From 2009–2019, this difference in drug costs saved the U.S. healthcare system nearly $2.2 trillion, according to a report from the Association for Accessible Medicines.
This article lists drugs coming off patent in 2023 that will be available as generic drugs. It also discusses the benefits of generic drugs and their effectiveness compared to brand-name medications.
Brand-name patented drugs going generic in 2023
A few of the drugs potentially going generic in the coming year are biologics. Their generic versions would be considered biosimilars.
Biologics vs. biosimilars
The
A biosimilar is biologic medication that has no significant clinical differences from the original biologic. Biosimilars are administered the same way and are equally as effective as biologics.
However, because the original biologic has already undergone the full FDA-approval process, the path is streamlined for biosimilars. This allows them to come to market faster and at a lower cost.
This includes the blockbuster biologic Humira (adalimumab), which historically has been the highest-selling medication in the U.S. Because Humira is on the list, it could make 2023 a good test of the biosimilar market.
The U.S. has been slow to approve biosimilars, and market entry has been slow for many reasons, including patent lawsuits and pharmacy benefit manager rebates from biologic manufacturers. However, this could be changing.
Brand-name drugs that could be available as first-time generics or biosimilars due to patent expirations include the following.
| 2023 timing | Generic availability |
|---|---|
| January | Humira (adalimumab) Ibrance (palbociclib) Nascobal (cyanocobalamin intranasal) Teflaro (ceftaroline) Trokendi XR (topiramate) |
| February | Latuda (lurasidone) Vyvanse (Lisdexamfetamine) |
| March | Aggrastat (tirofiban) Aubagio (teriflunomide) Gattex (teduglutide) |
| April | Corlanor (Ivabradine) Edurant (rilpivirine) |
| May | Livalo (pitavastatin) |
| July | Mozobil (plerixafor) Qtern (dapagliflozin/saxagliptin) |
| December | Victoza (liraglutide) |
| sometime in 2023 | Iressa (gefitinib) Lexiscan (regadenoson) Lucentis (ranibizumab) Myrbetriq (mirabegron) Onglyza (saxagliptin) Prezista (darunavir) Prolensa (bromfenac 0.07%) Treanda (bendamustine HCl) |
While these drugs are nearing the end of their patent term, the release of generics may be delayed due to litigation, acquisitions, or other exclusivities. As a result, some expected generics from previous years may still be in progress.
Talk with your doctor about whether any prescribed medications are available as generics and if those options are right for you.
Generic drugs vs. brand-name drugs
With generic drugs, the saying “you get what you pay for” is just not so in most cases.
When the
- dosage form
- safety
- strength
- quality
- purity
- performance characteristics
- intended use
A generic drug may look or taste different or have different inactive ingredients compared with the brand-name drug. However, this is due only to trademark laws.
The FDA ensures generics work the same as their equivalent brand-name drugs. Generic manufacturers’ factories also must meet the same rigorous FDA standards as the brands’ factories.
Why generic drugs cost less
Generic drug manufacturer costs are much lower than those for brand-name drugs primarily because producers of generics do not pay for development and new-drug marketing.
The brand-name manufacturer does the upfront research and development work. In return, they get
Once the patent-protection term expires, generic equivalent drugs or biosimilar drugs can come to market.
When generic drugs come to market
Despite the 20-year patent protection, consumers usually do not have to wait a full 20 years for generic products to enter the market.
This is because the patent term starts when a drug manufacturer submits the application. However, in most cases, the brand name drug does not actually come to market until well into the 20-year term.
Other market exclusivities can be a way for manufacturers to extend access to the brand name only. These periods vary and are intended to balance innovation and public access.
Summary
Many brand-name drugs will become available in generic forms in 2023. Generic drugs can provide cost savings for consumers while still providing the same efficacy as brand-name medications.
If you are currently taking a brand-name medication or receive a prescription for one, talk with your doctor or pharmacist about available generic options and if they may be right for you.
