Even though the slowdown in ANDA approvals, attributable to the issues of elemental impurities, has dampened the first two month of 2018 (here), the number of first-time generic ANDA approvals seems to be higher than would be expected. FDA reported 10 first-time generics (note that there may be multiple reports for the same drug if multiple applicants obtain approval on the same day) through March 8, 2018 so far this calendar year.
First-time generic approvals are great for both the industry and the consumer, right? In most cases yes because it introduces a first-time generic option that is always lower in price than the brand name counterpart it copies. Single first-time approval can save 15-20% off brand name prices and can provide lower co-pays for insured patients. Once the field gets more crowded with approvals – say there are 6 – 10 or more approved applications-the price can fall to 90% of the brand name drug in a very short period of time due to fierce competition.
Now that sounds like all good news for the consumer, but not all generics are marketed right after approval. Some firms may have to perform final validation studies on their commercial manufacturing process. In some instances, some problems occur with an active pharmaceutical ingredient supplier or the current approved manufacturing site that requires a change after approval and before marketing commences. But there is another daunting issue facing some applicants.
Remember, FDA may approve an ANDA containing a patent challenge (a so-called PIV ANDA) 30-months after the generic company provides notice to the patent holder and the ANDA applicant stating the basis of the reasons they believe the patent is invalid, not infringed by their product, or is unenforceable. Even though the firm may obtain ANDA approval from FDA after the expiration of the “30-month stay” and prior to resolution of the patent litigation, the ANDA applicant may not wish to commence marketing until the patent case is favorably resolved for the ANDA sponsor. The Pink Sheet on March 14th, reported on once such case by noting: “…Despite the US FDA’s approval of two generic versions of Amgen Inc.’s Sensipar (cinacalcet), competition to the branded calcium-sensing receptor agonist may await the outcome of patent litigation in a Delaware federal court.”
Firms do have the option of going to market once FDA is approval is received and prior to resolution of the patent litigation; however, if they eventually lose the patent case, their ANDA approval will likely be rescinded, their application will go back to pending status, and the firm could be liable for treble damages, a potentially “lose the firm” outcome.
So, while first generic approvals are generally great for consumers, when news of their approval hits the press, the impact may be delayed if patent litigation has not concluded or some other issue keeps the firm from launching its product immediately.
