FLO-PRED Drug Patent Profile

Which patents cover Flo-pred, and when can generic versions of Flo-pred launch?

Flo-pred is a drug marketed by Taro and is included in one NDA. There is one patent protecting this drug.

This drug has eleven patent family members in nine countries.

The generic ingredient in FLO-PRED is prednisolone acetate. There are eighty-eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flo-pred

A generic version of FLO-PRED was approved as prednisolone acetate by LUPIN LTD on August 2^nd, 2024.

Summary for FLO-PRED

International Patents:	11
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	74
Patent Applications:	3,854
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FLO-PRED
What excipients (inactive ingredients) are in FLO-PRED?	FLO-PRED excipients list
DailyMed Link:	FLO-PRED at DailyMed

US Patents and Regulatory Information for FLO-PRED

FLO-PRED is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-001	Jan 17, 2008		DISCN	No	No	7,799,331		Y
Taro	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-002	Jan 17, 2008		DISCN	No	No	7,799,331		Y

Expired US Patents for FLO-PRED

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Taro	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-001	Jan 17, 2008	6,102,254
Taro	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-002	Jan 17, 2008	6,656,482
Taro	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-001	Jan 17, 2008	6,399,079
Taro	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-001	Jan 17, 2008	5,881,926

International Patents for FLO-PRED

See the table below for patents covering FLO-PRED around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	4326199
Australia	2006278620	Oral suspension of prednisolone acetate
Austria	312598
Israel	108366

Market Dynamics and Financial Trajectory for Flo-Pred (Prednisolone Acetate)

Introduction

Flo-Pred, a prednisolone acetate oral suspension, was approved by the FDA on January 17, 2008, for the treatment of various inflammatory and allergic conditions, including asthma and dermatologic conditions. Here, we will delve into the market dynamics and financial trajectory of this drug.

FDA Approval and Initial Market Entry

Flo-Pred was introduced to the market by Taro Pharmaceuticals USA, Inc., as a cherry-flavored oral liquid corticosteroid that does not require refrigeration or shaking before use. This convenience factor was a significant selling point, especially for pediatric and geriatric patients[1].

Market Positioning

Upon its approval, Flo-Pred entered a competitive market for corticosteroids. Its unique formulation and ease of use helped it gain traction among healthcare providers and patients. However, the market for corticosteroids is highly competitive, with numerous generic and branded options available.

Dosage and Treatment Indications

The dosage of Flo-Pred varies widely depending on the disease being treated, ranging from 5 mg to 60 mg per day. The need for individualized dosing based on patient response and disease severity adds complexity to its market positioning but also highlights its versatility[5].

Financial Performance

Although specific financial data for Flo-Pred is not readily available, the drug's approval and market entry were significant events for Taro Pharmaceuticals. The company likely invested substantial resources in research, development, and marketing to bring this product to market.

Market Trends in Pharmaceuticals

The pharmaceutical market, particularly for corticosteroids, is influenced by several trends:

• Generic Competition: The rise of generic drugs has put pressure on branded medications, including Flo-Pred. Generic versions of prednisolone acetate are available, which can impact the market share of branded products[3].
• Rebates and Discounts: The pharmaceutical industry is characterized by a "gross-to-net bubble," where list prices are high but net prices are lower due to rebates and discounts. This can affect the revenue generated by Flo-Pred[3].

Regulatory Environment

The regulatory landscape for pharmaceuticals is stringent and evolving. States and federal agencies play a crucial role in monitoring and regulating drugs, including those like Flo-Pred. Changes in regulatory policies can impact the drug's market dynamics and financial performance.

Discontinuation and Market Impact

Flo-Pred is currently discontinued, which significantly affects its financial trajectory. The discontinuation could be due to various factors such as market competition, regulatory issues, or strategic decisions by Taro Pharmaceuticals. This move would have led to a cessation of sales and revenue generation from this product.

Alternative Treatments and Market Shifts

The discontinuation of Flo-Pred has likely led patients and healthcare providers to seek alternative treatments. This shift can benefit other corticosteroid products in the market, both branded and generic. The market share that Flo-Pred once held would be redistributed among these alternatives.

Consumer and Healthcare Provider Preferences

Consumer and healthcare provider preferences play a crucial role in the market dynamics of pharmaceuticals. The ease of use and convenience of Flo-Pred were key selling points, but these advantages are now lost with its discontinuation. Other products that offer similar or better convenience and efficacy are likely to gain preference.

Impact on Taro Pharmaceuticals

The discontinuation of Flo-Pred would have financial implications for Taro Pharmaceuticals. The company would need to adjust its product portfolio and focus on other revenue-generating products. This could involve investing in new research and development or acquiring new products to fill the gap left by Flo-Pred.

Conclusion on Market Dynamics

The market dynamics for Flo-Pred have been significantly altered by its discontinuation. While it once held a niche in the market for its convenience and efficacy, its absence has created opportunities for other corticosteroid products. The financial trajectory of Flo-Pred is now a historical footnote, with any remaining impact limited to the transition period as patients and providers adjust to alternative treatments.

Key Takeaways

• FDA Approval and Market Entry: Flo-Pred was approved in 2008 as a convenient oral corticosteroid.
• Dosage and Treatment: The drug required individualized dosing based on disease severity.
• Financial Performance: Specific financial data is not available, but the drug's discontinuation has ended its revenue generation.
• Market Trends: Generic competition, rebates, and regulatory changes impact the pharmaceutical market.
• Discontinuation: Flo-Pred is no longer available, leading to a shift in market share to alternative treatments.
• Impact on Taro Pharmaceuticals: The company must adjust its product portfolio and focus on other revenue-generating products.

FAQs

What was Flo-Pred used for?

Flo-Pred was used for the treatment of asthma, certain allergic and dermatologic conditions, and other inflammatory indications.

Who manufactured Flo-Pred?

Flo-Pred was manufactured by Taro Pharmaceuticals USA, Inc.

Why is Flo-Pred no longer available?

Flo-Pred is currently discontinued, although the specific reasons for this are not detailed in available sources.

How did the discontinuation of Flo-Pred affect the market?

The discontinuation led to a shift in market share to other corticosteroid products, both branded and generic.

What are the implications for Taro Pharmaceuticals?

Taro Pharmaceuticals must adjust its product portfolio and focus on other revenue-generating products to compensate for the loss of Flo-Pred.

Cited Sources

1. Drugs.com: Flo-Pred (prednisolone acetate) FDA Approval History.
2. PR Newswire: Flo Health Secures More than $200M Investment from General Atlantic.
3. Drug Channels Institute: The 2024 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers.
4. Georgia Department of Community Health: March 26, 2015 - DURB Handout.
5. FDA: Flo-Pred (prednisolone acetate oral suspension) - Label.