MYHIBBIN Drug Patent Profile

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

Myhibbin is a drug marketed by Azurity and is included in one NDA. There are three patents protecting this drug.

This drug has four patent family members in three countries.

The generic ingredient in MYHIBBIN is mycophenolate mofetil. There are thirty-eight drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Myhibbin

A generic version of MYHIBBIN was approved as mycophenolate mofetil by HIKMA on July 29^th, 2008.

Summary for MYHIBBIN

International Patents:	4
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	4,341
What excipients (inactive ingredients) are in MYHIBBIN?	MYHIBBIN excipients list
DailyMed Link:	MYHIBBIN at DailyMed

Pharmacology for MYHIBBIN

Drug Class

Antimetabolite Immunosuppressant

US Patents and Regulatory Information for MYHIBBIN

MYHIBBIN is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	MYHIBBIN	mycophenolate mofetil	SUSPENSION;ORAL	216482-001	May 1, 2024		RX	Yes	Yes			Y
Azurity	MYHIBBIN	mycophenolate mofetil	SUSPENSION;ORAL	216482-001	May 1, 2024		RX	Yes	Yes			Y
Azurity	MYHIBBIN	mycophenolate mofetil	SUSPENSION;ORAL	216482-001	May 1, 2024		RX	Yes	Yes			Y

International Patents for MYHIBBIN

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2020039263
European Patent Office	3836898	SUSPENSION PHARMACEUTIQUE POUR FORME GALÉNIQUE ORALE (PHARMACEUTICAL SUSPENSION FOR ORAL DOSAGE)
United Kingdom	2591396	Pharmaceutical suspension for oral dosage

Supplementary Protection Certificates for MYHIBBIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0281713	SPC/GB96/026	United Kingdom		PRODUCT NAME: MYCOPHENOLATE MOFETIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 53337 19951103; CH 53338 19951103; UK EU/1/96/005/001 19960214; UK EU/96/005/002 19960214
0281713	96C0031	Belgium		PRODUCT NAME: MYCOPHENOLATE MOFETIL; NAT. REGISTRATION NO/DATE: EU/1/96/005/001 19960214; FIRST REGISTRATION: CH 53337 19951103

MYHIBBIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Myhibbin

Introduction

Myhibbin, the newly FDA-approved ready-to-use mycophenolate mofetil oral suspension, is set to revolutionize the treatment of organ transplant recipients. Here, we delve into the market dynamics and financial trajectory of this innovative drug.

Market Need and Demand

Mycophenolate mofetil is an essential immunosuppressant for preventing organ rejection in transplant patients. With over 46,000 transplants performed in the US in 2023, the demand for effective and convenient immunosuppressive medications is significant. Myhibbin, being the first FDA-approved liquid formulation of mycophenolate, addresses a critical need for both pediatric and adult patients undergoing kidney, heart, or liver transplants[1][4].

Competitive Landscape

The approval of Myhibbin introduces a new player into the immunosuppressant market, which has traditionally been dominated by solid dosage forms. This ready-to-use oral suspension offers a unique advantage, particularly for pediatric patients and those with difficulty swallowing tablets or capsules. The lack of a liquid formulation in the market until now creates a significant opportunity for Azurity Pharmaceuticals to capture a substantial market share[1][4].

Pricing and Cost Considerations

Generic drug prices typically decline as more competitors enter the market. However, since Myhibbin is a new and innovative formulation, it is likely to command a premium price initially. As more generic versions of mycophenolate mofetil enter the market, prices may decrease, but the convenience and ease of use of Myhibbin could maintain its market value. Studies have shown that generic drug prices approach long-run marginal costs when there are eight or more competitors, but Myhibbin's unique formulation may mitigate this effect to some extent[3].

Regulatory Approval and Impact

The FDA approval of Myhibbin is a significant milestone for Azurity Pharmaceuticals. This approval not only validates the safety and efficacy of the drug but also opens up new market opportunities. The regulatory green light is expected to boost the company's revenue and enhance its reputation in the pharmaceutical industry. The approval process itself is a testament to the rigorous standards and safety protocols that Myhibbin has met, further reassuring patients and healthcare providers[1][4].

Financial Trajectory

Azurity Pharmaceuticals is poised for significant financial growth with the commercial launch of Myhibbin. Here are some key financial aspects to consider:

Revenue Potential

Given the high demand for immunosuppressants and the unique selling proposition of Myhibbin, the drug is expected to generate substantial revenue. Azurity Pharmaceuticals' focus on serving overlooked patients and providing innovative dose forms positions them well to capture a significant market share[1].

Market Expansion

The company plans to make Myhibbin commercially available in pharmacies nationwide in Q2 2024. This widespread availability will help in quickly penetrating the market and reaching a large number of patients. Additionally, the company's strategic partnerships and marketing efforts will further enhance the drug's reach[1].

Operational Efficiency

Azurity Pharmaceuticals has a strong track record of developing innovative medicines and ensuring high-quality manufacturing. The company's commitment to operational efficiency and patient-centric solutions will be crucial in maintaining the financial health and growth trajectory of Myhibbin[1].

Industry Trends and Growth Strategies

The pharmaceutical industry is witnessing significant growth driven by innovations in drug formulations and delivery systems. Here are some trends and strategies relevant to Myhibbin:

Innovation in Drug Formulations

Companies like Azurity Pharmaceuticals and Shilpa Medicare Limited are focusing on developing innovative dose forms and formulations to address unmet medical needs. This trend is expected to continue, with a focus on patient-centric solutions and advanced research and development[1][2].

Expansion into Emerging Markets

Shilpa Medicare Limited's strategy of expanding into emerging markets through marketing partners is a model that Azurity Pharmaceuticals could also adopt. This approach can help in increasing the global reach of Myhibbin and tapping into new revenue streams[2].

CDMO and API Business

The contract development and manufacturing organization (CDMO) and active pharmaceutical ingredient (API) segments are experiencing consistent growth. Azurity Pharmaceuticals could leverage these trends to enhance its manufacturing capabilities and ensure a steady supply of high-quality ingredients for Myhibbin[2].

Quotes from Industry Experts

Richard Blackburn, CEO of Azurity Pharmaceuticals: "We are very pleased that adult and pediatric organ transplant recipients will soon have access to the only FDA-approved ready-to-use oral liquid formulation of mycophenolate. Patients are our priority, and our purpose is to bring them new formulations that help them benefit from established medicines. Myhibbin's ready-to-use formulation provides patients, pharmacists, and caregivers an alternative to other mycophenolate dosage forms."[1][4]

Illustrative Statistics

• Over 46,000 transplants were performed in the US in 2023, indicating a high demand for immunosuppressive medications[1].
• Generic drug prices can fall by 35% to 50% above long-run marginal costs when there are fewer competitors, but Myhibbin's unique formulation may mitigate this effect[3].

Key Takeaways

• Market Need: Myhibbin addresses a significant need for a convenient and effective immunosuppressant in the form of an oral suspension.
• Competitive Advantage: The first FDA-approved liquid formulation of mycophenolate gives Myhibbin a unique market position.
• Financial Growth: Expected to generate substantial revenue with its commercial launch and widespread availability.
• Industry Trends: Focus on innovative drug formulations, expansion into emerging markets, and leveraging CDMO and API segments.

FAQs

Q: What is Myhibbin, and what is its primary use? A: Myhibbin is the first FDA-approved ready-to-use mycophenolate mofetil oral suspension, used to prevent organ rejection in adult and pediatric recipients of allogeneic kidney, heart, or liver transplants.

Q: Who is the target market for Myhibbin? A: The target market includes adult and pediatric organ transplant recipients, particularly those who have difficulty swallowing tablets or capsules.

Q: How does Myhibbin differ from other mycophenolate mofetil formulations? A: Myhibbin is the only FDA-approved liquid formulation of mycophenolate mofetil, offering a convenient and ready-to-use alternative to traditional solid dosage forms.

Q: What are the financial expectations for Myhibbin? A: Myhibbin is expected to generate significant revenue due to its unique formulation and high demand in the immunosuppressant market.

Q: When will Myhibbin be commercially available? A: Myhibbin is expected to become commercially available in pharmacies nationwide in Q2 2024.

Sources

1. AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF MYHIBBIN™, THE ONLY READY-TO-USE MYCOPHENOLATE MOFETIL ORAL SUSPENSION. PR Newswire.
2. Shilpa Medicare Limited - AWS. Shilpa Medicare Limited Annual Report 2023-24.
3. Generic Drug Industry Dynamics. Federal Trade Commission.
4. FDA Approves Azurity Pharmaceuticals' Myhibbin as an Oral Suspension for Organ Transplant Recipients. PharmExec.