MYFORTIC Drug Patent Profile

Which patents cover Myfortic, and when can generic versions of Myfortic launch?

Myfortic is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in MYFORTIC is mycophenolic sodium. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the mycophenolic sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Myfortic

A generic version of MYFORTIC was approved as mycophenolic sodium by APOTEX INC on August 21^st, 2012.

Summary for MYFORTIC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	146
Clinical Trials:	118
Drug Prices:	Drug price information for MYFORTIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MYFORTIC
What excipients (inactive ingredients) are in MYFORTIC?	MYFORTIC excipients list
DailyMed Link:	MYFORTIC at DailyMed

See drug prices for MYFORTIC

Recent Clinical Trials for MYFORTIC

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Nantes University Hospital	Phase 4
Chiesi Farmaceutici S.p.A.	Phase 4
Regimmune Corporation	Phase 1

See all MYFORTIC clinical trials

Pharmacology for MYFORTIC

Drug Class

Antimetabolite Immunosuppressant

Paragraph IV (Patent) Challenges for MYFORTIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYFORTIC	Delayed-release Tablets	mycophenolic sodium	180 mg	050791	1	2009-06-03
MYFORTIC	Delayed-release Tablets	mycophenolic sodium	360 mg	050791	1	2009-02-02

US Patents and Regulatory Information for MYFORTIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-001	Feb 27, 2004	AB	RX	Yes	No
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	AB	RX	Yes	Yes

Expired US Patents for MYFORTIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	6,172,107
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-001	Feb 27, 2004	6,025,391
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	6,306,900
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	6,025,391
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-001	Feb 27, 2004	6,306,900
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-001	Feb 27, 2004	6,172,107

International Patents for MYFORTIC

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	2243	Enteric-coated pharmaceutical compositions of mycophenolate
Portugal	892640
Taiwan	457098
Colombia	4900024	COMPOSICIONES FARMACEUTICAS CON REVESTIMIENTO ETERICO
Austria	408415
Germany	69727559

Supplementary Protection Certificates for MYFORTIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0892640	SPC/GB04/030	United Kingdom		SPC/GB04/030: 20050609, EXPIRES: 20171023
0892640	SPC017/2004	Ireland		SPC017/2004, 20060201, EXPIRES: 20171023
0892640	91094	Luxembourg		91094, EXPIRES: 20181010
0892640	CA 2004 00024	Denmark
0892640	C00892640/01	Switzerland		PRODUCT NAME: ACIDUM MYCOPHENOLICUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56115 24.10.2002
0892640	300157	Netherlands		300157, 20170410, EXPIRES: 20181009

MYFORTIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Myfortic

Introduction to Myfortic

Myfortic, also known as mycophenolate mofetil, is an immunosuppressive medication widely used to prevent the rejection of transplanted organs such as kidneys, livers, and hearts. It is often prescribed in conjunction with other medications like cyclosporine and steroids. Here, we will delve into the market dynamics and financial trajectory of Myfortic.

Market Size and Growth

The global mycophenolate mofetil market, which includes Myfortic, has been experiencing significant growth. As of 2021, the market size was valued at USD 1487.9 million. It is projected to reach USD 2735.54 million by 2031, exhibiting a Compound Annual Growth Rate (CAGR) of 6.28% during this period[1].

Driving Factors

Several factors are driving the growth of the Myfortic market:

Increasing Demand in Healthcare

The growing need for immunosuppressive medications in the pharmaceutical and healthcare sectors is a major driver. Myfortic is used not only for organ transplantation but also for treating various autoimmune diseases such as systemic lupus erythematosus (SLE), inflammatory myopathies, and systemic sclerosis (SSc)[4].

Rising Healthcare Expenditure

Increasing healthcare expenditure globally is another significant factor. As healthcare infrastructure improves and more people have access to advanced medical treatments, the demand for Myfortic and similar medications is expected to rise[4].

Growing Geriatric Population

The increasing geriatric population is also a key driver. Older individuals are more likely to undergo organ transplants and suffer from autoimmune diseases, thereby increasing the demand for Myfortic[4].

Clinical Trials and Research

The rise in clinical trial studies and research activities focused on mycophenolate mofetil is further boosting the market. For instance, studies have shown potential benefits of Myfortic in reducing HIV reservoirs, which could open up new therapeutic avenues[3].

Market Challenges

Despite the positive growth trajectory, the Myfortic market faces several challenges:

High Cost

One of the major impediments is the high cost associated with the product. This can limit accessibility, especially in regions with lower disposable incomes[4].

Side Effects

Myfortic is associated with several side effects, including diarrhea, pain, vomiting, blood infections, sore throat, high blood pressure, and swelling. These side effects can hamper market growth as patients and healthcare providers seek alternative treatments with fewer adverse effects[4].

Lack of Awareness

Limited awareness about the benefits and uses of Myfortic in certain regions can also challenge market growth. Educational campaigns and increased public knowledge are crucial to overcoming this barrier[1].

Key Players

The Myfortic market is dominated by several key players:

• Par Pharmaceutical
• West Ward Pharmaceuticals
• Mylan
• Jubilant Cadista
• Teva
• Alkem Laboratories
• Strides Pharma
• Genentech
• Accord Healthcare
• Sandoz
• Akorn
• Passauer Pharma GmbH[1].

These companies play a significant role in manufacturing, distributing, and marketing Myfortic, influencing the market dynamics through their strategies and innovations.

Regulatory and Ethical Considerations

The pharmaceutical industry, including the Myfortic market, is heavily regulated. Companies must comply with strict laws and ethical standards to avoid legal repercussions. For example, Novartis faced a significant settlement of $390 million due to allegations of kickbacks to pharmacies to encourage the sale of Myfortic and other drugs, highlighting the importance of ethical marketing practices[2].

Geographic Market Analysis

The Myfortic market is geographically diverse, with different regions contributing to its growth:

North America

North America dominates the market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure[4].

Asia-Pacific

The Asia-Pacific region is expected to grow significantly during the forecast period due to increasing research and development activities and rising government support[4].

Patient Epidemiology and Treatment Plans

The demand for Myfortic is also influenced by patient epidemiology. For instance, the treatment plan for patients with autoimmune diseases or those undergoing organ transplants often includes Myfortic. Patient reports and treatment plans, such as switching from Cellcept to Myfortic due to side effects, further illustrate the importance of this medication in clinical practice[5].

Financial Trajectory

The financial trajectory of Myfortic is positive, driven by the growing market size and increasing demand. Here are some key financial insights:

• Market Size: Expected to reach USD 2735.54 million by 2031[1].
• CAGR: 6.28% from 2021 to 2031[1].
• Revenue Drivers: Increasing healthcare expenditure, growing geriatric population, and rising demand for immunosuppressive medications[4].

Conclusion

The market dynamics and financial trajectory for Myfortic are robust, driven by increasing demand in the healthcare sector, rising healthcare expenditure, and growing clinical research. However, the market faces challenges such as high costs and side effects, which need to be addressed through innovative strategies and educational campaigns.

Key Takeaways

• The global mycophenolate mofetil market, including Myfortic, is expected to reach USD 2735.54 million by 2031.
• The market is driven by increasing healthcare expenditure, growing geriatric population, and rising demand for immunosuppressive medications.
• Key players such as Par Pharmaceutical, West Ward Pharmaceuticals, and Mylan dominate the market.
• Regulatory compliance and ethical marketing practices are crucial.
• Geographic regions like North America and Asia-Pacific are significant contributors to the market growth.

FAQs

Q: What is the projected market size of mycophenolate mofetil by 2031? A: The global mycophenolate mofetil market is projected to reach USD 2735.54 million by 2031[1].

Q: What is the CAGR of the mycophenolate mofetil market from 2021 to 2031? A: The market is expected to exhibit a CAGR of 6.28% from 2021 to 2031[1].

Q: What are the primary drivers of the mycophenolate mofetil market? A: The primary drivers include increasing healthcare expenditure, growing geriatric population, and rising demand for immunosuppressive medications[4].

Q: Which regions dominate the mycophenolate mofetil market? A: North America and Asia-Pacific are the dominant regions due to their well-developed healthcare infrastructure and increasing research activities[4].

Q: What are some of the challenges facing the mycophenolate mofetil market? A: High costs, side effects, and lack of awareness are some of the significant challenges facing the market[4].

Sources

1. Business Research Insights: Mycophenolate Mofetil Market Size, Share | 2024 To 2031
2. Pharmacy Times: Pharmacy Kickbacks Lawsuit Spurs Novartis Settlement
3. Oxford Academic: Stable HIV Reservoir Despite Prolonged Low-Dose Mycophenolate
4. Data Bridge Market Research: Global Mycophenolate Market - Industry Trends and Forecast to 2029
5. New York State Department of Financial Services: Case Number: 202302-158908