Symbicort (budesonide/formoterol) is an inhaler sold by AstraZeneca. An estimated 2.7 million patients use the drug in the U.S. (1) While there are concerns about inappropriate use, the drug has been recommended for patients with moderate or severe chronic obstructive pulmonary disease and asthma in adults.
A history of environmental racism in the U.S. means that communities of color may have disproportionate need for Symbicort. Black and Indigenous people have the highest rates of asthma. (2) Black people are more than twice as likely to die from asthma as other groups. (3)
The list price for a 30-day supply of Symbicort ranges between $300-$350. (4) Even after insurance, the cost can be prohibitive. As one patient recalls,
I spend approximately 25% of my monthly income on medical expenses and prescription drugs… There have been issues with my prescriptions every time I fill them. One month, they’ll be covered, and the co-pays will be affordable. And then the next month, they wouldn’t be covered, and the cost would be in excess of $1,200. While some months, I was able to pay for my prescriptions out of pocket, some months, I would have to make the choice [to skip them]. And usually, that would be my asthma medication and inhalers. (5)
The inhaler is covered by a patent thicket. Nine patents are listed in the FDA Orange Book, with the latest expiring in 2029.
Table: Symbicort patents
| Patent Number | Patent Expiration (6) |
| 7,587,988 | 10/10/2026 |
| 7,759,328 | 07/29/2023 |
| 8,143,239 | 07/29/2023 |
| 8,387,615 | 09/26/2027 |
| 8,528,545 | 04/16/2029 |
| 8,575,137 | 07/29/2023 |
| 8,616,196 | 10/07/2029 |
| 8,875,699 | 05/10/2025 |
| 10,166,247 | 07/29/2023 |
The FDA has approved a generic version of the drug. (7) But patent monopolies have precluded its launch. A dispute over three patents has lasted more than three years. (8)
The U.S. government can help bring the generic online rapidly by using Section 1498. In exchange for reasonable compensation to AstraZeneca, the U.S. government could allow the generic product to come to market by using its government patent use authority. This could help produce significant savings, and improve access to the inhalers.
(1) https://clincalc.com/DrugStats/Drugs/BudesonideFormoterol.
(2) https://www.lung.org/research/trends-in-lung-disease/asthma-trends-brief/current-demographics
(3) https://www.cdc.gov/asthma/data-visualizations/mortality-data.htm#anchor_1569600183140
(4) https://www.mysymbicort.com/cost-assistance.html
(5) Erin Jackson-Hill, Stand Up Alaska, Make Meds Affordable Campaign Launch, https://www.youtube.com/watch?v=AR2jrSdToj8
(6) This includes six months pediatric exclusivity.
(7) https://newsroom.viatris.com/2022-03-16-Viatris-Inc-Announces-Receipt-of-the-First-FDA-Approval-for-Generic-Version-of-Symbicort-R-Inhalation-Aerosol,-Breyna-TM-Budesonide-and-Formoterol-Fumarate-Dihydrate-Inhalation-Aerosol-,-in-Partnership-with-Kindeva
(8) https://www.fiercepharma.com/drug-delivery/viatris-gets-shot-to-shed-infringement-claims-long-running-patent-kerfuffle-over