Mechanism of Action: Dyes

Drugs with Mechanism of Action: Dyes

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Altaire Pharms Inc	ALTAFLUOR BENOX	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	208582-001	Dec 14, 2017		RX	Yes	Yes
Long Grove Pharms	AK-FLUOR 10%	fluorescein sodium	INJECTABLE;INTRAVENOUS	022186-001	Aug 8, 2008	AP	RX	Yes	Yes
Long Grove Pharms	AK-FLUOR 25%	fluorescein sodium	INJECTABLE;INTRAVENOUS	022186-002	Aug 8, 2008	AP	RX	Yes	Yes
Provepharm Sas	BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264-001	Jul 8, 2022		RX	Yes	Yes				Y
Provepharm Sas	BLUDIGO	indigotindisulfonate sodium	SOLUTION;INTRAVENOUS	216264-001	Jul 8, 2022		RX	Yes	Yes				Y

Dyes Market Analysis and Financial Projection

The market dynamics and patent landscape for drugs utilizing dyes as their mechanism of action reveal a sector shaped by innovation, regulatory challenges, and evolving therapeutic applications. Below is a structured analysis of key trends, drivers, and intellectual property considerations.

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Market Dynamics

Drivers

• Pharmaceutical Production Growth: Increased global demand for medicines has driven the need for pharmaceutical dyes, which help differentiate drugs visually and ensure accurate dosing[2][8].
• Natural Dye Adoption: Consumer preference for natural ingredients has spurred growth in organic/natural dyes (projected to reach $6.4 billion by 2029), particularly in North America and Europe[11].
• Therapeutic Applications: Dyes like isosulfan blue (lymphatic mapping) and phthalocyanine compounds (photodynamic cancer therapy) have expanded into diagnostic and treatment roles[3][5][17].

Restraints

• High Costs: Synthetic dye production faces volatile raw material prices (e.g., benzene), while natural dyes require costly extraction processes[8][11].
• Regulatory Constraints: Strict guidelines limit permissible dye types. For example, the FDA regulates colorants in pharmaceuticals and cosmetics, favoring non-toxic alternatives[11].

Trends

• Shift to Natural Dyes: Biodegradable options like annatto and turmeric are gaining traction due to safety and sustainability[18].
• Advanced Drug Delivery: Hydrogel-based systems and nanoparticle formulations (e.g., cisplatin nanoparticles) use dyes for targeted therapy, reducing side effects[9][14].

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Patent Landscape

Key Innovations

1. High-Purity Dyes: Patents like US 9,353,050 claim isosulfan blue formulations with ≥99% purity, critical for diagnostic accuracy[5][10].
2. Therapeutic Dyes:
   • US 7,662,992: Methods for synthesizing photodynamic agents (e.g., silicon phthalocyanine "La Jolla Blue")[3].
   • EP2214495A1: Natural dyes (e.g., turmeric) for photodynamic therapy to treat infections[18].
3. Imaging Dyes: US20160244614A1 covers near-infrared dyes for molecular imaging and cancer therapy[19].

Patent Trends

• Geographic Filings: The U.S. (412 patents) and China (373 patents) lead in cisplatin nanoparticle patents, reflecting regional R&D dominance[9].
• Success Rates: Only 0.02% of compounds in patent databases (e.g., SureChEMBL) reach approval, underscoring high attrition[1].
• Litigation: Cases like Mylan v. Aurobindo highlight disputes over synthesis methods and purity standards, emphasizing non-obviousness in patent claims[5][10].

Leading Assignees

Company/Institution	Focus Area	Notable Patents
Hangzhou Dac Biotech	Cisplatin nanoparticles	145 patents[9]
University of California	Hydrogel drug delivery	99 patents[14]
Apicore/Mylan	High-purity isosulfan blue	US 9,353,050[5]

Challenges

• Overlap Gaps: PubChem shares 91.5% of compounds with SureChEMBL, while ChEMBL overlaps only 0.1%, indicating divergent chemical spaces[1].
• Prior Art Hurdles: Patent disputes often center on prior art relevance (e.g., Sigma-Aldrich’s dye records deemed non-applicable to pharmaceuticals)[5].

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Future Outlook

The integration of dyes in drug delivery (e.g., hydrogels, nanoparticles) and diagnostics will drive innovation. However, scalability of natural dyes and regulatory harmonization remain critical hurdles. Litigation over synthesis methods and purity standards will likely intensify as competition grows[9][11][14].

Highlight: "The process of creating high purity isosulfan blue was its own patentable invention" [5].

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Key Takeaways

• Market growth hinges on natural dyes and advanced delivery systems.
• Patent success requires demonstrating novel synthesis or application beyond prior art.
• Regional R&D hotspots (U.S., China) dominate filings, with universities playing a significant role.

References

1. https://pmc.ncbi.nlm.nih.gov/articles/PMC11099139/
2. https://www.factmr.com/report/4036/pharmaceutical-dyes-market
3. https://patents.google.com/patent/US7005518B2/en
4. https://patents.google.com/patent/US20130137112A1/en
5. https://www.robinskaplan.com/newsroom/insights/mylan-institutional-llc-v-aurobindo-phama-ltd
6. https://www.nber.org/system/files/working_papers/w20492/revisions/w20492.rev0.pdf
7. https://pubmed.ncbi.nlm.nih.gov/1190249/
8. https://www.grandviewresearch.com/industry-analysis/dyes-and-pigments-market
9. https://origiin.com/patent-landscape-cisplatin-nanoparticle-formulation/
10. https://www.patentdocs.org/2017/05/mylan-institutional-llc-v-aurobindo-pharma-ltd-fed-cir-2017.html
11. https://www.marketsandmarkets.com/Market-Reports/natural-dyes-market-78173284.html
12. https://www.treatmentactiongroup.org/wp-content/uploads/2021/11/hcv_tb_longacting_patent_trends.pdf
13. https://www.biorxiv.org/content/biorxiv/early/2023/02/13/2023.02.10.527980.full.pdf
14. https://sagaciousresearch.com/blog/hydrogel-patent-trends-leading-innovators-top-jurisdictions-and-more/
15. https://www.biofiredefense.com/wp-content/uploads/2018/08/PressRelease-052803.pdf
16. https://www.thendobetter.com/investing/2021/3/9/why-1857-french-patent-law-made-basel-wealthy-and-birthed-swiss-pharmaceuticals
17. https://pmc.ncbi.nlm.nih.gov/articles/PMC4811612/
18. https://patents.google.com/patent/EP2214495A1/en
19. https://patents.google.com/patent/US20160244614A1/en
20. https://go.drugbank.com/drugs/DB13967