PXL/HO/Cir-026/2019-20                                                                                    Date: 25.06.2019

Hyderabad

Dear Sir/Madam,

Subject: List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic published by USFDA

We are pleased to inform the members that USFDA publishes the List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic to improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) for drugs with limited competition.

The list includes approved new drug applications (NDAs) for drug products that are not protected by patents or exclusivities at the time of the update, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product.

The agency updates this list every six months to ensure continued transparency regarding drug products where increased competition has the potential to provide significant benefit to patients.

While the object of USFDA is to increase the competition, our member companies would certainly weigh the business prospects in terms of time and money spent in developing an ANDA for those products and estimated returns.

The recent list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic published by USFDA is enclosed for information.

Thanking you

Yours sincerely

Udaya Bhaskar

Director General