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Generic Sensipar Availability

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

SENSIPAR (cinacalcet hydrochloride - tablet;oral)

  • Manufacturer: AMGEN
    Approval date: March 8, 2004
    Strength(s): EQ 30MG BASE [RLD] [AB], EQ 60MG BASE [RLD] [AB], EQ 90MG BASE [RLD] [AB]

Has a generic version of Sensipar been approved?

A generic version of Sensipar has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Sensipar and have been approved by the FDA:

cinacalcet hydrochloride tablet;oral

  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: March 8, 2018
    Strength(s): EQ 30MG BASE [AB], EQ 60MG BASE [AB], EQ 90MG BASE [AB]
  • Manufacturer: CIPLA
    Approval date: March 8, 2018
    Strength(s): EQ 30MG BASE [AB], EQ 60MG BASE [AB], EQ 90MG BASE [AB]
  • Manufacturer: MYLAN
    Approval date: October 16, 2018
    Strength(s): EQ 30MG BASE [AB], EQ 60MG BASE [AB], EQ 90MG BASE [AB]
  • Manufacturer: PIRAMAL HLTHCARE UK
    Approval date: August 1, 2018
    Strength(s): EQ 30MG BASE [AB], EQ 60MG BASE [AB], EQ 90MG BASE [AB]
  • Manufacturer: STRIDES PHARMA
    Approval date: April 30, 2018
    Strength(s): EQ 30MG BASE [AB], EQ 60MG BASE [AB], EQ 90MG BASE [AB]
  • Manufacturer: SUN PHARM
    Approval date: October 11, 2018
    Strength(s): EQ 30MG BASE [AB], EQ 60MG BASE [AB], EQ 90MG BASE [AB]
  • Manufacturer: WATSON LABS TEVA
    Approval date: December 27, 2018
    Strength(s): EQ 30MG BASE [AB], EQ 60MG BASE [AB], EQ 90MG BASE [AB]

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

  • Rapid dissolution formulation of a calcium receptor-active compound
    Patent 7,829,595
    Issued: November 9, 2010
    Inventor(s): Lawrence; Glen Gary & Alvarez; Francisco J. & Lin; Hung-Ren H. & Ju; Tzuchi R.
    Assignee(s): Amgen Inc.

    The present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of a calcium receptor-active compound and at least one pharmaceutically acceptable excipient, wherein the composition has a controlled dissolution profile. The present invention further relates to a method of manufacturing the pharmaceutical composition, as well as a method of treating a disease using the pharmaceutical composition.

    Patent expiration dates:

    • September 22, 2026
      ✓ 
      Patent use: METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA
      ✓ 
      Drug product
  • Rapid dissolution formulation of a calcium receptor-active compound
    Patent 9,375,405
    Issued: June 28, 2016
    Assignee(s): Amgen, Inc.

    The present invention relates to a pharmaceutical composition comprising a therapeutically effective amount of a calcium receptor-active compound and at least one pharmaceutically acceptable excipient, wherein the composition has a controlled dissolution profile. The present invention further relates to a method of manufacturing the pharmaceutical composition, as well as a method of treating a disease using the pharmaceutical composition.

    Patent expiration dates:

    • September 22, 2026
      ✓ 
      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:

    • May 23, 2020 - CLINICAL INFORMATION ADDED TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE LABELING.
    • November 21, 2021 - TREATMENT OF HYPERCALCEMIA IN ADULT PATIENTS WITH PRIMARY HYPERPARATHYROIDISM FOR WHOM PARATHYROIDECTOMY WOULD BE INDICATED ON THE BASIS OF SERUM CALCIUM LEVELS, BUT WHO ARE UNABLE TO UNDERGO PARATHYROIDECTOMY.

Further information

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

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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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