Imiquimod: Core Country Coverage

Indications: Anogenital warts; Superficial basal cell carcinoma
Innovator: 3M (Aldara)

Pipeline Selector: single-drug access to essential competitor, regulatory and patent expiry information for quick and easy selection of your generics pipeline.

Pipeline Selector is provided on a per drug basis and is now available in two access levels; 'core', covering 7 key countries, and 'extended', covering 37 ; you are currently viewing information on the extended version.

Pipeline Selector makes single drug development decisions easy, by quickly providing you with an accurate snapshot of a single INN, including key patents, regulatory issues and players. Offering key patent, SPC and data protection expiry information covering 37 countries, Pipeline Selector gives you exactly the data you need when you need it, with no commitment to an entire database of unnecessary information.

Pipeline Selector is an online intelligence tool provided on a per drug basis:

• Includes key patent publications for 7 countries
• Contains SPC protection for every EU state plus patent term extensions in other countries
• Data exclusivity calculated on a country by country basis
• Summary of dosage forms, strengths, indications and active ingredient forms of the brand product
• DMF & Paragraph IV filings
• Litigation alerts
• Marketing authorisation holders in selected territories
• Patent risk analysis via graphical display of data from patent filings
• Hyper-linking to crucial patent documents and national registries enabling data verification

Examples of information found in this online report include:

Key Patent Indicator

The 'Key Patent Indicator' enables identification of key patent, SPC and data protection expiry information covering 7 territories*:

Pipeline Selector Extended Country Coverage

Other key information contained in Pipeline Selector

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
• News articles

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.

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***.

• Patent Category Distribution identifies which areas of the generic (molecule, process, formulation or use) are heavily patented, and thus indicates which areas will be problematic.
• Top Patent Applicants Identifies the most significant companies actively conducting research and development on this drug.
• Patent Filing Trends 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.

*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). A Key Patent Family is identified as being relevant to an INN if it is:

1. US Orange Book Listed for that INN
2. Canadian Patent Register Listed
3. Nominated for Extension in any territory covered in Selector Extended
4. Manually identified as being a key constraint by GenericsWeb Analysts

**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.

***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.