Generic Medicines List 2021 PDF

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List of Generic Medicines 2021

Generic drugs are medications that have been created to look and perform the same as a brand-name medication. Generic medicines work in the same manner and provide the same clinical benefits as the brand-name versions.

Metformin is an example of a generic drug. It’s used to treat diabetes. Glucophage is a brand name for metformin. Glucophage is a brand name for metformin. Generic names are not capitalized. Metoprolol is a generic drug that is used to treat hypertension. Lopressor is a brand name for the exact same drug

How can FDA ensure that generic medicines perform the same way as brand-name medications?

Generic medicines must work in the same way as brand-name medications. It must perform the same functions as brand-name medicines in terms of dosage, form, route of administration, safety and strength, labeling and labeling (with some exceptions). It must meet the same quality standards as brand-name products in manufacturing and quality. This applies to all generic medications.

Generic medicines have the exact same active ingredients and function in the same way as brand-name medications. They also offer the same benefits and risks as brand-name drugs. After generic medicines are approved and put on the market, the FDA Generic Drugs Program inspects manufacturing plants and monitors drug safety.

Generic drugs may be slightly different from brand-name products, such as having different active ingredients.

It is important that you remember that there will always be slight variations in the expected outcome, although not significant for medical purposes. This is just like what happens with a brand-name medicine and a brand-new product. Both generic and brand-name medicines can experience this variability during manufacturing. Generic or brand-name medicines are mass produced and allow for very small variations in purity, strength, size, and other parameters. FDA has a limit on the amount of variability that is permissible.

A large study1 that compared generics and brand-name medications found very little difference in the absorption of generic and brand-name drugs. Some generics were absorbed slightly differently to others. This is clinically acceptable and expected for any brand-name medicine compared to another brand-name medicine or generic medicine compared with a brand-name medication.

Additional Resource

Research Study: Comparative clinical efficacy of brand-name and generic drugs in the treatment of cardiovascular diseaseAn analysis of 38 clinical trials published in the journal showed that generic heart medications performed no better than brand-name medicines.

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What makes a generic drug different from a brand-name drug?

The United States has strict trademark laws that prohibit generic drugs from looking exactly like the other drugs on the market. Generic medicines and brand name medicines share the same active ingredients, but there may be other characteristics such as colors or flavorings that do not compromise the performance, safety, and effectiveness of the generic medication.

Additional Resource

Generic drugs are important because of their physical properties
You can read a discussion about FDA’s guidance that recommends generic applicants create and develop generic drugs of a similar shape and size to brand-name products.

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Generic medicines are often cheaper than brand-name medications.

FDA must review generic drugs before approval. This is done after the product has been on the marketplace exclusively for a certain time. Patents protect new drugs and other products.

Generic drugs are generally cheaper than brand-name medications because they don’t have to undergo the same animal and human studies as brand-name medicines in order to prove safety and effectiveness. This abbreviated pathway is why the application is called an “abbreviated new drug application.”

Generic medicines are often sold at significant discounts. They have a similar therapeutic effect to their branded counterparts but they cost 80-85% less than the brand-name medication. The IMS Health Institute estimates that generic drugs have saved nearly $2.2 trillion in healthcare costs between 2009 and 2019.

Multiple generic companies can market a single product. This creates more competition in the marketplace which results in lower prices for patients.
FDA has made it a top priority to increase drug competition and reduce the high price of medicines. FDA released the Drug Competition Action Plan in 2017 to encourage more generic drug competition and improve efficiency of the generic drug review process. However, this plan does not compromise the scientific rigor that underpins our generic drug program.

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What criteria must generic medicines be approved by the FDA?

To market a generic drug, drug companies must submit an abbreviated drug application (ANDA), to FDA in order to get approval. FDA reviews each application to verify that drug companies have shown that the generic medicine can replace the brand-name medicine it copies.

ANDAs must prove that the generic medicine is equivalent in the following ways

  • The active ingredient is identical to that of the brand name drug/innovator drugs.
    • A medicine’s active ingredient is the part that is pharmaceutically active and is effective against the condition or illness it treats.
    • FDA must examine scientific evidence from generic drug companies that prove their active ingredient is identical to the brand-name medicine copied.
  • Generic medicine has the same strength.
  • The medicine is the exact same product, such as a tablet or injectable.
  • The same route of administration for the medicine (oral or topical) is used.
  • It is the same as its use indications.
  • Acceptable inactive ingredients are the medicines.
    • There are some differences between generic and brand-name products that must be proven to not have any effect on the medicine’s function.
    • FDA must examine evidence submitted by generic drug companies to show that the ingredients in their products meet FDA standards.
  • It lasts at least the same time.
    • Most medicines break down, or deteriorate, over time.
    • Generic drug companies have to conduct months-long stability tests in order to prove that their products can last at least as long as brand-name products.
  • It is produced under the exact same standards as brand-name medicines.
    • It meets all the batch requirements for quality, identity, strength, purity, consistency, and quality.
    • The manufacturer can make the medicine accurately and consistently.
      • Generic drug manufacturers must describe how they plan to manufacture the medicine. They must also show that every step of the manufacturing process will yield the same result every time. FDA scientists review these procedures and FDA inspectors visit the facility of the generic drug manufacturer to confirm that they are capable of manufacturing the medicine consistently. They also verify that FDA has accurate information.
      • Many times, multiple companies are involved. For example, one company may be manufacturing the active ingredient while another company manufactures the finished medicine. For FDA review, generic drug manufacturers must produce batches and disclose information about their manufacturing process.
  • It is important to choose the right container in which the medicine will arrive and be sold.
  • The label looks exactly the same as the label for brand-name medicines.
    • The generic drug information label should be identical to the brand-name label. If the brand-name drug has been approved for multiple uses and those uses are protected by exclusivities or patents, there is an exception. Generic medicines can be approved for any use that isn’t protected by patents and exclusivities. However, this does not mean that they will not be approved for safe use. Generic medicines labels can contain changes if the drug is manufactured by another company.
  • These patents and exclusivities can be addressed.
    • Drug companies receive patents and exclusivities as incentives to develop new medicines. FDA may not approve generic medicine applications if they delay approval. FDA must adhere to the restrictions imposed by patents and exclusivities on FDA approval.
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However, the ANDA process doesn’t require drug applicants to conduct costly animal and human studies on existing approved ingredients and dosage forms. This allows generic medications to be made more quickly and at a lower price, which will allow for greater access for the public to medication.

Additional Resources

What is the Approval Process for Generic Medicines?
This information contains detailed information about the FDA’s critical factors that are used to ensure that generic medicines are as safe as brand-name drugs.

CDER Conversation: Generic Drug Approval Process
Ted Sherwood, Director of the Office of Regulatory Operations at the Office of Generic Drugs, Center for Drug Evaluation and Research, discusses how FDA reviews generic drugs.

What makes a generic drug the same as a brand-name drug?
Download ahigh-resolution, printable PDFThis infographic is available in PDF – 431 Kbimg alt=”What is the difference between a generic and a brand-name drug?” src=”https://www.fda.gov/files/What%20makes%20a%20Generic%20Drug.jpg” title=”What makes a generic the same as a brand name drug? “/>

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Is there a generic version of my brand-name medication?

There are three ways you can find out if there’s a generic version of your brand-name medication.

  • UseDrugs@FDAThe FDA’s approved drug products list, with their drug labels, is available at www.fda.gov.
    • Start by searching for the brand name.
    • Second, choose the brand name product you wish to purchase and note the products listed in the section titled “Therapeutic Equivalents “
    • Generic products are those that have an ANDA number (not NDA), next to their name.
  • The online version of the document is available hereOrange Book.
    • Search by brand or proprietary first. Pay attention to the active ingredient name.
    • The second step is to search for the active ingredient again.
    • Scroll down to see the strength and dosage form, such as tablet.
    • Scroll down to the TE Code column. FDA approves generic equivalents if the TE column begins with “A”.
    • Look at the column “Appl Number”. If the letter A appears before the number, it is an FDA-approved generic version of the brand-name medication.
    • For very recent approvals, consult First Generic Drug Approvals.
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You may not be able to find a generic version of your brand-name medication. This is because the drug companies can recoup the costs they incurred for initial research and marketing the innovator or brand-name drug. FDA cannot approve generics of brand-name medicines until both the patent and other exclusivity periods have been resolved.

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How does FDA monitor side effects and safety concerns with generic medicines?

FDA takes many steps to ensure safety and quality both before and after the approval of a generic or new medicine. FDA reviews all generic drug applications and examines the submitted data. FDA also inspects the manufacturing facilities and related testing to make sure that generic drugs are safe, effective, reliable, and comparable to brand-name drugs.

FDA staff monitors all approved drugs, including generics, to ensure that all medicines are safe, effective and of high quality at all levels of supply chain.

FDA also monitors patient reactions and reports of adverse side effects. FDA may recommend changes to the manufacturing or use of a product, both brand-name and generic.

MedWatch is the FDA’s medical product safety reporting program. Health professionals, patients and consumers can use MedWatch to voluntarily report a serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that is suspected to be associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic.

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