Abbreviated New Drug Application (ANDA)

Abbreviated New Drug Application (ANDA) provides a 180-day period of exclusivity to the first applicant who files for ANDA containing a paragraph IV certification to a listed patent.

An abbreviated new drug application (ANDA) covers data which is submitted to USFDA for the review & approval of a generic pharmaceutical drug. Once the generic drug manufacturing company gets the approval it can manufacture & sell the generic drug.

• When the exclusive rights enjoyed by innovator drug manufacturing company are expired due the patent term expiry a generic version of the product can be developed & launched by other companies.
• Applications for generic drug are called "abbreviated" because they usually do not need to include preclinical (animal) and clinical (human) data to prove their safety and efficacy. For this data they rely on the data provided by Innovator Company. It saves a very long amount of time taken to conduct these studies.
• However, generic applicants should prove that their product acts in the same way as the innovator drug they are following. One of the ways is to show & prove this is to comparing the time taken by the generic drug with that of innovative drug, to reach the bloodstream in selected group of people.

Information provided by Chemxpert for Abbreviated New Drug Application (ANDA)

• Active ingredients: Active ingredient of the drug
• Application No: Application no. for the approved drug through Abbreviated New Drug Application (ANDA)
• Approval date: Approval date of the product for Abbreviated New Drug Application (ANDA) by USFDA
• Market Status: Active (RX), over the counter or discontinued
• Proprietary Name: Trade name or the brand name of the product
• Application Holder: Individual, pharmaceutical manufacturing company, research institute or lab holding the exclusivity for the product by Abbreviated New Drug Application (ANDA)

For Example: In our database (Chemxpert) Paracetamol has 39 Formulated products available in Abbreviated New Drug Application (ANDA).