Major manufacturers of generic dextroamphetamine
Several pharmaceutical companies produce and market generic dextroamphetamine products. These can include formulations of pure dextroamphetamine sulfate (a generic for Dexedrine) or a mixture of amphetamine salts that includes dextroamphetamine (a generic for Adderall). Key players with FDA-approved products include Teva Pharmaceuticals, Mallinckrodt, Aurobindo Pharma, and Tris Pharma.
- Teva Pharmaceuticals (includes Actavis Elizabeth): Teva is a significant producer in the generic market. The company has received FDA approval for both generic mixed amphetamine salts (generic Adderall XR) and dextroamphetamine sulfate extended-release capsules.
- Mallinckrodt (includes SpecGx LLC): This manufacturer produces dextroamphetamine sulfate tablets (immediate-release) and extended-release capsules. It is well-known in the stimulant market for its various products. Some patients report differences in experience between different generics, which may be related to inactive ingredients.
- Aurobindo Pharma (includes Aurolife Pharma): Aurobindo is another company producing generic dextroamphetamine, available in different formulations. Patient anecdotes suggest that some individuals may react differently to Aurobindo's products due to specific inactive ingredients, emphasizing the potential for variation between generic versions.
- Tris Pharma: Known for specializing in drug delivery technologies, Tris Pharma launched the first-to-market generic equivalent of ProCentra®, a dextroamphetamine sulfate oral solution. The company has a history of developing specialty generics.
- Other Manufacturers: The market also includes manufacturers like Impax Laboratories, Strides Pharma, Sandoz, and Epic Pharma, which produce various amphetamine-related products.
Generic equivalence vs. brand-name differences
When a drug goes generic, the FDA requires that the generic version contain the same active ingredient and be bioequivalent to the brand-name version. This means it must deliver the same amount of the active ingredient to the bloodstream over the same period. However, generic versions are allowed to use different inactive ingredients, such as fillers, binders, and coloring agents.
Inactive Ingredients and Patient Experience The difference in inactive ingredients is a critical point for some patients. For the vast majority, this has no discernible effect. However, a small percentage of individuals may be sensitive to a particular filler or binder used by one manufacturer. This can lead to a slightly different side effect profile or a perceived change in efficacy, as noted in online patient discussions. Because of this, some patients may find they tolerate one generic brand better than another. A healthcare provider can help navigate these preferences, and your pharmacy can often check which manufacturer's product is currently in stock.
Factors affecting supply and availability
Generic dextroamphetamine products are Schedule II controlled substances, which means they have a high potential for abuse and are subject to strict regulatory control by the Drug Enforcement Administration (DEA). The DEA sets annual production quotas for controlled substances, which can influence supply.
- DEA Quotas: The DEA establishes yearly quotas for amphetamine-related compounds to control distribution. If demand exceeds the initial quota, or if there are manufacturing delays, shortages can occur. While the DEA has noted that quotas have not always been fully utilized, other factors can still impact availability.
- Manufacturing Delays: Like any medication, manufacturing issues, sourcing of raw materials, or distribution problems can cause temporary shortages. Reports have noted delays from manufacturers as a contributing factor to supply issues.
- Increased Demand: The diagnosis and treatment of ADHD have increased significantly in recent years, leading to higher demand for stimulant medications. This increased demand can strain the supply chain, especially if DEA quotas do not keep pace.
Comparing generic dextroamphetamine manufacturers
This table provides a generalized comparison of some known manufacturers of generic dextroamphetamine, noting potential differences in formulation (IR vs. ER) and highlighting the inactive ingredient variance.
| Feature | Teva / Actavis | Mallinckrodt / SpecGx | Aurobindo / Aurolife | Tris Pharma |
|---|---|---|---|---|
| Product Type(s) | Extended-release capsules (generic Adderall XR, generic Dexedrine ER), tablets | Immediate-release tablets, extended-release capsules | Immediate-release tablets, extended-release capsules | Oral solution (generic ProCentra®) |
| Inactive Ingredients | Varies by product; differs from brand name | Varies by product; differs from brand name | Varies by product; differs from brand name | Varies by product; differs from brand name |
| Potential for Variation | Some patients report different experiences with different generic brands | Known patient reports of perceived differences compared to other generics | Known patient reports of perceived differences compared to other generics | Specific oral solution delivery system |
| Available Formulations | Mixed amphetamine salts (generic Adderall XR), dextroamphetamine sulfate ER | Dextroamphetamine sulfate IR/ER | Dextroamphetamine sulfate IR/ER | Dextroamphetamine sulfate oral solution |
Tips for managing generic switches
If you are a patient concerned about switching generic manufacturers, here are some steps you can take:
- Communicate with your pharmacy: Ask your pharmacist which generic manufacturer's product they carry before filling your prescription. They can often tell you if their supplier has switched recently.
- Consult your physician: Discuss any perceived differences in effects or side effects with your doctor. Your physician can work with you to determine if a specific generic is working best for you.
- Report issues to the FDA: If you experience any adverse effects or believe a generic medication is not working as expected, you can report it to the FDA's MedWatch program. This helps the FDA monitor the safety and effectiveness of generic drugs.
Conclusion
Many pharmaceutical companies, including Teva, Mallinckrodt, and Aurobindo, manufacture generic dextroamphetamine, offering affordable alternatives to brand-name versions like Dexedrine and Adderall XR. While all FDA-approved generics are bioequivalent and contain the same active ingredients, differences in inactive ingredients can impact some patients. Factors such as DEA quotas and manufacturing delays can influence the availability of these controlled substances. It is important for patients to communicate openly with their healthcare providers and pharmacists to ensure consistent, effective treatment when a generic manufacturer changes. Patients who notice a significant change in effect can request a different manufacturer or report their experience to the FDA to help ensure drug safety and efficacy across the market. The FDA's DailyMed provides official labeling information for many of these products.
Frequently asked questions about generic dextroamphetamine
How is generic dextroamphetamine different from brand-name Dexedrine?
Generic dextroamphetamine contains the same active ingredient, dextroamphetamine sulfate, as the brand-name drug, Dexedrine. The primary differences typically lie in the inactive ingredients, the pill's appearance (color, shape, markings), and the significantly lower cost of the generic version.
Do all generic versions of dextroamphetamine work the same?
All FDA-approved generic versions are required to be bioequivalent, meaning they deliver the same amount of the active medication to the bloodstream in the same way. However, some patients report subtle differences in effects or side effects due to varying inactive ingredients used by different manufacturers.
Can I request a specific manufacturer's generic dextroamphetamine from my pharmacy?
While pharmacies may not carry all generic manufacturers' products, you can ask your pharmacist if they can order a specific brand or check their inventory. It is best to communicate your needs clearly and work with your healthcare provider to find the most suitable option.
Why does the appearance of my generic dextroamphetamine change sometimes?
This is common with generic drugs and usually occurs when your pharmacy switches suppliers or a different manufacturer is used to fill your prescription. Because inactive ingredients can differ, the appearance of the pill or capsule (color, shape, markings) can also change.
Is generic dextroamphetamine sulfate the same as generic Adderall?
No. Generic dextroamphetamine sulfate is the generic version of Dexedrine and contains only dextroamphetamine. Generic Adderall, or generic mixed amphetamine salts, contains a combination of four different amphetamine salts, including both dextroamphetamine and levoamphetamine.
Why is there sometimes a shortage of generic dextroamphetamine?
Shortages can be caused by various factors, including manufacturing delays, issues with sourcing raw materials, or DEA quotas for controlled substances. The DEA regulates the production of these drugs, which can sometimes impact supply.
What should I do if I think my generic medication is not working as well as another?
If you notice a change in how your medication is working, the first step is to contact your prescribing doctor. They can help you evaluate the situation and may recommend checking if a different generic manufacturer is available or adjusting your treatment plan. You can also report your experience to the FDA's MedWatch program.
