A noninnovator multiple source drug is a type of medication that is not originally marketed under a new drug application. Instead, it is a drug that has therapeutic equivalents available from various manufacturers. This classification means that there are multiple sources for the same therapeutic effect, providing options for consumers and healthcare providers.
This term is primarily used in the context of pharmaceutical regulations and healthcare law. It is relevant in areas such as:
Users may encounter this term when dealing with healthcare forms or insurance claims related to prescription medications. Legal templates from US Legal Forms can assist individuals in navigating these processes effectively.
Here are a couple of examples of abatement:
For instance, a generic version of a brand-name medication like Lipitor may be classified as a noninnovator multiple source drug. This means that while Lipitor is the original brand, several other manufacturers produce generic versions that are therapeutically equivalent.
(hypothetical example) A patient may choose between several generic options for a medication, all of which are considered noninnovator multiple source drugs, allowing for cost-effective treatment alternatives.
The definition of noninnovator multiple source drugs is outlined in the federal statute 42 USCS § 1396r-8(k)(7)(A)(iii). This law specifies the criteria for classifying drugs under this term, particularly in relation to Medicaid reimbursement policies.
| Term | Definition | Key Difference |
|---|---|---|
| Innovator Multiple Source Drug | A drug marketed under an original new drug application. | It is the original brand drug, whereas a noninnovator is not. |
| Generic Drug | A drug that is equivalent to a brand-name drug in dosage form, strength, route of administration, quality, and performance characteristics. | Generic drugs can be noninnovator multiple source drugs, but not all are classified as such. |
If you are navigating prescription options and encounter noninnovator multiple source drugs, consider the following steps:
If your situation is complex, seeking assistance from a legal professional may be beneficial.
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It is a drug that is not originally marketed under a new drug application and has therapeutic equivalents available from various sources.