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Last Updated: April 25, 2025

Drugs in MeSH Category Tocolytic Agents


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

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/

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