Mycophenolate sodium - Generic Drug Details

What are the generic sources for mycophenolate sodium and what is the scope of patent protection?

Mycophenolate sodium is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Concord Biotech Ltd, Fosun Wanbang, Rk Pharma, Teva Pharms Usa, Twi Pharms, Yichang Humanwell, and Novartis, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for mycophenolate sodium. Eighteen suppliers are listed for this compound.

Summary for mycophenolate sodium

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	13
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	18
Clinical Trials:	138
Patent Applications:	335
DailyMed Link:	mycophenolate sodium at DailyMed

Recent Clinical Trials for mycophenolate sodium

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

Sponsor	Phase
India Alliance	PHASE4
Christian Medical College, Vellore, India	PHASE4
Medical Research Council	PHASE4

See all mycophenolate sodium clinical trials

Pharmacology for mycophenolate sodium

Drug Class

Antimetabolite Immunosuppressant

Paragraph IV (Patent) Challenges for MYCOPHENOLATE SODIUM

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

US Patents and Regulatory Information for mycophenolate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biocon Pharma	MYCOPHENOLATE SODIUM	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	214630-001	Nov 29, 2021	AB	RX	No	No
Novartis	MYFORTIC	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	AB	RX	Yes	Yes
Teva Pharms Usa	MYCOPHENOLATE SODIUM	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	202720-002	Oct 30, 2014		DISCN	No	No
Apotex Inc	MYCOPHENOLATE SODIUM	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	091558-002	Aug 19, 2014	AB	RX	No	No
Aurobindo Pharma Ltd	MYCOPHENOLATE SODIUM	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	218603-002	Feb 27, 2024	AB	RX	No	No

Expired US Patents for mycophenolate sodium

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

Market Dynamics and Financial Trajectory for Mycophenolate Sodium

Last updated: February 24, 2026

What is Mycophenolate Sodium?

Mycophenolate sodium is an immunosuppressant drug primarily used to prevent organ rejection in transplant patients. It is a prodrug of mycophenolate mofetil, with specific formulation differences that influence bioavailability. The drug inhibits inosine monophosphate dehydrogenase, disrupting lymphocyte proliferation.

Market Size and Growth Trends

Global Market Valuation

• Estimated market size in 2022: approximately USD 1.2 billion.
• Projected compound annual growth rate (CAGR) (2023–2028): around 8-10%.

Key Drivers

1. Increasing organ transplantation procedures

   • Kidney, liver, and heart transplants drive demand.
   • US transplants (2021): 23,869 kidney; 8,865 liver; 2,679 heart cases.

2. Evolving immunosuppressant protocols

   • Shift toward targeted therapies with fewer side effects may influence formulations.

3. Growing healthcare infrastructure in emerging markets

   • Asia-Pacific market expansion (CAGR: 9% from 2023–2028).

Market Segmentation

Segment	Share (2022)	Growth Drivers
Solid Organ Transplant	70%	High transplantation rates
Autoimmune Disorders	15%	Off-label use, evolving treatment protocols
Other	15%	Rare diseases, experimental uses

Competitive Landscape

Leading Players

• Fresenius Kabi
• HOSPIRA (Pfizer)
• Teva Pharmaceutical Industries
• Sandoz (Novartis)

Market Strategies

• Expansion into emerging markets.
• Development of biosimilars or branded formulations with improved dosing profiles.
• Collaborations with transplant centers for clinical adoption.

Regulatory and Policy Factors

Approval Status

• Approved in the US (FDA), EU (EMA), and other regions.
• Variability in approval for specific indications; off-label use margin present.

Pricing and Reimbursement

• Price range: USD 750–USD 1,000 per month (brand).
• Reimbursement policies influence patient access; some markets face price pressures and generic competition.

Patent Landscape

• Pfizer’s CellCept (mycophenolate mofetil) holds exclusivity until 2025 in the US.
• Patent challenges and biosimilar development affect market dynamics post-expiry.

Financial Trajectory

Revenue Projections

• 2022: Estimated USD 1.2 billion globally.
• 2023: Approximate USD 1.3 billion, with steady growth expected.
• 2028 target: USD 2 billion, assuming consistent growth and market penetration.

Factors Influencing Revenue

• Expansion in transplantation procedures.
• Entry of biosimilars reducing prices and expanding access.
• Increasing autoimmune disorder treatments, though less prominently than transplant indications.

Risks

• Patent expirations leading to generic competition.
• Regulatory delays, especially for new formulations or indications.
• Stringent pricing controls in certain territories.

Key Takeaways

• The mycophenolate sodium market is expanding due to higher transplantation rates and healthcare modernization in emerging markets.
• Leading players focus on geographic expansion, biosimilars, and clinical collaborations.
• Revenue growth remains stable but faces competitive pressures from generics post-2025 patent expiry.
• Pricing dynamics and reimbursement policies significantly influence profit margins.
• Regulatory landscapes and approval statuses vary globally, affecting market accessibility.

FAQs

Q1: How does mycophenolate sodium differ from mycophenolate mofetil?
A1:* Mycophenolate sodium is a formulation designed for direct absorption, typically causing fewer gastrointestinal side effects than mycophenolate mofetil, which requires conversion in the body.

Q2: What are the main indications for mycophenolate sodium?
A2:* The primary indication is to prevent organ rejection after transplantation. Off-label uses include autoimmune diseases such as lupus nephritis.

Q3: How does patent expiry affect the market for mycophenolate sodium?
A3:* Patent expiration allows generic manufacturers to produce cheaper equivalents, increasing competition, reducing prices, and potentially decreasing revenue for branded formulations.

Q4: Which regions represent the fastest market growth?
A4:* Asia-Pacific offers the highest growth potential, driven by increasing transplant rates and expanding healthcare access.

Q5: What challenges threaten future market growth?
A5:* Challenges include generic competition post-patent, regulatory hurdles, pricing pressures, and potential safety concerns influencing prescribing patterns.

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References

[1] MarketsandMarkets. (2022). Global Immunosuppressants Market Forecast to 2028.
[2] Organ Procurement and Transplantation Network. (2021). Transplant Statistics.
[3] Pfizer. (2021). CellCept Product Label.
[4] European Medicines Agency. (2022). Regulatory Approvals and Variations.
[5] IQVIA. (2022). Pharmaceutical Market Data.