Royalty Report: Drugs, Pharmaceuticals, Therapeutic – Collection: 6891

$100.00

Curated Royalty Rate Report
Created On: 2020-07-15, Record Count: 4

Description

This collection of transactions and supporting information was developed using our AI algorithm to curate similar royalty reports into a cohesive collection to support your licensing, transfer pricing or other transaction scenarios where documented royalty rates and/or deal terms are important.
Created On: 2020-07-15
Record Count: 4

Primary Industries

  • Drugs
  • Pharmaceuticals
  • Therapeutic
  • Disease
  • Delivery

IPSCIO Report Record List

Below you will find the records curated into this collection.  This summary includes the complete licensed property description so that you can review and determine if this collection covers the topics, technology or transaction type that is relevant for your needs.  The full report will include all relevant deal data such as the royalty base, agreement date, term description, royalty rates and other deal terms.  For reference, here is a sample of a full IPSCIO curated royalty rate report: Sample Report

IPSCIO Record ID: 6891

License Grant
The Company transferred all of the North American intellectual property relating to the Orapred product.

The Licensor receives royalty revenues on Orapred products, a product acquired in 2004 and subLicensed in 2006.

License Property
Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) is a prescription drug product indicated for the control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with asthma or asthma caused by respiratory disorders.
Field of Use
The rights granted apply to the medical industry.

IPSCIO Record ID: 5768

License Grant
Licensor hereby grants to Licensee an exclusive, non-transferable royalty-bearing sublicense to and under the Licensed Assets to develop, make, have made, use, market, offer for sale, sell, distribute, and import the Licensed Products solely during the License Term in North America (the Sublicense).
License Property
Orapred ODT is prescribed primarily for acute exacerbations of asthma in children.  This will be the first orally disintegrating tablet form of prednisolone available in the United States.  The FDA recently granted marketing approval.

The Orapred product line is also used to control severe, persistent asthma and to reduce inflammation seen in numerous medical conditions including arthritis and cancer.  Orapred ODT utilizes a proprietary orally disintegrating tablet technology to provide a taste-masked, non-refrigerated and convenient formulation of prednisolone.  Licensor retains rights outside North America.

New Drug Applications

Abbreviated New Drug Applications

Orapred (Prednisolone Sodium Phosphate Oral Solution), 20.2 mg/ 5 ML, (equivalent to 15 mg (base)/ 5 ML) – ANDA 75-117

Orapred RT (Prednisolone Sodium Phosphate Oral Solution), 20.2 mg/ 5 ML, (equivalent to 15 mg (base)/ 5 ML) – ANDA 77-485

505(B)(2) New Drug Application

Orapred ODT (Prednisolone Sodium Phosphate

Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg Prednisolone base) – NDA 21-959

Development Licensed Patents

Patent/Application Number

OraSolv® Technology

US 5178878 A

US 08/468,913

CA 2,061,917

PakSolv® Technology

US 6,155,423

CA 2284132

US 6,269,615

US 6,311,462

DuraSolv® Technology

US 6,024,981

US 6,221,392

CA 2284663

Licensed Trademarks

Orapred

Orapred ODT

CIMA

CIMA LABS INC.

OraSolv®

PakSolv®

DuraSolv®

CIMA, CIMA LABS INC. OraSolv®, PakSolv®, DuraSolv®, and are Cima Trademarks.

Taste Masking Related Licensed Patents

Patent/Application Number

Pleasant Tasting Aqueous Liquid Composition of a Bitter-Tasting Drug

Anaebonam, Aloysius O.

Clemente, Emmett

Fawzy, Abdel A.

08/692,081

5763449

United States

09/011,156

5962461

United States

2260852

2260852

Canada

991273

Mexico

Room Temperature Stable Aqueous Liquid Pharmaceutical Composition

Emmett Clemente, Bhiku Patel, Kuljit Bhatia, Frank L. Sorgi, and Emil D. Kakkis

Medicis Pharmaceutical Corporation, Ascent Pediatrics Inc., BioMarin Pharmaceutical Inc.

11/066,113

United States

PCT/US2005/006576

Transferred Inventory of Orapred

Description

8 oz. Trade bottles

  
Lot Numbers
  
Expiration Date
  
Units
  
NDC Number

  
RM0421
  
39416
  
24204
  
68135-455-02

RM0501

39447

12108

Institutional packs

RM0502

39447

12192

RM0504

39478

10740

8 oz. Samples

  
RM0502A
  
39447
  
12960
  
68135-455-03

6 pack, 20 ml samples

  
RM0505
  
39538
  
10656
  
68135-455-04

8 oz. Authorized generic bottles
  
RM0504A
  
39538
  
13315
  
68135-455-01

RM0505A

22408

  
05PSP05
  
39568
  
24144
  
NA

05PSP06

39568

24288

05PSP07

39599

24348

Field of Use
A North American license and acquisition agreement signed  in March 2006 granted rights to a privately held pediatric specialty pharmaceutical company covering Orapred ODT (prednisolone sodium phosphateorally disintegrating tablets).

IPSCIO Record ID: 28457

License Grant
The Company acquired an exclusive North American license to certain patent rights and other intellectual property relating to Altolyn, an oral formulation product candidate using sodium cromoglicate for the treatment of mastocytosis, food allergies, and inflammatory bowel disorder.
License Property
Altolyn is a proprietary site specific tablet formulation of oral cromolyn sodium for the treatment of mastocytosis.

Mastocytosis is a group of rare disorders of both children and adults caused by the presence of too many mast cells (mastocytes) and CD34+ mast cell precursors in a person's body.  You can find mast cells in skin, lymph nodes, internal organs (such as the liver and spleen) and the linings of the lung, stomach, and intestine. Mast cells play an important role in helping your immune system defend these tissues from disease. Mast cells attract other key players of the immune defense system to areas of your body where they are needed by releasing chemical alarms such as histamine and cytokines.

IPSCIO Record ID: 7576

License Grant
Canadian Licensor hereby grants to the Canadian Licensee, an exclusive worldwide, perpetual license under the Patents and the Licensed Know-How, with such exclusivity being limited to the right to and for the sole purpose the Licensed Application ('License').  The Oral Dissolving Technology is exclusively available to the Canadian Licensee through the License Agreement.
License Property
'Product' shall mean Sildenafil Citrate.

An orally disintegrating tablet or orodispersible tablet (ODT) is a drug dosage form available for a limited range of over-the-counter and prescription medications. ODTs differ from traditional tablets in that they are designed to be dissolved on the tongue rather than swallowed whole.

'Licensed Patents' shall mean Intellectual Property solely relating to the Product and US Patent Application 2007/01.90144 (Novel formulation for sublingual drug delivery and use thereof) and all corresponding know-how, patents, patent applications, continuation applications, continuation, etc.

Field of Use
'Field of Use' shall mean oral dissolving technology (sublingual) delivery of the Product.

The first product the Licensee will develop with this technology is sublingual sildenafil. This therapy is used for erectile disfuction.

The Licensee is to complete the required studies and regulatory tasks to commercialize products using the oral dissolving technology and is responsible for any all clinical trials related to the development of products using ODT technology.

Disclaimer: The information gathered from RoyaltySource® database was sourced from the U.S. Securities and Exchange Commission EDGAR Filings and other public records. While we believe the sources to be reliable, this does not guarantee the accuracy or completeness of the information provided. Further, the information is supplied as general guidance and is not intended to represent or be a substitute for a detailed analysis or professional judgment. This information is for private use only and may not be resold or reproduced without permission.