Is there a generic form of ZubSolv available on the market yet?
ZubSolv is a prescription medication that is FDA-approved for the treatment of opioid dependence. ZubSolv tablets contain two medications.
The first ingredient in ZubSolv, and the most important one, is buprenorphine. Buprenorphine is a mixed partial opioid agonist and opioid antagonist.
The second ingredient, which serves only as an abuse deterrent, is naloxone. The ZubSolv tablet is intended to be dissolved under the tongue, where the buprenorphine is absorbed, and most of the naloxone is not absorbed.
The purpose of the naloxone is to prevent drug abusers from trying to inject ZubSolv tablets into a vein. The buprenorphine in ZubSolv prevents opioid withdrawal symptoms and opioid cravings.
While there is not currently a generic form of ZubSolv available just yet, many patients who are prescribed ZubSolv have asked if there will be a ZubSolv generic, and when it might come out.
What are the advantages of ZubSolv over Suboxone?
If you are familiar with Suboxone, you may have noticed that ZubSolv has the same ingredients and works the same way as Suboxone. There are currently both generic Suboxone tablets and generic Suboxone films.
Patients are able to fill prescriptions for the low cost generic Suboxone strips or pills. Yet, there are still no generic ZubSolv pills, even though ZubSolv has been on the market for many years.
There are multiple advantages of ZubSolv over Suboxone and Subutex, as follows:
- ZubSolv has a pleasant minty taste with no aftertaste.
- ZubSolv is available in many dosages.
- ZubSolv dissolves very quickly under the tongue.
- And, one of the best advantages is that Orexo, the manufacturer, provides a voucher for up to 30 free tablets.
There are also disadvantages to ZubSolv compared to other sublingual buprenorphine medications.
- ZubSolv is expensive and sometimes difficult to get approved by insurance.
- There is no Generic ZubSolv.
- Many pharmacies do not carry ZubSolv and are not willing to order it.
- The dosages of ZubSolv can be confusing, since they do not match up with other similar medications.
To explain that last point, because ZubSolv has a higher bioavailability compared to Suboxone, according to the manufacturer, they have chosen to set the dosage amounts at different levels to make them equivalent to the commonly used Suboxone dosages. For example, Suboxone 8/2 mg is about equal in strength to ZubSolv 5.7/1.4 mg.
Suboxone 8 mg and Subutex 8 mg are so commonly used, that ZubSolv 5.7 mg is a confusing number for many people. And, it seems like it would be weaker, even though it works about the same.
Why is there no generic ZubSolv available yet?
An interesting aspect of ZubSolv is that there is nothing innovative about it beyond the delivery system. It is the same exact ingredients found in Suboxone brand films and generic Suboxone strips and pills.
I am not certain if it would make sense for there to be a generic of ZubSolv. Pharmacies already have generic sublingual buprenorphine/naloxone tablets available.
These tablets are essentially ZubSolv generics, even though we consider them to be Suboxone generics. Generic buprenorphine tablets come in a variety of sizes, shapes, and colors. Some dissolve faster than others. And, some taste worse than others.
There was even a legal case where Orexo tried to block generic tablets, because they would infringe on the ZubSolv patent, even though they could be thought of as Suboxone generics. While we may not see a minty-tasting, fast dissolving generic buprenorphine/naloxone tablet that is very similar to ZubSolv, there are already generic tablets with the same ingredients on the market.
You may wonder why ZubSolv exists as a separate product from Suboxone. ZubSolv was released while Suboxone was still protected by its patent.
Why did the manufacturer of Suboxone not try to block the release of ZubSolv when it was new?
I am not sure if there was such a patent battle. I am not always up to date on the various battles between drug manufacturers, which are often intended to maximize profits and make drugs more difficult for consumers to afford.
I would not be surprised if Indivior, the maker of Suboxone, did make an attempt to block ZubSolv from final FDA approval. When ZubSolv was released in 2013, Suboxone was the major brand of buprenorphine approved for treating opioid dependence.
Indivior has maintained its dominance by using its orphan drug status to defend its patents on buprenorphine medications. Similarly, Indivior is currently keeping the long-lasting buprenorphine injection, Brixadi, off the market. They are defending Sublocade, the only currently available buprenorphine subcutaneous injection in the US.
What if we already had a ZubSolv generic and didn’t even know it?
Currently, compound pharmacies already make sublingual preparations of buprenorphine. These bupe troches, as they are known, dissolve under the tongue, just like a ZubSolv pill. And, the compounded troches can be flavored to taste better, and they can be made to order, in any dosage, from 0.25 mg, all the way up to 8 mg, or more.
Compounded buprenorphine from these specialized pharmacies take care of most of the benefits of ZubSolv. They taste better than Suboxone, and they are available at the strength needed by individual patients.
The only area where compounded bupe falls short is that it is not, in most cases, covered by insurance. While most insurance plans will not cover ZubSolv, with Suboxone generic strips and pills now available, some plans do prefer ZubSolv.
ZubSolv is an anomaly in the world of prescription drugs.
First, there are few medications that are intended to be dissolved under the tongue. ZubSolv is a special tablet made to address some of the issues with sublingual administration.
It tastes better than other manufactured sublingual buprenorphine films or tablets, and it dissolves quickly. Most people when it comes to making financial decisions, would not pick ZubSolv if they had to pay for their prescription.
When price differences might be hundreds of dollars apart, between a month of ZubSolv and a month of generic Suboxone, many people will choose the generic, even if it tastes bad and dissolves slowly. Saving money on prescriptions is important to people.
Someday, Orexo may decide to stop making ZubSolv if interest is not high enough to justify manufacturing it. Still, the company should be commended for maintaining their free voucher offer for so many years.
While Indivior has dropped their patient assistance program and offers few price breaks, patients have always had the ZubSolv free 30 tablet offer to fall back on. I wonder how many lives Orexo has helped to save by making this offer available over the years.
Back when Indivior was fighting the release of generic Suboxone films and patients could not get health care insurance to cover overpriced Suboxone, ZubSolv and Orexo were there with the free 30 tablet offer to get patients started on life-saving treatment right away.,
In any future legal battles between Orexo and Indivior and other buprenorphine manufacturers over the patent status of their addiction treatment drugs, judges should take into account the aid that Orexo has provided, and the lives saved by making sure that anyone can afford their first prescription of buprenorphine/naloxone.