BSS PLUS Drug Patent Profile

When do Bss Plus patents expire, and what generic alternatives are available?

Bss Plus is a drug marketed by Alcon and is included in one NDA.

The generic ingredient in BSS PLUS is calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate. There are two hundred and eighty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate profile page.

Summary for BSS PLUS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	168
What excipients (inactive ingredients) are in BSS PLUS?	BSS PLUS excipients list
DailyMed Link:	BSS PLUS at DailyMed

US Patents and Regulatory Information for BSS PLUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon	BSS PLUS	calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018469-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

Expired US Patents for BSS PLUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon	BSS PLUS	calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018469-001	Approved Prior to Jan 1, 1982	4,443,432
Alcon	BSS PLUS	calcium chloride; dextrose; glutathione disulfide; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018469-001	Approved Prior to Jan 1, 1982	4,550,022

International Patents for BSS PLUS

See the table below for patents covering BSS PLUS around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	3275975
Ireland	54082	OPHTHALMIC IRRIGATING SOLUTION
Ireland	822327

Supplementary Protection Certificates for BSS PLUS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0933372	SPC/GB08/018	United Kingdom		PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
2365988	122018000012	Germany		PRODUCT NAME: PATIROMER SORBITEX CALCIUM UND SALZE DAVON IN ALLEN VOM GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286	122018000145	Germany		PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719

BSS PLUS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: BSS PLUS

Introduction

The pharmaceutical industry is undergoing significant changes, driven by innovative pricing models, regulatory pressures, and consumer demand for transparency and affordability. One drug that has been impacted by these dynamics is BSS PLUS, a sterile ophthalmic solution. Here, we will explore the market dynamics and financial trajectory of BSS PLUS, particularly in the context of emerging cost-plus drug pricing models.

Market Context: Pharmaceutical Pricing Models

Traditional Pricing Models

Traditionally, pharmaceutical pricing has been complex, involving multiple stakeholders such as manufacturers, pharmacy benefits managers (PBMs), and insurers. This complexity often leads to high markups and opaque pricing, making it difficult for consumers to understand the true cost of their medications[4].

Emerging Cost-Plus Models

Cost-plus drug pricing models, popularized by initiatives like Mark Cuban's Cost Plus Drug Company, aim to simplify and reduce drug costs. These models eliminate excessive markups by charging a flat markup over the cost of the drug, plus pharmacy fees. For example, Cost Plus Drugs charges a flat 15% markup over its cost, plus pharmacy fees[1][4].

Impact on BSS PLUS

Pricing Transparency

The adoption of cost-plus models could significantly impact the pricing of BSS PLUS. By providing transparent pricing based on the actual cost of the drug, these models can reduce the financial burden on consumers. For instance, if a cost-plus model were applied to BSS PLUS, the price would be determined by the drug's cost plus a fixed markup and pharmacy fees, rather than the current complex pricing structure[4].

Consumer Savings

Studies and pilot programs have shown that cost-plus models can lead to substantial savings for consumers. For example, a pilot program between Walgreens and RxSense saved customers nearly $70 million on their prescriptions over 11 months. Similar savings could be anticipated for BSS PLUS if it were included in such programs[4].

Payer Perspectives

Interest and Concerns

Payers are divided on the adoption of cost-plus models. While 33% of payers are very interested in partnering with companies like Cost Plus Drugs, an equal number are not interested. The primary concerns include the business model's non-inclusion of most insurance benefits and the potential for confusion among patients regarding their drug costs[1].

Cost Savings and Drug Availability

For payers to consider partnering with cost-plus models, significant cost savings and drug availability are crucial. For instance, 67% of payers consider member cost and 50% consider drug availability as "very important" factors. If BSS PLUS were to be included in a cost-plus model, demonstrating substantial cost savings and ensuring wide availability would be essential for gaining payer support[1].

Financial Trajectory

Revenue Impact

The financial trajectory of BSS PLUS under a cost-plus model would likely involve a reduction in revenue per unit sold, as the pricing would be more transparent and lower. However, this could be offset by increased volume sales due to the drug's newfound affordability. Companies like CVS Health, with their new CostVantage program, anticipate stable and predictable earnings despite the shift to a more transparent pricing model[4].

Market Share

The adoption of cost-plus models could lead to an increase in market share for BSS PLUS, as more consumers and payers opt for transparent and affordable pricing. This shift could also pressure traditional PBMs to work with cost-plus models, further expanding the drug's reach[1][4].

Regulatory and Competitive Landscape

Regulatory Pressure

Regulatory bodies, states, and the federal government are increasingly pressuring PBMs to deliver more transparent pricing and lower costs. This pressure is driving major retailers like CVS and Walgreens to adopt new pricing models, which could benefit drugs like BSS PLUS by making them more accessible and affordable[4].

Competitive Strategies

Competitors in the pharmaceutical industry are also adopting innovative strategies to reduce costs and increase transparency. For example, CVS Health's Caremark TrueCost program offers clients more visibility into prescription drug pricing and administrative fees. Such initiatives could set a new standard for the industry, influencing how drugs like BSS PLUS are priced and marketed[4].

Value-Based Pricing Considerations

Economic and Cost Aspects

Value-based pricing models emphasize economic and cost aspects, such as return on investment, willingness-to-pay, and country-specific pricing characteristics. For BSS PLUS, these elements would need to be carefully considered to ensure that the drug's price reflects its value to patients and society. This could involve quantifying the weights of relevant elements in the drug value framework and observing their interlinkages over time[3].

Patient and Societal Benefits

The value of BSS PLUS should also reflect its benefits to patients and society. Elements such as disease characteristics, patient characteristics, and healthcare process benefits are crucial in determining the drug's value. Ensuring that the pricing model accounts for these factors can help in establishing a coherent and acceptable framework for all stakeholders[3].

Conclusion

The market dynamics and financial trajectory of BSS PLUS are significantly influenced by emerging cost-plus drug pricing models. These models offer transparency, affordability, and potential cost savings, which can be attractive to both consumers and payers. However, they also present challenges, such as the need for payer support and the integration of insurance benefits.

Key Takeaways

• Pricing Transparency: Cost-plus models simplify and reduce drug costs by charging a flat markup over the cost of the drug.
• Consumer Savings: These models can lead to substantial savings for consumers, as seen in pilot programs.
• Payer Perspectives: Payers are divided but prioritize cost savings and drug availability.
• Financial Trajectory: Revenue per unit may decrease, but volume sales could increase due to affordability.
• Regulatory and Competitive Landscape: Regulatory pressure and competitive strategies are driving the adoption of transparent pricing models.
• Value-Based Pricing: Economic and cost aspects, as well as patient and societal benefits, must be considered in pricing BSS PLUS.

FAQs

Q: How do cost-plus drug pricing models work?

A: Cost-plus models charge a flat markup over the cost of the drug, plus pharmacy fees, eliminating excessive markups and providing transparent pricing.

Q: Why are payers divided on working with cost-plus models?

A: Payers are concerned about the business model's non-inclusion of most insurance benefits and the potential for confusion among patients regarding their drug costs.

Q: What are the key factors for payers considering cost-plus models?

A: Payers consider member cost and drug availability as very important factors when deciding to partner with cost-plus models.

Q: How could the adoption of cost-plus models impact the revenue of BSS PLUS?

A: The revenue per unit sold may decrease due to lower pricing, but this could be offset by increased volume sales due to the drug's newfound affordability.

Q: What role do regulatory bodies play in the adoption of cost-plus models?

A: Regulatory bodies are pressuring PBMs to deliver more transparent pricing and lower costs, driving the adoption of cost-plus models by major retailers.

Sources

1. MMIT Network: "Why Payers Are Split on Working With Mark Cuban's Cost Plus Drug Company"
2. Santen Pharmaceutical: "Annual Report 2018"
3. Frontiers in Pharmacology: "Unraveling elements of value-based pricing from a pharmaceutical industry’s perspective"
4. American Hospital Association: "Cost-Plus Drug Pricing Models Gain Momentum, but Will They Last?"