Examples of information found in this online report include:
General Information
'General Information' contains a summary of dosage forms, strengths, indications and active ingredient forms of the brand product in major countries*.
- Indicates the required attributes of a generic equivalent.
- A reference for determining the relevance of identified patents.
- Marketing authorisation holders in key territories
Data Exclusivity
First to market authorisation data enables you to calculate data exclusivity in key territories (Europe, US, Canada and Australia). Expanded US exclusivity types (for example New Combinations, Use etc.) are also shown along with NCE data exclusivity.
Marketing Authorisation Holders
Marketing authorisation holders for Great Britain, the United States, Canada and Australia enable you to see who is active in the market.
US Drug Master Files
DMF records submitted to the FDA provide valuable information to help source active ingredients and keep an eye on competitors.
Paragraph IV filings
Details of US ANDAs filed with a Paragraph IV certification allow easy determination of who the first movers are for a particular generic product in the US.
Key Patent Indicator
The
'Key Patent Indicator' enables identification of key patents, their coverage, and estimated expiry dates in significant countries**.
- Based on US FDA Orange Book analysis and additional sources.
- Click-through to patent documents (1) and national registers (2).
- Foreign equivalents in key generics markets (US, Great Britain, Germany, Canada and Australia (3)) identified, including expiry dates (4) and extensions.
- Legal status and patent documents (5) for 65 additional territories.
Patent Risk Analysis
The 'Patent Risk Analysis' section contains three graphical displays of data drawn from known patent filings to provide valuable competitor insight and development information.
- (6) Identifies which areas of the generic (molecule, process, formulation or use) are heavily patented, and thus indicates which areas will be problematic.
- (7) Identifies the most significant companies actively conducting research and development on this drug.
- (8) Maps the types of patents filed over time. Provides an indication of how effectively the generic has been protected.
Pipeline Development
After using a Pipeline™ Selector report to determine whether a drug is suitable for development, you can upgrade to a Pipeline™ Developer report to gain access to comprehensive patent information based on a professional patent search, with regular updating.
*General Drug Information
Information contained in
'General Indications' and
'Brand Product Attributes' is based on products containing the active pharmaceutical ingredient, which are currently registered in Australia, UK and the USA. Indications are summarised where appropriate and may vary between individual countries.
**Key Patent Indicator
The
'Key Patent Indicator' section is intended only to provide an indication of the key patents pertaining to a generic drug, and is not based on a comprehensive patent search (a comprehensive patent search can be found in the corresponding Pipeline™ Developer report). The 'Key Patent Indicator' information is primarily based on the US FDA Orange Book, thus the following limitations must be recognised:
1) Only patent interests of the innovator are listed.
2) Claims of US patents may be substantially different from those in other countries.
3) Not all patents have US equivalents, therefore key patents may exist in other countries that are not identifiable via the Orange Book method.
4) Process patents are not listed in the US FDA Orange Book.
***Patent Risk Analysis
The three graphical analyses are based on data contained in our Pipeline™ Developer comprehensive patent search, and thus are subject to its scope and limitations. These graphics are intended to provide only a summary of the patent filings; specific details of the filings should be investigated through the use of the Pipeline™ Developer reports.
