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Generic Parsabiv Availability

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

PARSABIV (etelcalcetide - solution;intravenous)

  • Manufacturer: KAI PHARMS INC
    Approval date: February 7, 2017
    Strength(s): 2.5MG/0.5ML (2.5MG/0.5ML) [RLD], 5MG/ML (5MG/ML) [RLD], 10MG/2ML (5MG/ML) [RLD]

Has a generic version of Parsabiv been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Parsabiv. 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 FAQs.

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.

  • Therapeutic agents for reducing parathyroid hormone levels
    Patent 8,377,880
    Issued: February 19, 2013
    Assignee(s): KAI Pharmaceuticals, Inc.
    Compounds having activity for lowering parathyroid hormone levels are described. In one embodiment, the compounds are comprised of a contiguous sequence of subunits, X1—X2—X3—X4—X5—X6—X7, wherein the X1 subunit comprises a thiol-containing moiety and the distribution of charge on the X2—X7 subunits provides the desired activity. Methods of using the compounds for treating hyperparathyroidism, bone disease and/or hypercalcemic disorders are also described, and in particular, methods for lowering plasma PTH and serum calcium are provided. The compounds can be used to treat subjects having, for example: primary, secondary or tertiary hyperparathyroidism; hypercalcemia of malignancy; metastatic bone disease; or osteoporosis.
    Patent expiration dates:
    • July 29, 2030
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      Drug substance
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      Drug product
  • Therapeutic agents for reducing parathyroid hormone levels
    Patent 8,999,932
    Issued: April 7, 2015
    Assignee(s): KAI Pharmaceuticals, Inc.
    Compounds having activity for lowering parathyroid hormone levels are described. In one embodiment, the compounds are comprised of a contiguous sequence of subunits, X1-X2-X3-X4-X5-X6-X7, wherein the X1 subunit comprises a thiol-containing moiety and the distribution of charge on the X2-X7 subunits provides the desired activity. Methods of using the compounds for treating hyperparathyroidism, bone disease and/or hypercalcemic disorders are also described, and in particular, methods for lowering plasma PTH and serum calcium are provided. The compounds can be used to treat subjects having, for example: primary, secondary or tertiary hyperparathyroidism; hypercalcemia of malignancy; metastatic bone disease; or osteoporosis.
    Patent expiration dates:
    • July 29, 2030
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      Patent use: A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT)
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      Drug substance
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      Drug product
  • Therapeutic agents for reducing parathyroid hormone levels
    Patent 9,278,995
    Issued: March 8, 2016
    Assignee(s): KAI PHARMACEUTICALS, INC.
    Compounds having activity for lowering parathyroid hormone levels are described. In one embodiment, the compounds are comprised of a contiguous sequence of subunits, X1-X2-X3-X4-X5-X6-X7, wherein the X1 subunit comprises a thiol-containing moiety and the distribution of charge on the X2-X7 subunits provides the desired activity. Methods of using the compounds for treating hyperparathyroidism, bone disease and/or hypercalcemic disorders are also described, and in particular, methods for lowering plasma PTH and serum calcium are provided. The compounds can be used to treat subjects having, for example: primary, secondary or tertiary hyperparathyroidism; hypercalcemia of malignancy; metastatic bone disease; or osteoporosis.
    Patent expiration dates:
    • July 29, 2030
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      Drug substance
  • Therapeutic agents for reducing parathyroid hormone levels
    Patent 9,701,712
    Issued: July 11, 2017
    Assignee(s): KAI Pharmaceuticals, Inc.
    Compounds having activity for lowering parathyroid hormone levels are described. In one embodiment, the compounds are comprised of a contiguous sequence of subunits, X1—X2—X3—X4—X5—X6—X7, wherein the X1 subunit comprises a thiol-containing moiety and the distribution of charge on the X2-X7 subunits provides the desired activity. Methods of using the compounds for treating hyperparathyroidism, bone disease and/or hypercalcemic disorders are also described, and in particular, methods for lowering plasma PTH and serum calcium are provided. The compounds can be used to treat subjects having, for example: primary, secondary or tertiary hyperparathyroidism; hypercalcemia of malignancy; metastatic bone disease; or osteoporosis.
    Patent expiration dates:
    • July 29, 2030
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      Patent use: A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT)
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      Drug substance
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      Drug product
  • Stable liquid formulation of AMG 416 (etelcalcetide)
    Patent 9,820,938
    Issued: November 21, 2017
    Assignee(s): Amgen Inc.
    A liquid formulation comprising a peptide agonist of the calcium sensing receptor and method of preparing and using the formulation are provided.
    Patent expiration dates:
    • June 27, 2034
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      Drug product

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 7, 2022 - NEW CHEMICAL ENTITY
Glossary
TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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