EMADINE Drug Patent Profile

Which patents cover Emadine, and what generic alternatives are available?

Emadine is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in EMADINE is emedastine difumarate. There is one drug master file entry for this compound. Additional details are available on the emedastine difumarate profile page.

Summary for EMADINE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	58
Patent Applications:	2,076
Drug Prices:	Drug price information for EMADINE
DailyMed Link:	EMADINE at DailyMed

See drug prices for EMADINE

US Patents and Regulatory Information for EMADINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	EMADINE	emedastine difumarate	SOLUTION/DROPS;OPHTHALMIC	020706-001	Dec 29, 1997		DISCN	Yes	No

Expired US Patents for EMADINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EMADINE	emedastine difumarate	SOLUTION/DROPS;OPHTHALMIC	020706-001	Dec 29, 1997
Novartis	EMADINE	emedastine difumarate	SOLUTION/DROPS;OPHTHALMIC	020706-001	Dec 29, 1997

International Patents for EMADINE

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0673250	COMPOSITIONS OCULAIRES COMPORTANT DE L'EMEDASTINE ET UTILISATION DESDITES COMPOSITIONS POUR TRAITER LA CONJONCTIVITE ALLERGIQUE (OPHTHALMIC COMPOSITIONS COMPRISING EMEDASTINE AND THEIR USE FOR TREATING ALLERGIC CONJUNCTIVITIS)
Denmark	0673250
Japan	H06172179	ANTIALLERGIC EYE DROP
Greece	3032264
Japan	H0224821
Austria	19878
Austria	185696

EMADINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EMADINE

Introduction

EMADINE, the brand name for emedastine ophthalmic solution, is a medication approved by the FDA for the treatment of allergic conjunctivitis. Here, we will delve into the market dynamics and financial trajectory of EMADINE, including its current status, historical context, and future prospects.

Approval and Historical Context

EMADINE was approved by the FDA on December 29, 1997, in the formulation of emedastine difumarate 0.05% ophthalmic solution. It was manufactured by Novartis[1].

Current Market Status

Discontinuation of Formulations

All formulations of EMADINE have been discontinued. This means that the drug is no longer actively produced or marketed by its original manufacturer, Novartis. The discontinuation can significantly impact the drug's availability and pricing in the market[1].

Safety and Efficacy

Clinical Trials and Adverse Effects

In clinical trials involving 696 patients, approximately 7% of patients experienced adverse drug reactions associated with EMADINE, although less than 1% discontinued therapy due to these reactions. The drug has shown concentration-dependent inhibition of histamine-stimulated conjunctival vascular permeability, which is crucial for its therapeutic effect[4].

Regulatory Considerations

FDA Approval and Generic Availability

Despite its approval, EMADINE does not have a generic version available in the market. The FDA has not approved any generic versions, and any attempts to sell generic EMADINE online should be treated with caution due to the risk of counterfeit medications[1].

Financial Trajectory

Historical Revenue

Since EMADINE's formulations have been discontinued, there is no current revenue stream from this drug. Historically, the revenue would have been part of Novartis's ophthalmic product portfolio, but specific financial data for EMADINE alone is not readily available.

Market Impact of Discontinuation

Patient Access and Alternatives

The discontinuation of EMADINE formulations affects patient access to this specific treatment for allergic conjunctivitis. Patients may need to switch to alternative medications, which could be more expensive or have different side effect profiles. This shift can influence the overall market dynamics for ophthalmic medications.

Competitive Landscape

Alternative Treatments

The ophthalmic market for allergic conjunctivitis treatments is competitive, with several other medications available. The absence of EMADINE from the market allows other brands to capture the market share, potentially increasing their revenue and market presence.

Future Prospects

Potential for Revival or Generic Entry

Although the original formulations of EMADINE have been discontinued, there is always a possibility that another pharmaceutical company could revive the drug or develop a generic version. However, this would require new FDA approvals and significant investment in manufacturing and marketing.

Global Pharmaceutical Market Trends

Impact on Rare and Niche Markets

Companies like Immedica, which focus on rare diseases and niche markets, often face similar challenges with drug availability and regulatory approvals. The success of such companies in navigating these complexities can provide insights into how drugs like EMADINE might be managed in the future[2].

Telemedicine and Online Pharmacies

Access to Medications

The increasing use of telemedicine and online pharmacies can improve access to medications, including those for rare conditions. However, this trend does not directly impact EMADINE since it is no longer in production[3].

Key Takeaways

• Discontinuation: All EMADINE formulations have been discontinued, affecting patient access and market dynamics.
• Regulatory: No generic versions are approved, and caution is advised against counterfeit medications.
• Financial: No current revenue stream due to discontinuation.
• Market Impact: Patients must switch to alternative treatments, influencing the competitive landscape.
• Future Prospects: Potential for revival or generic entry, but requires new FDA approvals and significant investment.

FAQs

What is EMADINE used for?

EMADINE is used for the treatment of allergic conjunctivitis.

Why has EMADINE been discontinued?

All formulations of EMADINE have been discontinued by the manufacturer, Novartis, although the specific reasons are not detailed.

Are there any generic versions of EMADINE available?

No, there are no FDA-approved generic versions of EMADINE available in the market.

What are the potential side effects of EMADINE?

Approximately 7% of patients experienced adverse drug reactions in clinical trials, with less than 1% discontinuing therapy due to these reactions.

Can EMADINE be purchased online?

Purchasing EMADINE online is not recommended due to the risk of counterfeit medications. It is advisable to consult a healthcare provider for legitimate sources.

Sources

1. Drugs.com: Generic Emadine Availability.
2. Cision: Preparing for launch - Immedica.
3. Future Market Insights: Compounded Topical Drugs Market Sees Significant Growth.
4. European Medicines Agency: Emadine, INN-emedastine - European Medicines Agency.