Emedastine Difumarate Patent Expiration

Emedastine Difumarate is Used for treating allergic conjunctivitis. It was first introduced by Novartis Pharmaceuticals Corp in its drug Emadine on Dec 29, 1997.


Emedastine Difumarate Patents

Given below is the list of patents protecting Emedastine Difumarate, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Emadine US5441958 Ophthalmic compositions comprising emedastine and methods for their use Dec 08, 2013

(Expired)

Novartis



Emedastine Difumarate's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Emedastine Difumarate:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
This Phase 1a Study Will Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Relative Bioavailability of Single-dose DMI019 Nasal Spray in Healthy Participants. The Third Xiangya Hospital of Central South University NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1


Emedastine Difumarate Generic API Manufacturers

Given below is the list of companies who have filed for Emedastine Difumarate generic, along with the locations of their manufacturing plants worldwide.