Generic Empaveli Availability

Last updated on Apr 10, 2025.

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]

Is there a generic version of Empaveli available?

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.

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
Inventor(s): Francois Cedric & Deschatelets Pascal
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)— and —(O—CH2-CH2—)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
Inventor(s): Francois Cedric & Deschatelets Pascal
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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Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Patent 10,875,893
Issued: December 29, 2020
Inventor(s): Francois Cedric & Deschatelets Pascal
Assignee(s): Apellis Pharmaceuticals, Inc.
In some aspects, the present invention provides compositions and methods of treatment comprising long-acting compstatin analogs. In some aspects, long-acting compstatin analogs comprise a clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide comprising the amino acid sequence as set forth in SEQ ID NO: 28 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 spacer comprising 8-amino-3,6-dioxaoctanoic acid (AEEAc) moiety, the clearance reducing moiety comprises a polymer, wherein each end of the polymer is linked to one of the compstatin analog moieties by way of a linker moiety that is or comprises a carbamate, and wherein the polymer is a PEG having an average molecular weight of about 40 kDa.
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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Dosing regimens and related compositions and methods
Patent 11,040,107
Issued: June 22, 2021
Inventor(s): Grossi Federico & Deschatelets Pascal & Francois Cedric & Johnson Patrick & Vega Carolina
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., treat a complement-mediated disorder, 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 treat a complement-mediated disorder, 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 treat a complement-mediated disorder, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ.
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
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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 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
Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods
Patent 11,292,815
Issued: April 5, 2022
Inventor(s): Francois Cedric & Deschatelets Pascal
Assignee(s): Apellis Pharmaceuticals, Inc.
In some aspects, the present invention provides compositions and methods (e.g. methods of treating, preventing, making, etc.) comprising compstatin analogs. In some embodiments, compstatin analogs comprise a linear PEG moiety having a molecular weight of 40 kDa and coupled to each of two compstatin analog moieties; wherein each compstatin analog moiety is a CA28-AEEAc-Lys moiety, the linear PEG moiety is coupled to the Lys side chain of each CA28-AEEAc-Lys moiety via a carbamate and each CA28-AEEAc-Lys moiety is Ac-Ile-Cys*-Val-(1Me)Trp-Gln-Asp-Trp-Gly-Ala-His-Arg-Cys*-Thr-[NH-CH2CH2OCH2CH2OCH2-C(═O)]-Lys-NH2 (SEQ ID NO: 51); wherein the Cys* groups are joined by a disulfide bond.
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
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  Drug product
- 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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  Drug substance
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Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof
Patent 11,661,441
Issued: May 30, 2023
Inventor(s): Francois; Cedric et al.
Assignee(s): Apellis Pharmaceuticals, Inc. (Waltham, MA)
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:
- January 13, 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
Dosing regimens and related compositions and methods
Patent 11,844,841
Issued: December 19, 2023
Inventor(s): Grossi; Federico et al.
Assignee(s): Apellis Pharmaceuticals, Inc. (Waltham, MA)
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., treat a complement-mediated disorder, 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 treat a complement-mediated disorder, 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 treat a complement-mediated disorder, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ.
Patent expiration dates:
- December 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
- December 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
- December 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
Potent compstatin analogs
Patent 7,888,323
Issued: February 15, 2011
Inventor(s): Lambris; John D. et al.
Assignee(s): The Trustees Of The University Of Pennsylvania (Philadelphia, PA)
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 (Philadelphia, PA)
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
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:
- 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:
- February 8, 2026 - INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF STUDY APL2-308
- May 14, 2026 - NEW CHEMICAL ENTITY
- May 14, 2028 - TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)

More about Empaveli (pegcetacoplan)

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Paroxysmal Nocturnal Hemoglobinuria

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

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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Pill medicine is Empaveli 1080 mg/20 mL (54 mg/mL) injection — Empaveli 1080 mg/20 mL (54 mg/mL) injection