Para IV (US)

Para IV under ANDA encourages generic drug manufacturing companies to challenge patents. The generic company that files the first Abbreviated New Drug Application (ANDA) along with a Paragraph IV certification and wins in the lawsuit, gets a period of market exclusivity of 180 days.

For this duration of 180 days no other generic company can launch its product in the market. So, for the duration of six month there is no other manufacturer of the particular product except for the patented product company. Due to this arrangement, the generic company can earn higher profits for the period of six months until other generic manufacturers enter the market. The profits for the Para IV filing company can be even bigger if the product it challenges is a blockbuster or megabrand.

Information provided by Chemxpert for Para IV:

• Active Ingredients: Name of the chemical or active ingredient.
• Trade name: It give the trade name(brand name) of the product.
• Dosage form: It gives the dosage form of the product i.e. tablets, ointments, injections, capsules etc.
• Strength: It provides the various dosage strengths of the product.
• NDA number: It provides the NDA (New Drug Application) number of the product for which the patent was filed.
• Date of Para IV submission: It gives the date on which Para IV submission was made

For example:

There are 5 Para IV submitting companies for Paracetamol in our database. Information regarding one of them has been provided as under:

• Active Ingredients: Paracetamol
• Trade name: Tylenol
• Dosage form: Extended Release Tablet
• Strength: 650mg.
• NDA number: 19872
• Date of Para IV submission: N/A