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

Last Updated: December 22, 2024

MANNITOL 15% Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Mannitol 15% patents expire, and when can generic versions of Mannitol 15% launch?

Mannitol 15% is a drug marketed by B Braun, Hospira, Miles, and Icu Medical Inc. and is included in five NDAs.

The generic ingredient in MANNITOL 15% 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.

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for MANNITOL 15%?
  • What are the global sales for MANNITOL 15%?
  • What is Average Wholesale Price for MANNITOL 15%?
Summary for MANNITOL 15%
Drug patent expirations by year for MANNITOL 15%
Recent Clinical Trials for MANNITOL 15%

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

SponsorPhase
University Hospital, GenevaPhase 3
Morten Hostrup, PhDN/A
Ecole Polytechnique Fédérale de LausanneEarly Phase 1

See all MANNITOL 15% clinical trials

Pharmacology for MANNITOL 15%
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for MANNITOL 15%

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 15% mannitol INJECTABLE;INJECTION 016080-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun MANNITOL 15% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006-003 Jul 26, 1993 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira MANNITOL 15% mannitol INJECTABLE;INJECTION 016269-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Miles MANNITOL 15% mannitol INJECTABLE;INJECTION 016472-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% mannitol INJECTABLE;INJECTION 016080-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Icu Medical Inc MANNITOL 15% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603-003 Jan 8, 1990 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 15%

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 15% Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mannitol 15%

Market Size and Growth Projections

The global mannitol market, which includes the 15% solution, has been experiencing significant growth and is projected to continue this trend. In 2022, the market size was estimated to be around USD 418.65 million[1][3][4].

  • By 2033, the market is expected to reach USD 890.31 million, growing at a Compound Annual Growth Rate (CAGR) of 7.1% from 2023 to 2033[1].
  • Another forecast suggests that the market will reach USD 754.70 million by 2031, with a CAGR of 6.8% from 2024 to 2031[3].

Key Drivers of Growth

Increasing Health Consciousness

The rising health consciousness among consumers, particularly the demand for low-calorie and non-cariogenic food additives, is driving the growth of the mannitol market. Mannitol is favored for its ability to act as a sweetener without significantly increasing blood glucose levels, making it a popular choice for health-conscious consumers[1][3].

Growing Prevalence of Diabetes

The increasing incidence of diabetes globally is a significant factor. In countries like Brazil, where nearly 14.3 million adults were living with diabetes in 2015, the demand for sugar substitutes like mannitol is on the rise. This trend is expected to continue, driving the market forward[1].

Pharmaceutical Applications

Mannitol is widely used in the pharmaceutical industry as an excipient in the formulation of pharmaceutical products and as a treatment for brain, kidney, and heart problems. Its use as a bulking agent in tableting applications further supports market growth[1][3].

Regional Market Dynamics

Asia Pacific

China is expected to dominate the Asia Pacific market, accounting for over 52.9% of the region's market share in 2023. The country's growing food and beverage sector and its position as the world's leading producer of sugar alternatives are key drivers[1].

Latin America

Brazil is among the fastest-growing countries in Latin America, expected to account for over 35.5% of mannitol consumption in the region by 2033. High rates of obesity and type 2 diabetes in Brazil have led to increased demand for sugar substitutes like mannitol[1].

North America and Europe

North America is expected to hold the largest revenue share due to the increasing prevalence of acute renal failure and trauma, as well as the use of mannitol to reduce intracranial pressure and treat cerebral edema. Europe also sees significant demand, particularly for the treatment of cystic fibrosis[4].

Product Type and Application

Product Type

The global market is segmented by product type, with the 20g/100 ml concentration expected to represent the largest revenue share. This is due to the rising solution of Mannitol 20% for treating conditions such as increased intracranial pressure, glaucoma, and advanced diuresis in patients with renal failure[4].

Application

Mannitol is used in various applications, including hospital pharmacies, retail pharmacies, and online pharmacies. The pharmaceutical and food industries are the primary sectors driving demand, with mannitol being used as an excipient and a sweetener[4].

Technological Advances

Recent technological advances in synthesizing mannitol using less expensive raw materials, such as lactic acid bacteria, are expected to boost production yield while maintaining high purity quality. This innovation is likely to support market growth over the next few years[3].

Financial Performance and Projections

  • The cost of product revenues for mannitol, excluding amortization of intangibles, is expected to increase with rising sales volumes. For instance, the cost of product revenues for a related pharmaceutical company increased from $55.1 million in 2022 to $65.6 million in 2023, reflecting increased sales volumes[5].

  • The overall revenue growth is expected to be robust, with the market projected to more than double in the next decade. This growth is supported by increasing demand from both the pharmaceutical and food industries.

Challenges and Opportunities

Challenges

The market faced challenges during the pandemic, with production lines closed and lockdowns impacting supply chains. However, as economies recover, the market is expected to rebound. Economic conditions in severely impacted countries may still pose a challenge to market growth[4].

Opportunities

The growing focus on health and wellness, particularly in the wake of the pandemic, presents significant opportunities for the mannitol market. The increasing demand for natural and organic food items and the need for sugar substitutes are key drivers of growth[1][3].

Key Takeaways

  • The global mannitol market is projected to grow significantly, driven by increasing health consciousness, the growing prevalence of diabetes, and pharmaceutical applications.
  • Regional markets, particularly in Asia Pacific and Latin America, are expected to see substantial growth.
  • Technological advances in production are likely to enhance market growth.
  • Despite challenges posed by the pandemic, the market is expected to rebound strongly.

FAQs

Q: What is the current market size of the global mannitol market?

  • The global mannitol market was estimated to be around USD 418.65 million in 2022[1].

Q: What is the projected CAGR for the mannitol market from 2023 to 2033?

  • The market is expected to grow at a CAGR of 7.1% from 2023 to 2033[1].

Q: Which region is expected to dominate the mannitol market in Asia Pacific?

  • China is expected to dominate the Asia Pacific market, accounting for over 52.9% of the region's market share in 2023[1].

Q: What are the primary applications of mannitol?

  • Mannitol is used as an excipient in pharmaceutical products, as a treatment for brain, kidney, and heart problems, and as a sweetener in the food industry[1][3].

Q: How has the pandemic impacted the mannitol market?

  • The pandemic impacted the market by closing production lines and imposing lockdowns, but the market is expected to recover as economies reopen[4].

Cited Sources

  1. Future Market Insights: Mannitol Market Size, Share, Outlook & Forecast by 2033.
  2. Insmed: Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides Business Update.
  3. SkyQuestT: Mannitol Market Growth, Size & Share Analysis | 2031.
  4. SNS Insider: Mannitol Market Size & Share Report Forecast 2023-2030.
  5. Insmed Investor Relations: Insmed Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides Business Update.

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.