X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
Details:
Mydcombi is Eyenovia's USFDA approved, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic mydriasis (eye dilation).
Lead Product(s): Phenylephrine Hydrochloride,Tropicamide
Therapeutic Area: Ophthalmology Product Name: Mydcombi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 08, 2023
Details:
Under the terms of the Agreement, the royalty rate applicable to U.S. net sales of OMIDRIA (phenylephrine) decreased from 50 percent to 30 percent of U.S. net sales following achievement of the Milestone Event.
Lead Product(s): Phenylephrine Hydrochloride,Ketorolac Trometamol
Therapeutic Area: Ophthalmology Product Name: Omidria
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Rayner
Deal Size: $1,326 million Upfront Cash: $126.0 million
Deal Type: Divestment February 06, 2023
Details:
Mydcombi is Eyenovia's investigational, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic mydriasis (eye dilation).
Lead Product(s): Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Mydcombi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 12, 2023
Details:
Mydcombi is Eyenovia's investigational, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic mydriasis (eye dilation).
Lead Product(s): Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Mydcombi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2022
Details:
The financing is intended to support manufacturing in anticipation of a MydCombi (tropicamide) launch and clinical supply for ongoing programs. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis and myopia progression.
Lead Product(s): Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: Mydcombi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Avenue Venture Opportunities Fund
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing November 29, 2022
Details:
Under the Royalty Purchase Agreement, DRI is entitled to royalties on net sales of OMIDRIA (having phenylephrine) received between September 1, 2022 and December 31, 2030, subject to annual caps.
Lead Product(s): Phenylephrine Hydrochloride,Ketorolac Trometamol
Therapeutic Area: Neurology Product Name: Omidria
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: DRI Healthcare Acquisitions
Deal Size: $188.4 million Upfront Cash: Undisclosed
Deal Type: Agreement October 03, 2022
Details:
Under terms of the agreement, Dr Reddy’s purchased the Biorphen® (phenylephrine hydrochloride), Rezipres®, and Cysteine Hydrochloride products. Dr Reddy’s will immediately take ownership of Eton’s rights and interests in the products.
Lead Product(s): Phenylephrine Hydrochloride
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Biorphen
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Dr. Reddy\'s Laboratories
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition June 24, 2022
Details:
MydCombi™ has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery.
Lead Product(s): Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: MydCombi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2022
Details:
As part of the agreement, Rayner will acquire the OMIDRIA (phenylephrine) commercial organization, including the OMIDRIA sales force. In addition, Rayner plans to expand the sales force in both the U.S. and ex-U.S.
Lead Product(s): Phenylephrine Hydrochloride,Ketorolac Trometamol
Therapeutic Area: Ophthalmology Product Name: Omidria
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Rayner
Deal Size: $1,326 million Upfront Cash: $126.0 million
Deal Type: Divestment December 23, 2021
Details:
As part of the agreement, Rayner will acquire the OMIDRIA commercial organization, including the OMIDRIA sales force. Rayner plans to expand the sales force in both the U.S. and ex-U.S., and further accelerating U.S. market growth of OMIDRIA.
Lead Product(s): Phenylephrine Hydrochloride,Ketorolac Trometamol
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: Omidria
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Rayner Surgical Group Limited
Deal Size: $1,000.0 million Upfront Cash: $125.0 million
Deal Type: Agreement December 02, 2021
Details:
As part of the agreement, Rayner will acquire the OMIDRIA (phenylephrine) commercial organization, including the OMIDRIA sales force. In addition, Rayner plans to expand the sales force in both the U.S. and ex-U.S.
Lead Product(s): Phenylephrine Hydrochloride,Ketorolac Trometamol
Therapeutic Area: Ophthalmology Product Name: Omidria
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Rayner
Deal Size: $1,325 million Upfront Cash: $125.0 million
Deal Type: Divestment December 02, 2021
Details:
The NDA submission follows the initial enrollment of the VISION-1 study, Eyenovia’s Phase 3 study for MicroLine in presbyopia, with top-line data expected the first half of 2021.
Lead Product(s): Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area: Ophthalmology Product Name: MydCombi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 29, 2020
Details:
This diverse portfolio of products includes Breathe Right® Nasal Strips, the world’s #1 nasal strip, and Children’s Dimetapp®, the #1 pharmacist-recommended brand for children's cough and cold products, as well as Anbesol®, Alavert®, Dristan®, Primatene Tablets® and FiberCon®.
Lead Product(s): Brompheniramine Maleate,Dextromethorphan Hydrobromide,Phenylephrine Hydrochloride
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Dimetapp
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Foundation Consumer Healthcare
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 16, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
