Drugs in MeSH Category Tocolytic Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nephron	METAPROTERENOL SULFATE	metaproterenol sulfate	SOLUTION;INHALATION	071726-001	Jul 14, 1988		DISCN	No	No
Astrazeneca	YUTOPAR	ritodrine hydrochloride	INJECTABLE;INJECTION	018580-002	Sep 27, 1984		DISCN	No	No
Mutual Pharm	INDOMETHACIN	indomethacin	CAPSULE;ORAL	070067-001	Oct 3, 1986		DISCN	No	No
Mylan Labs Ltd	MAGNESIUM SULFATE IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	209911-002	Sep 14, 2018	AP	RX	No	No
Amneal	MAGNESIUM SULFATE IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	216597-001	Feb 15, 2023	AP	RX	No	No
Teva	NIFEDIPINE	nifedipine	CAPSULE;ORAL	072651-001	Feb 19, 1992		DISCN	No	No

Tocolytic Agents Market Analysis and Financial Projection

The global tocolytic agents market, valued for its role in managing preterm labor, is projected to grow at a 5.3% CAGR from 2023 to 2031, driven by rising preterm birth rates and advancements in drug development[1][6]. Prostaglandin inhibitors dominate the market due to their efficacy and safety profile, while North America leads regional growth due to high healthcare spending and technological innovation[1][4].

Market Dynamics

• Segmentation: The market is divided by drug class (magnesium sulfate, betamimetics, oxytocin antagonists, calcium channel blockers, prostaglandin inhibitors), route of administration (oral, parenteral), and region[1][6].
• Key Players: Fresenius Kabi AG, Pfizer Inc., and Merck & Co., Inc. are prominent players, leveraging partnerships to develop new agents[1][4].
• Challenges: Side effects (e.g., cardiovascular issues with beta-mimetics) and limited efficacy of existing drugs constrain adoption[1][14].

Patent Landscape

• Innovation: Patents like EP0132595A2 (tetrahydroisoquinoline derivatives) and WO2004009117A1 (EP2 agonists) highlight efforts to create safer, more effective tocolytics[2][7].
• Strategic Practices: Companies use "evergreening" and pediatric exclusivity extensions to prolong market control[5][9]. However, only 31–39% of drugs retain patent protection, with generics entering post-expiry[9].
• Cost Considerations: Indomethacin and nifedipine are cost-effective options compared to terbutaline and magnesium sulfate, influencing prescribing trends[15].

Clinical Insights

• Efficacy: Prostaglandin inhibitors and calcium channel blockers delay preterm labor by 48+ hours with fewer side effects, while magnesium sulfate shows limited benefit[3][14].
• Combination Therapies: Mixed results emerge, with some trials reporting increased adverse effects when combining ritodrine and magnesium[12].

Regional Trends

• North America: Leads due to high healthcare expenditure and R&D investment[1].
• Asia-Pacific: Emerging as a growth hub with increasing healthcare infrastructure and demand[1][6].

Future Outlook

• Opportunities: Development of targeted therapies and expanded access in underserved regions.
• Threats: Patent cliffs and generic competition post-2031 may reduce revenue for originator drugs[5][9].

"The proposed tocolytic agent can be taken in the form of tablets. It can also be introduced as a solution for injection or as a suppository."
– EP0132595A2 Patent[2]

In summary, the tocolytic agents market balances innovation against challenges like side effects and patent expirations, with prostaglandin inhibitors and strategic regional expansion shaping its trajectory.

References

1. https://www.growthplusreports.com/report/tocolytic-agents-market/8901
2. https://patents.google.com/patent/EP0132595A2/en
3. https://pubmed.ncbi.nlm.nih.gov/23048010/
4. https://www.openpr.com/news/3075767/tocolytic-agents-market-preserving-pregnancy-ensuring
5. https://www.pharmafocuseurope.com/articles/drug-patents-shape-pharma-competition
6. https://www.openpr.com/news/3049556/tocolytic-agents-market-statistical-forecast-trade-analysis
7. https://patents.google.com/patent/WO2004009117A1/en
8. https://en.wikipedia.org/wiki/List_of_MeSH_codes_(D27)
9. https://www.fdli.org/wp-content/uploads/2022/08/7-Darrow-and-Mai.pdf
10. https://pubchem.ncbi.nlm.nih.gov/compound/Terbutaline-hemisulfate
11. https://patents.justia.com/patent/7776557
12. https://www.cochrane.org/CD006169/PREG_combinations-of-tocolytic-drugs-for-inhibiting-preterm-labour
13. https://www.biorxiv.org/content/10.1101/2023.02.10.527980v3
14. https://pubmed.ncbi.nlm.nih.gov/8097367/
15. https://pubmed.ncbi.nlm.nih.gov/17904969/