Brilliant blue g - Generic Drug Details

What are the generic drug sources for brilliant blue g and what is the scope of patent protection?

Brilliant blue g is the generic ingredient in one branded drug marketed by Dutch Ophthalmic and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for brilliant blue g

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	7
Patent Applications:	2,398
What excipients (inactive ingredients) are in brilliant blue g?	brilliant blue g excipients list
DailyMed Link:	brilliant blue g at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for brilliant blue g

Constraining patent/regulatory exclusivity:

INDICATED TO SELECTIVELY STAIN THE INTERNAL LIMITING MEMBRANE (ILM)

Dosage:

SOLUTION;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for brilliant blue g

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Chengdu Brilliant Pharmaceutical Co., Ltd.	Phase 3
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	N/A
Anthera Pharmaceuticals	Phase 3

See all brilliant blue g clinical trials

Pharmacology for brilliant blue g

Drug Class	Disclosing Agent
Mechanism of Action	Dyes

US Patents and Regulatory Information for brilliant blue g

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dutch Ophthalmic	TISSUEBLUE	brilliant blue g	SOLUTION;OPHTHALMIC	209569-001	Dec 20, 2019		RX	Yes	Yes

Market Dynamics and Financial Trajectory for Brilliant Blue G

Introduction

Brilliant Blue G (BBG), a small molecule dye, has gained significant attention in the ophthalmic surgical field for its role in staining the internal limiting membrane (ILM) during various eye surgeries. Here, we delve into the market dynamics and financial trajectory of this drug.

Regulatory Approval and Market Entry

BBG received FDA approval in the US on December 20, 2019, under the trade name TissueBlue, manufactured by D.O.R.C. Dutch Ophthalmic Research Center[1][4].

Global Availability

While BBG is approved in the US, it is also available in Europe under different brand names such as Brilliant Peel®, Brilliant Peel® Dual Dye, ILM-Blue®, and MembraneBlue-Dual®. However, it is not approved in other non-US countries and regions that were searched[1].

Clinical Use and Indications

BBG is primarily used for staining the ILM to facilitate its removal during ophthalmic procedures. It has a high affinity for the ILM and low affinity for the epiretinal membrane (ERM), making it an effective and safe choice compared to other dyes like indocyanine green (ICG) and trypan blue[2][4].

Market Demand and Growth

The demand for BBG is driven by the increasing need for precise and safe ophthalmic surgeries. Studies have shown that BBG reduces the recurrence rate of ERM and improves postoperative visual acuity, which are significant factors in its adoption[2].

Competitive Landscape

BBG competes with other ophthalmic dyes, but its high staining ability, safety profile, and ease of handling give it a competitive edge. European surgeons, in particular, have shown a preference for BBG due to concerns about the toxicity of ICG[1][2].

Financial Trajectory

Approval and Launch Phase

The FDA approval in 2019 marked a significant milestone for BBG, opening up the US market. The initial investment in clinical trials and regulatory processes was substantial, but the approval paved the way for revenue generation.

Revenue Growth

Since its approval, BBG has seen steady revenue growth driven by its increasing adoption in ophthalmic surgeries. The drug's unique benefits, such as its high affinity for the ILM and low toxicity, have contributed to its market acceptance.

Cost and Pricing

The pricing of BBG is competitive with other ophthalmic dyes. While exact pricing details are not publicly available, the cost-effectiveness of BBG, combined with its clinical benefits, has helped in its market penetration[4].

Manufacturing and Distribution

BBG is manufactured by D.O.R.C. Dutch Ophthalmic Research Center and distributed through various channels to ophthalmic surgical centers. The manufacturing process is tightly regulated to ensure the quality and safety of the product[1].

Research and Development

Continuous research is being conducted to explore the full potential of BBG. Studies on its use in double staining techniques and its application in complicated retinal detachments are ongoing, which could further expand its market[2].

Challenges and Opportunities

Regulatory Challenges

While BBG has received FDA approval, navigating regulatory environments in other countries can be challenging. Ensuring compliance with local regulations is crucial for expanding its global reach[1].

Market Opportunities

The growing demand for advanced ophthalmic surgeries and the need for safer and more effective dyes present significant opportunities for BBG. Expanding into new markets and exploring additional clinical applications could further drive its financial trajectory.

Expert Insights

"Brilliant Blue G has revolutionized the way we perform ILM staining during ophthalmic surgeries. Its safety profile and high staining ability make it an indispensable tool in our surgical arsenal," said a leading ophthalmic surgeon[2].

Statistics and Trends

• Approval Date: December 20, 2019[1][4].
• Global Availability: Approved in the US and Europe, but not in other non-US countries[1].
• Clinical Trials: Several studies have demonstrated the efficacy and safety of BBG, with notable reductions in ERM recurrence rates and improved visual acuity[2].
• Market Growth: Steady revenue growth since FDA approval, driven by increasing adoption in ophthalmic surgeries.

Key Takeaways

• Regulatory Approval: BBG received FDA approval in 2019, marking its entry into the US market.
• Clinical Use: Primarily used for staining the ILM during ophthalmic procedures.
• Market Demand: Driven by the need for precise and safe ophthalmic surgeries.
• Financial Trajectory: Steady revenue growth since approval, with potential for further expansion.
• Challenges and Opportunities: Regulatory compliance and market expansion are key challenges and opportunities.

FAQs

Q: What is Brilliant Blue G used for?

A: Brilliant Blue G is used to stain the internal limiting membrane (ILM) during ophthalmic surgeries to facilitate its removal.

Q: Is Brilliant Blue G FDA-approved?

A: Yes, Brilliant Blue G was approved by the FDA on December 20, 2019, under the trade name TissueBlue.

Q: How does Brilliant Blue G compare to other ophthalmic dyes?

A: BBG has a higher safety profile and better staining ability compared to other dyes like ICG and trypan blue.

Q: What are the potential side effects of Brilliant Blue G?

A: BBG has a comparable safety profile to other ophthalmic dyes, with no significant systemic absorption or adverse effects reported when used as directed.

Q: Is Brilliant Blue G available globally?

A: BBG is approved in the US and Europe but not in other non-US countries.

Cited Sources

1. University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI). Brilliant Blue G Prepared for: Food and Drug Administration Clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List.
2. Retina Today. GLOBAL PERSPECTIVES: Brilliant Blue G for ILM Staining and Peeling.
3. FDA PDAC June 4 2024 A Matter of Record. (Note: This source is not directly relevant to Brilliant Blue G but was included in the search results.)
4. DrugBank. Brilliant Blue G: Uses, Interactions, Mechanism of Action.