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Generic Empaveli Availability

Last updated on Jul 6, 2022.

Empaveli is a brand name of pegcetacoplan, approved by the FDA in the following formulation(s):

EMPAVELI (pegcetacoplan - solution;subcutaneous)

  • Manufacturer: APELLIS PHARMS
    Approval date: May 14, 2021
    Strength(s): 1080MG/20ML (54MG/ML) [RLD]

Has a generic version of Empaveli been approved?

No. There is currently no therapeutically equivalent version of Empaveli available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Empaveli. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
    Patent 10,035,822
    Issued: July 31, 2018
    Assignee(s): Apellis Pharmaceuticals, Inc.

    Long-acting compstatin analogs comprising a clearance-reducing moiety attached to two compstatin analog moieties, each compstatin analog moiety comprising a cyclic peptide extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a rigid or flexible spacer comprising an oligo(ethylene glycol) moiety, the clearance reducing moiety comprises a linear polymer, wherein each end of the linear polymer is linked to one of the compstatin analog moieties by way of a carbamate, wherein (i) the spacer comprises —(CH2)m— and —(O—CH2-CH2—)n joined covalently, wherein m is between 1 and 10 and n is between 1 and 10; and/or (ii) the spacer comprises 8-amino-3,6-dioxaoctanoic acid (AEEAc) or 11-amino-3,6,9-trioxaundecanoic acid.

    Patent expiration dates:

    • November 15, 2033
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  • Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof
    Patent 10,125,171
    Issued: November 13, 2018
    Assignee(s): Apellis Pharmaceuticals, Inc.

    In some aspects, the present invention provides cell-reactive compstatin analogs and compositions comprising cell-reactive compstatin analogs. In some aspects, the invention further provides methods of using cell-reactive compstatin analogs, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ. In some aspects, the invention provides long-acting compstatin analogs and compositions comprising long-acting compstatin analogs. In some aspects, the invention further provides methods of using long-acting compstatin analogs, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ. In some aspects, the invention provides targeted compstatin analogs and compositions comprising targeted compstatin analogs. In some aspects, the invention further provides methods of using targeted compstatin analogs, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ.

    Patent expiration dates:

    • August 2, 2033
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  • Patent 10,875,893

    Patent expiration dates:

    • November 15, 2033
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      Patent use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN
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      Drug substance
  • Patent 11,040,107

    Patent expiration dates:

    • April 9, 2038
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      Patent use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN TWICE WEEKLY
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      Drug product
    • April 9, 2038
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      Patent use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN EVERY THREE DAYS
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      Drug product
    • April 9, 2038
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      Patent use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 1080 MG OF PEGCETACOPLAN
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      Drug product
  • Patent 11,292,815

    Patent expiration dates:

    • November 15, 2033
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      Patent use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN SO AS TO REDUCE THE SENSITIVITY OF CELLS TO COMPLEMENT-DEPENDENT DAMAGE
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    • November 15, 2033
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      Patent use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF PEGCETACOPLAN
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  • Potent compstatin analogs
    Patent 7,888,323
    Issued: February 15, 2011
    Inventor(s): Lambris; John D. & Katragadda; Madan
    Assignee(s): The Trustees Of The University Of Pennsylvania

    Compounds comprising peptides and peptidomimetics capable of binding C3 protein and inhibiting complement activation are disclosed. These compounds display greatly improved complement activation-inhibitory activity as compared with currently available compounds.

    Patent expiration dates:

    • December 4, 2027
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      Drug substance
  • Compstatin analogs with improved activity
    Patent 7,989,589
    Issued: August 2, 2011
    Inventor(s): Lambris; John D.
    Assignee(s): The Trustees Of The University Of Pennsylvania

    Compounds comprising peptides and peptidomimetics capable of binding the C3 protein and inhibiting complement activation are disclosed. These compounds display improved complement activation-inhibitory activity as compared with currently available compounds. Isolated nucleic acid molecules encoding the peptides are also disclosed.

    Patent expiration dates:

    • December 4, 2027
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      Drug substance
  • Potent compstatin analogs
    Patent 9,169,307
    Issued: October 27, 2015
    Assignee(s): The Trustees of the University of Pennsylvania

    Compounds comprising peptides and peptidomimetics capable of binding C3 protein and inhibiting complement activation are disclosed. These compounds display greatly improved complement activation-inhibitory activity as compared with currently available compounds.

    Patent expiration dates:

    • November 18, 2027
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      Patent use: TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF COMPLEMENT INHIBITOR PEGCETACOPLAN
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Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • May 14, 2026 - NEW CHEMICAL ENTITY
    • May 14, 2028 - TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.