You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

MYCOPHENOLIC SODIUM Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Mycophenolic Sodium is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amta, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Concord Biotech Ltd, Rk Pharma, Teva Pharms Usa, Twi Pharms, and Wanbang Biopharms. and is included in twelve NDAs.

The generic ingredient in MYCOPHENOLIC SODIUM 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 Mycophenolic Sodium

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

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for MYCOPHENOLIC SODIUM?
  • What are the global sales for MYCOPHENOLIC SODIUM?
  • What is Average Wholesale Price for MYCOPHENOLIC SODIUM?
Summary for MYCOPHENOLIC SODIUM
Drug patent expirations by year for MYCOPHENOLIC SODIUM
Recent Clinical Trials for MYCOPHENOLIC SODIUM

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

SponsorPhase
AstraZenecaPhase 3
University Hospital, ToursPhase 4
Lee's Pharmaceutical LimitedPhase 4

See all MYCOPHENOLIC SODIUM clinical trials

Pharmacology for MYCOPHENOLIC SODIUM
Paragraph IV (Patent) Challenges for MYCOPHENOLIC SODIUM
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 MYCOPHENOLIC SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare MYCOPHENOLIC SODIUM mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 202555-001 Aug 23, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rk Pharma MYCOPHENOLIC SODIUM mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 091248-001 Jan 8, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wanbang Biopharms MYCOPHENOLIC SODIUM mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 216637-002 May 29, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

MYCOPHENOLIC SODIUM Market Analysis and Financial Projection Experimental

Mycophenolic Acid and Mycophenolic Sodium: Market Dynamics and Financial Trajectory

Introduction

Mycophenolic acid, and its derivatives such as mycophenolic sodium, are crucial immunosuppressant drugs used primarily to prevent organ rejection in transplant patients and to treat various autoimmune diseases. Here, we delve into the market dynamics and financial trajectory of mycophenolic sodium, a key formulation of mycophenolic acid.

Market Size and Growth

The global mycophenolic acid market, which includes mycophenolic sodium, was valued at USD 100 million in 2023 and is projected to reach USD 147.7 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[4].

Segmentation of the Market

The market is segmented based on application, product type, and geographical regions. The key applications include immunosuppressive therapy, organ transplantation, treatment of autoimmune diseases, and dermatology. The primary products are mycophenolate mofetil and mycophenolate sodium[4].

Geographical Performance

  • North America: This region is expected to register the highest revenue CAGR over the forecast period due to the advanced pharmaceutical industry and significant investments in healthcare infrastructure[1].
  • Europe: Europe holds the second-largest market share, with room for growth driven by advancements in bionics and biomedical equipment[1].
  • Asia Pacific: The market in this region is expected to grow rapidly due to increasing urban prosperity, higher willingness to pay for organ transplants, and a rising incidence of renal diseases[1].

Product Forms and Usage

Mycophenolic acid is available in two main forms: mycophenolate mofetil and mycophenolate sodium. Mycophenolate sodium, marketed as Myfortic, is an enteric formulation that delivers mycophenolic acid (MPA) and is used in conjunction with other drugs to prevent organ rejection in patients with kidney, heart, or liver transplants[2].

Clinical Efficacy and Safety

Studies have shown that mycophenolate sodium (Myfortic) has similar efficacy to mycophenolate mofetil in preventing acute rejection and graft loss in renal transplant patients. The incidence of treatment failure, including biopsy-proven acute rejection, graft loss, death, and lost to follow-up, was comparable between Myfortic and mycophenolate mofetil-treated patients at 6 and 12 months[2][5].

Cost Trends and Patient Payments

The cost of mycophenolic acid products has seen a significant decline over recent years. From 2008 to 2013, average annualized out-of-pocket payments by patients for mycophenolic acid decreased substantially, with reductions of 71%, 77%, and 79% for kidney, liver, and heart transplant recipients, respectively. This trend is attributed to the availability of generic formulations and changes in healthcare policies[3].

Regulatory and Pharmaceutical Advances

The approval of new formulations and indications by regulatory bodies has been a key driver of market growth. Pharmaceutical companies are focusing on developing innovative formulations and enhancing drug delivery methods to improve therapeutic efficacy and patient compliance. This includes advancements in pharmacogenomics and biotechnology, which tailor medical approaches to maximize therapeutic outcomes[4].

Economic and Social Factors

The expansion of healthcare infrastructure, increasing investments in research projects, and favorable healthcare regulations supporting organ donation and transplant programs are significant factors driving the market. Additionally, the growing incidence of autoimmune diseases and the need for efficient immunosuppressive therapies are contributing to the market's steady expansion[1][4].

Key Players and Market Competition

The mycophenolic acid market is competitive, with key players including Roche Holding AG, Novartis AG, Mylan N.V., Lupin Limited, Teva Pharmaceutical Industries Ltd., and others. These companies are involved in the development of new formulations and the enhancement of existing products to maintain market share and drive growth[4].

Future Outlook

The market for mycophenolic acid, including mycophenolic sodium, is poised for continued growth driven by the increasing demand for immunosuppressive therapies, advancements in pharmaceutical technology, and favorable regulatory environments. As the field of immunology and transplant medicine continues to evolve, the demand for mycophenolic acid is expected to rise, contributing to the market's financial trajectory.

Key Takeaways

  • The global mycophenolic acid market is expected to grow from USD 100 million in 2023 to USD 147.7 million by 2031.
  • Mycophenolic sodium (Myfortic) is a key formulation used to prevent organ rejection in transplant patients.
  • The market is driven by the need for immunosuppressive therapies, advancements in pharmaceutical technology, and favorable regulatory environments.
  • North America and Europe are significant markets, with the Asia Pacific region showing rapid growth.
  • The cost of mycophenolic acid products has decreased significantly due to the availability of generic formulations.

FAQs

What is mycophenolic acid used for?

Mycophenolic acid is used as an immunosuppressant to prevent organ rejection in patients with kidney, heart, or liver transplants and to treat autoimmune diseases such as Crohn's disease and lupus[1].

What are the main forms of mycophenolic acid?

The main forms are mycophenolate mofetil and mycophenolate sodium, with mycophenolate sodium being marketed as Myfortic[2].

How has the cost of mycophenolic acid products changed over time?

The cost has decreased significantly from 2008 to 2013, with out-of-pocket payments by patients reducing by 71%, 77%, and 79% for kidney, liver, and heart transplant recipients, respectively[3].

Which regions are expected to drive the growth of the mycophenolic acid market?

North America, Europe, and the Asia Pacific region are expected to be key drivers of market growth due to their advanced healthcare infrastructure and increasing demand for immunosuppressive therapies[1][4].

What are the key factors driving the market growth for mycophenolic acid?

Key factors include the growing incidence of autoimmune diseases, advancements in pharmaceutical technology, favorable regulatory environments, and increasing investments in healthcare infrastructure[1][4].

Sources

  1. Reports and Data: Mycophenolic Acid Market Size, Share, Trends and Forecast by 2030.
  2. FDA: Myfortic® (mycophenolic acid) delayed-release tablets.
  3. Clinical Journal of the American Society of Nephrology: Secular Trends in the Cost of Immunosuppressants after Solid Organ Transplantation.
  4. Market Research Intellect: Mycophenolic Acid Market Size and Projections.
  5. FDA: Myfortic (mycophenolic acid).

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.