ALREX Drug Patent Profile

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

Alrex is a drug marketed by Bausch And Lomb and is included in one NDA.

The generic ingredient in ALREX is loteprednol etabonate. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alrex

A generic version of ALREX was approved as loteprednol etabonate by SENTISS on April 17^th, 2019.

Summary for ALREX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	63
Patent Applications:	4,594
Drug Prices:	Drug price information for ALREX
Drug Sales Revenues:	Drug sales revenues for ALREX
What excipients (inactive ingredients) are in ALREX?	ALREX excipients list
DailyMed Link:	ALREX at DailyMed

See drug prices for ALREX

See drug sales revenues for ALREX

Pharmacology for ALREX

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for ALREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	ALREX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020803-001	Mar 9, 1998	AB	RX	Yes	Yes

Expired US Patents for ALREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	ALREX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020803-001	Mar 9, 1998
Bausch And Lomb	ALREX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020803-001	Mar 9, 1998
Bausch And Lomb	ALREX	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	020803-001	Mar 9, 1998

International Patents for ALREX

See the table below for patents covering ALREX around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1174667	STEROIDES DOUX AYANT DES PROPRIETES ANTI- INFLAMMATOIRES (SOFT STEROIDS HAVING ANTI-INFLAMATORY ACTIVITY)
Spain	8306767
Sweden	449106	STEROID MED ANTI-INFLAMMATORISK VERKAN SAMT KOMPOSITION INNEHALLANDE DENNA

Market Dynamics and Financial Trajectory for Alrex (Loteprednol Etabonate Ophthalmic Suspension)

Introduction to Alrex

Alrex, also known as Loteprednol Etabonate Ophthalmic Suspension, is a prescription medication used for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. It is a corticosteroid eye drop formulated to reduce inflammation and itching associated with allergic reactions in the eyes.

Market Value and Demand

As of October 2023, the market value of Loteprednol Etabonate Ophthalmic Suspension 0.2% (the generic equivalent of Alrex) was approximately $29.1 million, according to IQVIA data[1].

Generic Competition

The entry of generic versions of Alrex into the market can significantly impact its financial trajectory. Recently, Lupin received FDA approval for its generic version of Loteprednol Etabonate Ophthalmic Suspension 0.2%, which is expected to increase competition and potentially reduce the market share of the branded version[1].

Indications and Usage

Alrex is specifically indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. This targeted indication means that the drug's market is limited to patients suffering from this specific condition, which can affect its overall market size and growth potential.

Competitive Landscape

The ophthalmic corticosteroid market is competitive, with several other products available for similar indications. Bausch & Lomb, the original manufacturer of Alrex, faces competition not only from generics but also from other branded and generic corticosteroid eye drops. This competition can lead to pricing pressures and reduced market share for Alrex.

Financial Impact of Generic Entry

The introduction of generic versions typically leads to a significant reduction in the sales of the branded product. Generic drugs are often priced lower, making them more attractive to patients and healthcare providers. This shift can result in a substantial decline in revenue for the branded version of Alrex.

Manufacturing and Distribution

The generic version of Alrex by Lupin will be manufactured at their Pithampur facility in India. This global supply chain can help in reducing costs and increasing the availability of the generic drug, further impacting the market dynamics of Alrex[1].

Patient and Prescriber Behavior

Patient and prescriber preferences play a crucial role in the market dynamics of pharmaceuticals. With the availability of generic alternatives, prescribers may increasingly opt for the generic version due to cost considerations, which can further erode the market share of the branded Alrex.

Regulatory Environment

Regulatory approvals and changes in healthcare policies can also influence the market trajectory of Alrex. For instance, any changes in reimbursement policies or formulary listings can affect the drug's accessibility and affordability, impacting its sales.

Historical Performance of Bausch & Lomb

Bausch & Lomb, as part of Valeant Pharmaceuticals (now Bausch Health), has experienced various market and financial challenges. The company has undergone significant restructuring and divestitures to stabilize its business and focus on core areas of growth. The performance of Alrex would be part of this broader corporate strategy[3].

Future Outlook

Given the competitive landscape and the entry of generic versions, the future outlook for Alrex is likely to be challenging. Here are some key points to consider:

• Revenue Decline: The introduction of generic versions is expected to lead to a decline in revenue for the branded Alrex.
• Market Share: The market share of Alrex is likely to decrease as generic alternatives gain traction.
• Pricing Pressure: Increased competition will likely result in pricing pressures, further reducing the revenue potential of Alrex.
• Patient Access: While generics may increase patient access to the medication due to lower costs, this also means reduced revenue for the branded product.

Key Takeaways

• Market Value: The market value of Loteprednol Etabonate Ophthalmic Suspension 0.2% was approximately $29.1 million as of October 2023.
• Generic Competition: The entry of generic versions will increase competition and reduce the market share of the branded Alrex.
• Financial Impact: The introduction of generics is expected to lead to a significant decline in revenue for the branded version.
• Regulatory and Market Factors: Changes in regulatory policies and patient/prescriber behavior will continue to influence the market dynamics of Alrex.

FAQs

Q: What is Alrex used for? A: Alrex (Loteprednol Etabonate Ophthalmic Suspension) is used for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

Q: How does the entry of generic versions affect Alrex? A: The entry of generic versions is expected to increase competition, reduce the market share of the branded Alrex, and lead to a decline in revenue due to pricing pressures.

Q: Who manufactures the generic version of Alrex? A: Lupin has received FDA approval for its generic version of Loteprednol Etabonate Ophthalmic Suspension 0.2%, which will be manufactured at their Pithampur facility in India.

Q: What is the current market value of Loteprednol Etabonate Ophthalmic Suspension 0.2%? A: As of October 2023, the market value was approximately $29.1 million, according to IQVIA data.

Q: How does the competitive landscape affect Alrex? A: The ophthalmic corticosteroid market is competitive, with several other products available for similar indications, leading to pricing pressures and reduced market share for Alrex.

Sources

1. Drug Store News: Lupin receives FDA nod for 3 generics.
2. Ardelyx: Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update.
3. Valeant Pharmaceuticals International, Inc.: 2016 Annual Report.
4. Aldeyra Therapeutics: FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease.
5. Ardelyx: Reports Second Quarter 2024 Financial Results and Provides Business Update.