Authorized Generic vs. ANDA Generic
Since the recent launch of authorized generic albuterol inhalers, PAAS has received numerous requests for clarifications on substitution, therapeutic equivalence codes and DAW codes. PAAS Audit Assistance members can see our January 2019 article Generic Albuterol HFA Inhalers for additional background.
Q1: Is an Authorized Generic drug the same thing as a generic drug?
The FDA has a complete explanation on its website, here is an excerpt:
“No. The term “authorized generic” drug is most commonly used to describe an approved brand name drug that is marketed without the brand name on its label. Other than the fact that it does not have the brand name on its label, it is the exact same drug product as the branded product.”
Q2: How Is an Authorized Generic Drug Different from what Is Commonly Understood to Be a Generic Drug?
A generic drug is the same as the brand-name drug in active ingredient, conditions of use, dosage form, strength, route of administration, and (with certain permissible differences) labeling. To obtain approval of a generic drug, a company must submit an Abbreviated New Drug Application (ANDA) to the FDA and prove that its product is the same as the brand-name drug in the ways described above, and that it is “bioequivalent,” meaning it gets to the part of the body where the drug works at the same time and in the same amount.
An authorized generic drug is the same as the brand-name drug but does not use the brand name on the label. Because an authorized generic drug is marketed under the brand name drug’s New Drug Application (NDA), it is not listed in FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). An authorized generic is considered to be therapeutically equivalent to its brand-name drug because it is the same drug. This is true even if the brand-name drug is “single source,” meaning there are no ANDAs approved for that product, or coded as non-equivalent (e.g., BX) by FDA in the Orange Book
Q3: What DAW code do I need to submit when dispensing Ventolin®?
PAAS recommends that all prescriptions are transmitted with a default of DAW 0, unless the prescriber has indicated brand medically necessary (DAW 1) or the patient has requested the brand (DAW 2).
Q4: Can I substitute the Prasco albuterol HFA for Ventolin® when it has a “BX” therapeutic equivalence code?
Yes, as per Q2 above, authorized generics are “considered to be therapeutically equivalent to its brand-name drug because it is the same drug.” Since there are no ANDA generics available, the brand inhalers are still considered “single-source” and retain the BX codes.
Q5: What if the payer prefers the brand name inhaler?
PBMs may continue to prefer the brand name inhalers due to formulary/rebate agreements as the price drop for an authorized generic is often minimal. It is not until multiple ANDA generics enter the marketplace that this competition brings the price down to a point where it is cheaper to cover the generic. Payers may reject claims for “generic” (authorized or ANDA) at point-of-sale and provide messaging that they prefer brand. You may need to bill the brand NDC with DAW 0, DAW 9 or follow online claim messages. See March 2019 article What DAW Code Do I Bill on a Brand Product? for additional discussion.
Here are some details about recent authorized generic and ANDA generic launches.
Since there are no ANDA generics available, the albuterol inhalers are still considered “single-source” and have BX ratings. Note that the authorized generic has the same FDA application number as the referenced brand product.
|Product||NDC||Labeler||Package Size||FDA Application Number||TE Code|
|Ventolin® HFA||00173-0682-20||Merck||18 GM||N020983||BX|
|Albuterol sulfate HFA||66993-0019-68||Prasco||18 GM||N020983||BX|
|ProAir® HFA||59310-0579-22||Teva||8.5 GM||N021457||BX|
|Albuterol sulfate HFA||00093-3174-31||Teva/Mylan||8.5 GM||N021457||BX|
|ProVentil® HFA||00085-1132-04||Merck||6.7 GM||N020503||BX|
Additionally, there have been recent Authorized and ANDA generic launches of Advair Diskus® this year. Since there is an ANDA generic available, Advair is now considered “multi-source” and has an AB rating.
- ANDA generic WixelaTM InhubTM (made by Mylan) was approved on January 30, 2019
- Authorized generic (distributed by Prasco) was released February 8, 2019
See examples for the 100 mcg/50 mcg strength below:
|Product||NDC||Labeler||FDA Application Number||Source||TE Code|
|WixelaTM InhubTM||00378-0932-32||Mylan||A208891||ANDA Generic||AB|