New drugs approved by the Food and Drug Administration are protected by patents and go by their brand names.
A company that develops a new drug receives exclusive rights to sell the drug for months or years when it receives FDA approval. Companies that develop drugs for rare diseases typically have longer exclusivity rights to sell the drug than those that make medications for more common conditions.
Once the exclusivity period ends, other companies can develop and market equivalent versions of the same medication. The equivalent version is usually called a generic. If the original drug uses proteins, antibodies or other components from a living organism, then the equivalent drug is called a biosimilar.
FDA has strict criteria for generic and biosimilar equivalents of brand medications.
Generic availability
Your ability to switch to a generic pulmonary arterial hypertension therapy depends on several factors, including:
What you pay for brand PAH therapy vs. its generic counterpart depends on the medication price and how much your health insurance plan will pay.
Some plans may place a generic PAH therapy in the same cost bracket or tier as the brand drug, rather than in a lower-cost generic tier. Patients’ out-of-pocket responsibilities could shift as plan administrators better understand price differences between the two drugs and change the category for the generic.
Some health insurance plans update their formularies more quickly than others. Commercial plans tend to make them available more quickly than public programs like Medicaid.
Commercial insurance
If you have commercial insurance, you may receive financial assistance through a copay card from the company that makes your PH drug. Brand and some generic manufacturers both provide copay cards, but not all manufacturers provide the same amount of assistance. Some states or insurance policies may restrict you from using brand copay cards when a generic drug is available.
Medicare Part D
If your PH therapy is covered under Medicare Part D, your monthly out-of-pocket costs will vary over the year. As of 2026, Medicare beneficiaries have a $2,100 annual cap on their out-of-pocket costs for their Part D-covered drugs. Beneficiaries also can opt in to the Medicare Prescription Payment Plan, which allows people to spread out costs each month.
Charitable assistance organizations often offer grants to help people pay for brand and generic medications. Some are exclusive to Medicare and Medicaid beneficiaries, while others are available to all insurance types. However, most foundations require you to have some form of insurance to qualify for their assistance fund.
Some states allow pharmacies to transition patients to generic versions of brand drugs without consulting you or your physicians. Other states require pharmacies to notify you in all instances, and still others require it only in some circumstances. Medicare doesn’t require pharmacies to notify beneficiaries when they change to a generic from a brand drug.
Your PH care team, specialty pharmacy or drug manufacturer might be able to help you advocate for appropriate coverage of the drug you need.
If you and your health care professional decide that it is best for you to stay on the brand version of a therapy, a prescription marked, “dispense as written” can be an important tool. Your ability to switch to a generic pulmonary arterial hypertension therapy depends on several factors, including:
Are you considering switching to a generic?
Consider these questions when navigating between brand and generic therapy:
- What is the difference in my out-of-pocket cost for my current medication compared to the generic equivalent?
- Will I still be eligible for copay assistance if I can change to generic therapy?
- If I currently receive support services such as those from a nursing help line from a specialty pharmacy, drug manufacturer or other source, will I receive the same services for a generic drug?
- Do I have a “dispense as written” or “generic substitution permitted” prescription? If my insurance company requires me to transition to a generic therapy, will my prescription be filled as written? Or could my treatment be disrupted?