Drugs in MeSH Category Sweetening Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun	SORBITOL 3.3% IN PLASTIC CONTAINER	sorbitol	SOLUTION;IRRIGATION	016741-001	Approved Prior to Jan 1, 1982		RX	No	No
B Braun	MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER	mannitol	INJECTABLE;INJECTION	016080-006	Approved Prior to Jan 1, 1982		DISCN	No	No
Fresenius Kabi Usa	MANNITOL 25%	mannitol	INJECTABLE;INJECTION	080677-001	Approved Prior to Jan 1, 1982	AP	RX	No	No
Hospira	MANNITOL 5%	mannitol	INJECTABLE;INJECTION	016269-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Igi Labs Inc	MANNITOL 25%	mannitol	INJECTABLE;INJECTION	089239-001	May 6, 1987		DISCN	No	No
Luitpold	MANNITOL 25%	mannitol	INJECTABLE;INJECTION	087409-001	Jan 21, 1982		DISCN	No	No
Watson Labs	MANNITOL 25%	mannitol	INJECTABLE;INJECTION	087460-001	Jun 27, 1983		DISCN	No	No

Sweetening Agents Market Analysis and Financial Projection

The global market for sweetening agents is experiencing robust growth driven by health trends, regulatory shifts, and technological advancements, with pharmaceuticals emerging as a key innovation hub. Below is an analysis of market dynamics and patent trends for drugs in this category:

---

Market Dynamics

Growth Projections

• The sugar substitutes market grew from $13.53B (2023) to $14.24B (2024), projected to reach $19.88B by 2030 at a 5.64% CAGR[2].
• Natural sweeteners are expanding faster, expected to rise from $24.7B (2023) to $45.1B by 2033 (6.2% CAGR), driven by clean-label demands and diabetes concerns[8][16].
• Pharmaceuticals account for the fastest-growing segment (3.3% CAGR), leveraging sweeteners to improve drug palatability[11].

Key Drivers

1. Health Consciousness: Rising diabetes/obesity rates and sugar-linked health risks[8][16].
2. Regulatory Pressures: Policies promoting sugar reduction and transparency in labeling[2][8].
3. Pharmaceutical Demand: Sweeteners mask bitterness in medications (e.g., antibiotics, antivirals) and enhance compliance in pediatric/geriatric formulations[6][10][12].

Regional Trends

• Asia-Pacific dominates natural sweeteners (32.8% market share), fueled by urbanization and dietary shifts in India and China[8].
• North America prioritizes low-calorie alternatives, supported by FDA approvals for agents like acesulfame potassium and sucralose[16].

---

Patent Landscape

Innovation Trends

• Stevia Formulations: Recent patents focus on improving solubility (e.g., Stevia Sweetener with Improved Solubility with a Cyclodextrin) and stabilizing taste profiles[5].
• Multi-Agent Blends: Pharmaceutical patents (e.g., US8501219B2, US6911214B2) combine high fructose corn syrup, glycerin, saccharin, and acesulfame potassium to optimize sweetness and shelf stability[4][9].
• Taste Masking: Compositions like sucralose in US6806256B2 suppress bitterness in antibiotics and antivirals [10][15].

Key Patents

Patent	Innovation Focus	Application Example
US3492131A	Aspartame derivatives (100–200x sweeter than sucrose)	Diabetes-friendly sweeteners[3]
US7122198	Fast-dissolving tablets with slow-release sweeteners	Pediatric medications[12]
WO2002072102A1	Sucralose-based masking for bitter drugs	Liquid antibiotic formulations[15]

Geographical IP Activity

• China leads with 6,600+ patents, followed by the US (2,700+) and Japan (2,000+)[5].
• Strategic litigation (e.g., TC Heartland v. Kraft) highlights competitive stakes in sweetener IP[5].

---

Technological and Regulatory Synergy

• Natural Alternatives: Stevia and monk fruit extract dominate recent R&D, aligning with consumer preferences for non-synthetic options[5][8].
• Pharmaceutical Formulations: Advances in mucoadhesive sweeteners (e.g., US7122198) extend drug release while masking bitterness[12].
• Regulatory Pathways: FDA requirements for biosimilars (e.g., ABP 654’s approval process) influence IP strategies for biologics[13][14].

---

Key Takeaway: The sweetening agents market is transitioning toward natural, multi-functional solutions, with patents reflecting cross-industry demand for healthier alternatives and patient-centric drug delivery. Companies prioritizing synergistic blends and global IP diversification are best positioned to capitalize on this growth.

References

1. https://www.ncbi.nlm.nih.gov/mesh/68013549
2. https://www.globenewswire.com/news-release/2025/03/13/3042096/28124/en/Sugar-Substitutes-Market-Analysis-Report-2025-2030-Sustainability-and-Innovation-are-the-Twin-Pillars-of-Growth.html
3. https://patents.google.com/patent/US3492131A/en
4. https://patents.google.com/patent/US8501219B2/en
5. https://www.ktmine.com/sugar-substitutes-sweetening-food-patent-portfolios/
6. https://pmc.ncbi.nlm.nih.gov/articles/PMC9323338/
7. https://en.wikipedia.org/wiki/Medical_Subject_Headings
8. https://www.globenewswire.com/news-release/2024/01/24/2814777/0/en/Natural-Sweeteners-Market-Indicating-a-Valuation-Exceeding-USD-45-1-Billion-by-2033-Riding-on-a-Strong-6-2-CAGR-Market-us.html
9. https://patents.google.com/patent/US6911214B2/en
10. https://patents.google.com/patent/US6806256B2/en
11. https://www.grandviewresearch.com/industry-analysis/sweeteners-market-report
12. https://patents.justia.com/patent/7122198
13. https://www.biosimilarsip.com/wp-content/uploads/sites/768/2023/05/First-Amended-Complaint_3.7.2023.pdf
14. https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity
15. https://patents.google.com/patent/WO2002072102A1/en
16. https://www.marketsandmarkets.com/Market-Reports/sweeteners-market-186278129.html