Emadine is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 08, 2013. Details of Emadine's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5441958 | Ophthalmic compositions comprising emedastine and methods for their use |
Dec, 2013
(12 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but
Emadine is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Emadine's family patents as well as insights into
ongoing legal events
on those patents.
Emadine's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Emadine:
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 |
|---|---|---|---|---|
 | ||||
| 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 |
Generic Launch
Generic Release Date:
Emadine's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 08, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Emadine Generics:
There are no approved generic versions for Emadine as of now.
About Emadine
Emadine is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating allergic conjunctivitis. Emadine uses Emedastine Difumarate as an active ingredient. Emadine was launched by Novartis in 1997.
Approval Date:
Emadine was approved by FDA for market use on 29 December, 1997.
Active Ingredient:
Emadine uses Emedastine Difumarate as the active ingredient. Check out other Drugs and Companies using Emedastine Difumarate ingredient
Treatment:
Emadine is used for treating allergic conjunctivitis.
Dosage:
Emadine is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.05% | SOLUTION/DROPS | Discontinued | OPHTHALMIC |