Mystery: is there a difference between ASTEPRO ALLERGY and Children’s ASTEPRO ALLERGY?

 Orange Book Insights No. 27 – Mystery: is there a difference between ASTEPRO ALLERGY and Children’s ASTEPRO ALLERGY?

Two nasal sprays containing azelastine hydrochloride were approved under NDA 213872 on June 17, 2021. They were named ASTEPRO ALLERGY (Prod. No. 001) and Children’s ASTEPRO ALLERGY (Prod. No. 002). Both have a strength of 0.2055mg/spray. The directions for use are also identical. For example, Prod. No. 001 has the same directions for use by children as Prod. No. 002. Similarly, Prod. No. 002 has the same directions for use by adults as Prod. No. 001. The inactive ingredients of the two versions are identical and listed in the same order.

What brought these products to my attention was the Supplement 7 “What’s New” of my Orange Book Companion. The “What’s New” showed that, after the June 17 approval of the both products, three patents were listed for Prod. No. 001, but none for the Prod. No. 002 “children’s” version. The claims of the three listed patents did not distinguish between adults and children.

So I asked the Orange Book Staff to look into this difference in the patent listings between the two products. I do not know if there was an oversight on the part of the NDA holder or the FDA, but the Orange Book Staff quickly added the same three patents to the patent listings for Children’s ASTEPRO ALLERGY (Prod. No. 002) that were already listed for ASTEPRO ALLERGY (Prod. No. 001).

Following that change, I was still curious about the difference between the two products. I think the answer to my question might be found in the fact that the June 17, 2021 approval of both products was an Rx-to-OTC switch. As a prescription product simply named ASTEPRO, it was up to the doctor to prescribe the Rx product to adults, or children as young as two years old, for seasonal allergy relief. So it was the doctors who brought Rx ASTEPRO to the attention of adult patients or the parents of children for whom a nasal spray allergy medication might be useful.

However, as an OTC product, how can the manufacturer gain the attention of a parent who is looking for an allergy medication for their child? Would it be sufficient for the ASTEPRO ALLERGY (Prod. No. 001) label to contain directions for children as young as six years old? Maybe not. What about drug stores who are showcasing children’s cough, cold and allergy OTC medications in a section that is separate from the adult OTC medications? Would the store employees know to stock ASTEPRO ALLERGY (Prod. No. 001) in the children’s section in addition to the adult section? Again, maybe not.

The answer, apparently, was to get the attention of parents and store employees by modifying the ASTEPRO ALLERGY (Prod. No. 001) label by simply adding the word “Children’s” in bright red above the words “ASTEPRO ALLERGY” at the top of the label, and also add “Age 6+” in red near the bottom of the label. Viola! Prod. No. 002 was born without the need to reformulate the product or modify any other parts of the label. Parents would immediately see that the product was for children, and store employees would know to stock the product on their “children’s” shelves. Clever!

#patents #fda #hatchwaxman  #drugpatents #orangebook #orangebookpatents #orangebookinsights


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