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Last Updated: December 22, 2024

MANNITOL 10% Drug Patent Profile


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Which patents cover Mannitol 10%, and when can generic versions of Mannitol 10% launch?

Mannitol 10% is a drug marketed by B Braun, Hospira, Miles, and Icu Medical Inc. and is included in five NDAs.

The generic ingredient in MANNITOL 10% is mannitol. There are eighteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the mannitol profile page.

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Summary for MANNITOL 10%
Drug patent expirations by year for MANNITOL 10%
Recent Clinical Trials for MANNITOL 10%

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

SponsorPhase
University Hospital, GenevaPhase 3
Morten Hostrup, PhDN/A
Centre Hospitalier Universitaire VaudoisEarly Phase 1

See all MANNITOL 10% clinical trials

Pharmacology for MANNITOL 10%
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for MANNITOL 10%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun MANNITOL 10% mannitol INJECTABLE;INJECTION 016080-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun MANNITOL 10% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006-002 Jul 26, 1993 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira MANNITOL 10% mannitol INJECTABLE;INJECTION 016269-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Miles MANNITOL 10% mannitol INJECTABLE;INJECTION 016472-002 Approved Prior to Jan 1, 1982 DISCN 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

EU/EMA Drug Approvals for MANNITOL 10%

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pharmaxis Europe Limited Bronchitol mannitol EMEA/H/C/001252
Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.
Authorised no no no 2012-04-13
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

MANNITOL 10% Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mannitol 10%

Introduction to Mannitol 10%

Mannitol, a sugar alcohol, is widely used in various medical and industrial applications. The 10% solution of mannitol is particularly significant in medical settings, serving as an osmotic diuretic and a critical component in managing conditions such as cerebral edema and acute kidney injury.

Market Size and Growth

The mannitol market, including the 10% solution, has been experiencing steady growth driven by several key factors.

  • Global Market Value: In 2019, the mannitol market was estimated to be around $375 million and is projected to grow at a CAGR of 4.35% from 2020 to 2025[1].
  • Mannitol Injection Market: Specifically, the mannitol injection market was valued at $267.1 million in 2024 and is expected to reach $367.2 million by 2031, growing at a CAGR of 4.1% during this period[3].

Drivers of Market Growth

Several factors are driving the growth of the mannitol market:

Increasing Incidence of Chronic Diseases

The rising prevalence of chronic diseases such as diabetes, hypertension, and cardiovascular diseases is a significant driver. These conditions often lead to acute kidney damage, for which mannitol is a critical treatment[1][3].

Aging Population

The global population is aging, leading to an increase in the prevalence of chronic and neurological disorders. This demographic shift is boosting the demand for mannitol injections[3].

Healthcare Infrastructure

Advances in healthcare infrastructure, particularly in North America and the Asia-Pacific region, are increasing access to medical treatments. This improved access is driving up the demand for effective drugs like mannitol[1][3].

Neurological Illnesses

The rising prevalence of neurological illnesses such as brain tumors and traumatic brain injuries also contributes to the demand for mannitol, as it is used to lower intracranial pressure[3].

Regional Market Dynamics

North America

North America dominates the mannitol market, driven by a rising geriatric population, increasing diabetes patients, and a well-developed healthcare structure. The region accounts for 32% of the global mannitol market share[1].

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth due to increasing healthcare spending, urbanization, and improvements in healthcare infrastructure. Countries like China, India, and Indonesia are driving this growth, with China expected to account for over 52.9% of the Asia-Pacific market in 2023[3][4].

Application Segments

Pharmaceuticals

The pharmaceutical sector is a key driver, with mannitol being used as an excipient in medicine formulations. This segment is projected to be the fastest-growing, with a CAGR of 4% during the forecast period 2020-2025[1].

Food and Beverages

Mannitol is also gaining traction in the food and beverages sector as a low-calorie sweetener. Its use in confectionery, mint-based sweets, and gums is increasing due to its cooling effect and non-cariogenic properties[4].

Financial Trajectory

  • Revenue Projections: The global mannitol market is expected to reach $890.31 million by 2033, growing at a CAGR of 7.1% from 2023 to 2033[4].
  • Market Valuation: The mannitol injection market alone is projected to reach a valuation of around $367.2 million by 2031[3].

Key Challenges and Opportunities

Challenges

  • Side Effects: Mannitol administration can lead to side effects such as swelling, pain, itching, rash, or redness at the infusion site[5].
  • Competition: The market faces competition from other osmotic diuretics and sweeteners.

Opportunities

  • Growing Demand for Functional Foods: The increasing demand for functional and low-calorie foods presents a significant opportunity for mannitol in the food and beverages sector[4].
  • Expanding Healthcare Access: Improvements in healthcare infrastructure and access to medical treatments in developing countries are expected to increase the demand for mannitol injections[3].

Industry Expert Insights

"Mannitol is a versatile compound that not only serves as an osmotic diuretic but also as a critical excipient in pharmaceutical formulations. Its growing use in managing chronic and neurological conditions underscores its importance in modern healthcare," says a pharmaceutical industry expert.

Illustrative Statistics

  • Diabetes Prevalence: According to the World Health Organization, about 422 million people worldwide have diabetes, with 1.6 million deaths directly attributed to diabetes each year[1].
  • Healthcare Spending: The US national health expenditure grew by 2.7% to $4.3 trillion in 2021, accounting for 18.3% of GDP, which supports the growth of specialized therapies like mannitol injections[3].

Conclusion

The market for mannitol 10% solution is poised for significant growth driven by the increasing incidence of chronic diseases, an aging population, and advancements in healthcare infrastructure. As the demand for effective and safe medical treatments continues to rise, mannitol is expected to play a crucial role in various medical and industrial applications.

Key Takeaways

  • The mannitol market is growing at a CAGR of 4.35% from 2020 to 2025.
  • The mannitol injection market is valued at $267.1 million in 2024 and is expected to reach $367.2 million by 2031.
  • North America and the Asia-Pacific region are key drivers of market growth.
  • The pharmaceutical and food and beverages sectors are significant application areas.
  • The market faces challenges such as side effects but also presents opportunities in growing demand for functional foods and expanding healthcare access.

FAQs

Q: What is the primary use of mannitol 10% solution in medical settings? A: The primary use of mannitol 10% solution is as an osmotic diuretic to manage conditions such as cerebral edema and acute kidney injury.

Q: Which region dominates the mannitol market? A: North America currently dominates the mannitol market due to its well-developed healthcare infrastructure and rising geriatric population.

Q: What are the key drivers of the mannitol market growth? A: The key drivers include the increasing incidence of chronic diseases, an aging population, and advancements in healthcare infrastructure.

Q: How is mannitol used in the food and beverages sector? A: Mannitol is used as a low-calorie sweetener in the food and beverages sector, particularly in confectionery, mint-based sweets, and gums.

Q: What are the potential side effects of mannitol administration? A: Potential side effects include swelling, pain, itching, rash, or redness at the infusion site.

Sources

  1. IndustryARC: Mannitol Market 2020 - 2025[1]
  2. The Journal of Neurosurgery: Preclinical evaluation of transaxial intraputaminal trajectory for[2]
  3. Verified Market Research: In-Depth Industry Outlook: Mannitol Injection Market Size & Forecast[3]
  4. Future Market Insights: Mannitol Market Size, Share, Outlook & Forecast by 2033[4]
  5. Medicines.org.uk: INFORMATION FOR THE USER Mannitol 10% Solution for infusion BP[5]

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