Applicant

The firm holding legal responsibility for the new drug application.

Trade Name

The trade name of the product as shown on the labeling.

Ingredient

The active ingredient(s) for the product.

Dosage Form

The product dosage form and route separated by a semi-colon. 

Biologic License Application (BLA) Number

The FDA-assigned number to the application.

Approval Date

The date the product was approved as stated in the FDA approval letter to the applicant.

Patent Number

Patent numbers as per pubic disclosures. Drugs may be protected by additional patents not included in BiologicPatentWatch.

Estimated Patent Expiration Date

The estimated date for patent expiration, which may not include all applicable extensions. 

Status

The group or category of approved drugs; Prescription (Active Rx), Over the Counter (OTC), or Discontined.

Orphan

The group or category of approved drugs; Prescription (Active Rx) or Discontined.