opioid options available. However, ANJESO's unique formulation and its ability to reduce opioid use post-surgery position it favorably in the market. The drug's approval by over 100 formularies is a testament to its competitive edge[3].

Regulatory and Intellectual Property Insights

ANJESO has a strong intellectual property foundation, which is crucial for its market success. The drug's regulatory approvals and ongoing compliance with healthcare standards ensure its continued presence in the market[1].

SWOT Analysis

Strengths

• Unique formulation as a faster-acting injectable COX-2 inhibitor.
• Strong market acceptance with over 100 formulary approvals.
• Reduces opioid use, addressing a critical public health issue.

Weaknesses

• Initial revenue figures are modest compared to other pharmaceutical products.
• High operating expenses, particularly in selling, general, and administrative areas.

Opportunities

• Growing demand for non-opioid pain therapeutics.
• Potential for expansion into other pain management areas beyond post-surgical care.

Threats

• Competitive landscape with existing pain therapeutics.
• Regulatory changes that could impact market dynamics.

Industry Expert Insights

Gerri Henwood, President and CEO of Baudax Bio, noted, "We continue to receive positive feedback from physicians, and we continue to see increases in new accounts, units sold, reorder rates, and usage patterns across the surgical setting."[3]

Financial Guidance and Projections

While Baudax Bio's financial guidance specifically for ANJESO is not detailed in isolation, the company's overall financial performance and projections indicate a positive trajectory. The reduction in operating expenses and the increase in demand for ANJESO suggest a promising future for the drug[5].

Key Takeaways

• ANJESO is a significant player in the non-opioid pain therapeutic market.
• It has received strong market acceptance with over 100 formulary approvals.
• The drug's unique formulation reduces opioid use, addressing a critical public health issue.
• Financial performance is improving, though operating expenses remain a focus area.
• Market forecasts indicate continued growth and relevance in the acute pain treatment market.

FAQs

What is ANJESO, and how does it work?

ANJESO is a faster-acting injectable formulation of meloxicam, a COX-2 inhibitor, designed to treat moderate-to-severe pain following surgery. It works by reducing inflammation and pain without the use of opioids.

How has ANJESO been received in the market?

ANJESO has been well-received, with over 100 formulary approvals in the United States in less than one year. It has seen increases in new accounts, units sold, and usage patterns across surgical settings.

What are the financial highlights for ANJESO?

For the nine months ended September 30, 2022, net product revenue for ANJESO was $1.0 million, an increase from $0.7 million in the same period in 2021. Operating expenses have been reduced, but remain a significant factor.

What are the market forecasts for ANJESO?

ANJESO is expected to continue growing in the acute pain treatment market in the United States from 2023 to 2032, driven by its unique formulation and the increasing demand for non-opioid pain therapeutics.

How does ANJESO address the opioid crisis?

ANJESO reduces opioid use by providing an effective non-opioid alternative for post-surgical pain management, thereby addressing a critical aspect of the opioid crisis.

Sources

1. GlobeNewswire: ANJESO Drug Insight and Market Forecast in the United States 2023-2032[1].
2. PR Newswire: AMGEN REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS[2].
3. Managed Healthcare Executive: Non-opioid Pain Therapeutic Achieves More Than 100 Formulary Approvals[3].
4. Business Wire: United States ANJESO (meloxicam) Drug Insight and Market Forecasts 2019-2022 and 2023-2032[4].
5. GlobeNewswire: Baudax Bio Reports Third Quarter 2022 Financial Results and Business Highlights[5].