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 five 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:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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 five 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	12,194,143		Y
Azurity	MYHIBBIN	mycophenolate mofetil	SUSPENSION;ORAL	216482-001	May 1, 2024		RX	Yes	Yes	11,931,455		Y
Azurity	MYHIBBIN	mycophenolate mofetil	SUSPENSION;ORAL	216482-001	May 1, 2024		RX	Yes	Yes	12,097,285		Y
Azurity	MYHIBBIN	mycophenolate mofetil	SUSPENSION;ORAL	216482-001	May 1, 2024		RX	Yes	Yes	12,226,526		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
United Kingdom	2591396	Pharmaceutical suspension for oral dosage
United Kingdom	202103764
European Patent Office	3836898	SUSPENSION PHARMACEUTIQUE POUR FORME GALÉNIQUE ORALE (PHARMACEUTICAL SUSPENSION FOR ORAL DOSAGE)

Supplementary Protection Certificates for MYHIBBIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0281713	96C0031	Belgium		PRODUCT NAME: MYCOPHENOLATE MOFETIL; NAT. REGISTRATION NO/DATE: EU/1/96/005/001 19960214; FIRST REGISTRATION: CH 53337 19951103
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

Market Dynamics and Financial Trajectory for MYHIBBIN

Last updated: February 16, 2026

Overview
MYHIBBIN (generic: rifampin), marketed by Serum Institute of India, addresses tuberculosis (TB) and bacterial infections. Its market position stems from its use in TB treatment regimens, notably in developing countries, alongside other antibiotics.

Market Size and Segmentation
The global TB drug market was valued at approximately $1.2 billion in 2022 and is projected to reach $1.9 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 6.2% [1]. Rifampin accounts for roughly 35% of the regimen sales, with the rest divided among other first-line drugs.

Drivers

• Global TB prevalence remains high at 10 million cases annually (WHO 2022).
• Increasing drug-resistant TB cases (multidrug-resistant TB) expand demand for combination therapies.
• Government initiatives in India, China, and Africa promote access to affordable TB medications.
• Rising awareness and diagnostic capabilities support earlier treatment interventions.

Challenges

• Competition from established generic manufacturers including Mylan, Sun Pharma, and Lupin.
• Price pressures due to large generic manufacturing capacity, especially in India.
• Regulatory policies worldwide influence drug availability and pricing; some countries enforce price controls, impacting margins.
• Limited innovation in rifampin formulations; most market activity centers on production volume and cost efficiency.

Market Structure and Competition The rifampin segment features several key players:	Company	Market share (est.)	Key Production Sites	Strategies
Serum Institute	15%	India	Focus on affordability, large-volume manufacturing
Mylan	12%	India, Europe	Expand generic portfolio, partnerships
Sun Pharma	10%	India	Cost leadership, export focus
Lupin	8%	India	Broad high-volume portfolio

Regulatory and Patent Landscape

• Rifampin patents expired globally around 2002, allowing widespread generic production.
• Regulatory filings are streamlined in India, China, and emerging markets, facilitating rapid market entry.
• Some countries enforce strict quality standards, prompting tiered pricing and quality assurance programs.

Financial Trajectory
Current revenues for rifampin products are estimated between $300 million and $400 million globally, with Indian generics capturing a significant portion. Serum Institute’s revenues from MYHIBBIN are not publicly detailed but are part of their broader antibiotic portfolio.

Projection indicates compounded annual growth of 4-6% over the next five years, driven by increased TB testing, treatment programs, and demand for affordable antibiotics. However, margins may compress as intensified competition and price controls take hold.

Strategic Outlook

• Focus on expanding access through partnerships with public health initiatives.
• Investment in quality assurance to meet international standards.
• Diversification into combination formulations to capture more hospital and outpatient markets.
• Efforts to differentiate via supply chain efficiency, not R&D breakthroughs.

Regulatory Trends and Policy Impact
Global health policies prioritize TB control; organizations like WHO and the Global Fund support drug access, influencing market volume. Price negotiations and procurement policies in countries like India and South Africa might limit profit margins but enhance volume sales.

Key Takeaways

• MYHIBBIN operates in a high-volume, mature market with steady growth prospects primarily driven by global TB prevalence.
• Competition is intense, with cost efficiency and global access remaining core to market positioning.
• Price pressures and regulatory frameworks remain critical considerations for financial performance.
• Opportunities exist in expanding into combination therapies and emerging markets, although innovation relevance is minimal.
• The overall market trajectory remains positive, supported by global health priorities.

FAQs

1. How does MYHIBBIN compare to other rifampin formulations in the global market?
   It competes primarily on price and supply chain efficiency; no significant differentiation exists besides affordability.

2. What are the primary growth regions for MYHIBBIN?
   India, Africa, Southeast Asia, and China dominate growth due to high TB burden and government support.

3. How might new TB treatment protocols affect MYHIBBIN’s market?
   Shift toward combination therapies and newer drugs could marginally impact volume, but rifampin remains a cornerstone.

4. Are there upcoming regulatory changes that could influence MYHIBBIN’s sales?
   Stricter quality standards in certain markets and pricing policies in emerging markets could impact profit margins.

5. What is the outlook on future innovation for rifampin?
   Innovation appears limited; efforts focus on manufacturing process improvements and combination formulations.

Sources
[1] Market Research Future, "Global Tuberculosis Drugs Market," 2023.