Mechanism of Action: Radiopharmaceutical Activity

Drugs with Mechanism of Action: Radiopharmaceutical Activity

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Petnet	AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	204510-001	Nov 2, 2015	AP	RX	No	No
Precision Nuclear	AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	204547-001	Aug 14, 2015	AP	RX	No	No
Univ Tx Sw Medctr	AMMONIA N 13	ammonia n-13	INJECTABLE;INTRAVENOUS	209507-001	Nov 1, 2019	AP	RX	No	No

Radiopharmaceutical Activity Market Analysis and Financial Projection

The radiopharmaceutical market is experiencing rapid growth and transformation, driven by technological advancements, increasing prevalence of chronic diseases, and strategic patenting activities. Here's an in-depth analysis of the market dynamics and patent landscape:

Market Growth Projections

• Explosive Expansion: Multiple reports indicate substantial growth, with estimates ranging from $14.38 billion by 2032 (9.8% CAGR)[3][10] to $26.51 billion by 2031 (14.4% CAGR)[1]. Discrepancies stem from varying methodologies and regional focus, but all agree on double-digit growth trajectories.
• Key Drivers:
  • Rising cancer and Alzheimer's cases (6.9M+ Alzheimer's patients in the U.S. alone)[3].
  • Adoption of theragnostics (combined diagnostics/therapy), now accounting for 30% of pipeline products[1][6].
  • AI integration in drug development, improving target identification and personalized dosing[1][6].

Regional Dynamics	Region	Market Share (2023)	Growth Driver
North America	44-47%[1][14]	Advanced healthcare infrastructure, favorable reimbursement
Asia-Pacific	22% (fastest-growing)[1]	Aging population, $1.2B+ VC investments (2019–2022)[5]
Europe	2nd largest[14]	Mergers like Sanofi-Orano Med ($100M deal)[13]

Patent Landscape and Innovation

• Surge in Filings: Global patent families increased to 16,775 (2005–2023), with a sharp rise post-2021[2]. Key IPC codes:
  • A61K51: Radioactive therapeutic preparations (33% U.S.-filed)[2]
  • A61K51/04: Organic compound conjugates (e.g., Lu-177-PSMA)[2]

Strategic Patenting Trends

• Multi-layered Protection: Companies are securing IP for:

  • Novel isotopes (e.g., 225Ac for alpha therapy)[5]
  • Formulation improvements (e.g., oxygen-resistant 99mTc-tetrofosmin)[4]
  • Combination therapies (radioisotope + immunotherapy)[1]

• Geographic Shifts: While the U.S. leads (33% of filings)[2], China now files 67% of recent 99mTc patents[4], targeting PD-L1/HER2 biomarkers.

Top Innovators

1. Novartis: 177Lu-DOTATATE (Lutathera®) and Pluvicto® driving $2B+ acquisitions[13]
2. Australian Startups: Telix & Clarity Pharmaceuticals dominating 68% of local filings[2]
3. Academic Institutions: Dana-Farber Cancer Institute leading covalent drug patents[9]

Challenges and Opportunities

• Supply Chain Pressures:

  • Actinium-225 demand exceeds supply by 600% (200K doses needed vs. 2K available)[5].
  • Solutions: TerraPower's 229Th decay harvesting (600K doses/year potential)[5].

• Regulatory Hurdles:

  • CMS proposed expanded reimbursement in 2024[13].
  • Transport restrictions for radioactive materials hinder distribution[13].

Investment Trends

• VC funding in U.S. radiopharma surged 550% (2017–2023)[8].
• Recent M&A includes Lilly's $1.1B Aktis Oncology deal and AstraZeneca's $2B Fusion Pharma acquisition[13].

Future Outlook

• Production Scaling: PanTera's $140M expansion for 225Ac[13] and Tri-Lab U.S. initiatives aim to address isotope shortages[5].
• Next-Gen Targets:
  • Fibroblast Activation Protein (FAP) inhibitors in Phase I[13]
  • KRAS G12C covalent modulators (186 patents filed)[9]

"The radiopharmaceutical field is no exception to the rule that commercial success requires strategic IP layering." – FB Rice Patent Analysis[2]

As the market evolves, success will depend on navigating complex IP landscapes, securing isotope supply chains, and adapting to AI-driven personalized medicine paradigms. Companies combining robust patent portfolios with scalable production (e.g., Novartis’s Pluvicto manufacturing network[13]) are best positioned to lead this $26B+ revolution in targeted therapy.

References

1. https://www.pharmexec.com/view/report-radiopharmaceutical-market-expected-reach-26-51-billion-2031
2. https://www.fbrice.com.au/ip-news-insights/the-global-renaissance-of-radiopharmaceuticals/
3. https://www.gminsights.com/industry-analysis/radiopharmaceuticals-market
4. https://pubs.acs.org/doi/10.1021/acs.jmedchem.3c00148
5. https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.1070497/full
6. https://straitsresearch.com/report/radiopharmaceutical-market
7. https://pmc.ncbi.nlm.nih.gov/articles/PMC6896597/
8. https://synapse-patsnap-com.libproxy1.nus.edu.sg/organization/2bee6c6ef7c3c6168147f53a8a4cf7f6
9. https://pubmed.ncbi.nlm.nih.gov/39219095/
10. https://www.fnfresearch.com/radiopharmaceutical-market-report
11. https://link.epo.org/web/publications/studies/en-patents-and-innovation-against-cancer-study.pdf
12. https://parolaanalytics.com/lr/2023-us-pharmaceuticals-patent-landscape-report/
13. https://www.pharmaceutical-technology.com/features/radiopharmaceutical-deals-drive-sector-growth-despite-supply-crisis/
14. https://market.us/report/radiopharmaceutical-market/