Exclusivity

Types of Marketing Exclusivity

There are various types of marketing exclusivity which have a different duration. For getting the market exclusivity the applicant must meet certain requirements.

Some of the major exclusivities are as under:

• Paediatric Exclusivity (PED): Exclusivity duration is of 180 days. It can be added to any existing exclusivity.
• Generic Drug Exclusivity (GDE): Exclusivity duration is of 180 days
• Clinical Investigation Exclusivity (CIE): Exclusivity duration is of 3 yrs
• New Chemical Entity (NCE) Exclusivity: Exclusivity duration is of 5 yrs
• Qualified Infectious Disease Product (QDIP) Exclusivity: Exclusivity duration is of 5 yrs. It can be added to any existing exclusivity.
• Orphan Drug Exclusivity (ODE): Exclusivity duration is of 7 yrs
• Biologic Exclusivity: Exclusivity duration is of 12 yrs

Information provided by Chemxpert for Exclusivity

• Active Ingredients: Name of the chemical or active ingredient.
• Application Type: NDA (New Drug Application), ANDA (Abbreviated New Drug Application)
• Application Number: Application for exclusivity filing
• Exclusivity Expiry Date: It gives the date on which exclusivity is going to end.
• Trade name: It give the trade name(brand name) of the product
• Exclusivity Type: NCE, ODE, PED etc.

For Example: There are 3 registered companies for exclusivity of Paracetamol in our database. Information regarding one of them has been provided as under:

• Active Ingredients: Butalbital & Paracetamol
• Application Type: A (ANDA)
• Application Number: 213115
• Exclusivity Expiry Date: 2020-07-28
• Trade name: Butalbital & Paracetamol
• Exclusivity Type: CGT (Competitive Generic Therapy)