Nitrogen Binding Agent Drug Class List

Drugs in Drug Class: Nitrogen Binding Agent

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ailex Pharms Llc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	207096-001	Feb 24, 2016	AP	RX	No	Yes
Endo Operations	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	POWDER;ORAL	203918-001	Jun 15, 2016	AB	RX	No	No
Endo Operations	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	TABLET;ORAL	204395-001	Apr 15, 2016	AB	RX	No	No
Glenmark Pharms Ltd	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	TABLET;ORAL	216462-001	Nov 1, 2022	AB	RX	No	No
Maia Pharms Inc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	208521-001	May 8, 2017	AP	RX	No	No
Maia Pharms Inc	SODIUM PHENYLACETATE AND SODIUM BENZOATE	sodium benzoate; sodium phenylacetate	SOLUTION;INTRAVENOUS	215025-001	Jun 10, 2021	AP	RX	Yes	Yes
Sigmapharm Labs Llc	SODIUM PHENYLBUTYRATE	sodium phenylbutyrate	POWDER;ORAL	202819-001	Mar 22, 2013	AB	RX	No	No

Nitrogen Binding Agent Market Analysis and Financial Projection

The market dynamics and patent landscape for nitrogen-binding agents, particularly in pharmaceuticals, reflect a complex interplay of innovation, regulatory strategies, and evolving therapeutic needs. Below is a detailed analysis:

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Market Dynamics

Growth Drivers

1. Rising Demand for Rare Disease Treatments:
   Nitrogen-binding agents like glycerol phenylbutyrate (Ravicti®) are critical for managing urea cycle disorders (UCDs), which affect ~1 in 35,000 newborns[18]. Increased awareness and improved diagnostics are driving market expansion. The global Ravicti market is projected to grow at a CAGR of 6.8–26.2%, reaching $556.5M–$1.05B by 2030–2031[13][15].

2. Geographic Expansion:

   • North America dominates (>40% market share) due to advanced healthcare infrastructure and high treatment adoption[14][15].
   • Asia-Pacific is the fastest-growing region (CAGR 28.2%)[15], fueled by increasing healthcare spending and awareness of rare disorders.

3. Pipeline Innovation:
   Research into nitrogen mustard derivatives (e.g., cyclophosphamide) continues, with efforts to improve selectivity and reduce toxicity[3][7]. Repurposing existing drugs for oncology and neurodegenerative diseases presents additional growth avenues[8].

Challenges

• High Costs: Drug development for rare diseases is expensive (~$2.6B per drug)[16], limiting accessibility.
• Regulatory Hurdles: Stringent approval processes delay market entry for generics and novel agents[16].

Competitive Landscape

• Key Players: Horizon Pharma (Ravicti®) holds a dominant position with extended patent protection until 2032[17][19].
• Generic Threats: Par Pharmaceutical successfully challenged Horizon’s patents in 2016[20], signaling future competition post-2032. Currently, only one generic API supplier exists[19].

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Patent Landscape

Key Strategies

1. Orange Book Listings:
   Horizon Pharma secured 9 Orange Book patents for Ravicti®, covering synthesis, formulations, and therapeutic monitoring[17]. The last patent expires in 2032, delaying generic entry[19].

2. Innovation Tracks:

   • Formulation Patents: Focus on liquid/solid dosage forms and polymorphs to extend exclusivity (e.g., Ritonavir’s patent strategy)[1].
   • Method-of-Use Patents: Claims on dosing regimens and metabolic monitoring[17].

3. Litigation Risks:
   Paragraph IV certifications and inter partes reviews (e.g., Par Pharma’s PTAB victory in 2016)[20] highlight vulnerabilities in patent portfolios.

Regional Trends

• North America: High patent activity due to robust R&D investment.
• Europe/Asia: Growing filings in synthesis intermediates and agricultural applications (e.g., nitrogen-fixing fertilizers)[5][6][10].

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Key Market Segments

Segment	Key Insights
Therapeutic	UCD treatment (Ravicti®) dominates; oncology applications emerging[3][7].
Formulations	Liquid dosage forms (25mL/50mL) lead due to patient compliance[15].
Geography	North America (>40% share), Asia-Pacific (fastest growth)[15].

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Future Outlook

• Collaborations: Public-private partnerships and AI-driven drug discovery could accelerate repurposing efforts[8].
• Patent Expiries: Post-2032, generics may capture 30–40% market share, depending on litigation outcomes[19][20].
• Sustainability Focus: Growth in nitrogen-fixing fertilizers (CAGR 7.2% by 2029)[10] reflects cross-industry demand for nitrogen management.

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Highlight:
"Horizon Pharma’s strategic patent filings for Ravicti® exemplify the balance between innovation and market protection in rare disease therapeutics"[17].

In summary, the nitrogen-binding agent market is shaped by rare disease demand, patent strategies to delay generics, and regional healthcare advancements. While Horizon Pharma currently leads, regulatory and competitive pressures will reshape dynamics post-2032.

References

1. https://www.wipo.int/edocs/pubdocs/en/patents/946/wipo_pub_946.pdf
2. https://www.procurementresource.com/resource-center/nitrogen-price-trends
3. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2018.01453/full
4. https://www.fdli.org/wp-content/uploads/2022/08/7-Darrow-and-Mai.pdf
5. https://patents.google.com/patent/US20210068400A1/en
6. https://straitsresearch.com/report/liquid-nitrogen-market
7. https://www.mdpi.com/2227-9717/9/2/377
8. https://patentpc.com/blog/patent-implications-of-drug-repurposing
9. https://patents.google.com/patent/US20160046539A1/en
10. https://www.databridgemarketresearch.com/reports/global-nitrogen-fixing-fertilizer-market
11. https://go.drugbank.com/categories/DBCAT000269
12. https://drugdocs.com/class/nitrogen-binding-agents
13. https://reports.valuates.com/market-reports/QYRE-Auto-37X833/global-ravicti
14. https://www.youtube.com/watch?v=6ijtZ4QlCNE
15. https://www.cognitivemarketresearch.com/ravicti-market-report
16. https://www.verifiedmarketreports.com/product/glycerol-phenylbutyrate-market/
17. https://www.einpresswire.com/article/445992427/horizon-pharma-plc-announces-the-u-s-patent-and-trademark-office-issuance-of-additional-notices-of-allowance-with-claims-covering-ravicti-glycerol
18. https://www.datamintelligence.com/research-report/urea-cycle-disorder-treatment-market
19. https://pharsight.greyb.com/drug/ravicti-patent-expiration
20. https://www.axinn.com/en/insights/news/Par_IPR_Victory_Horizon_Ravicti