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Generic Tymlos Availability

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

TYMLOS (abaloparatide - solution;subcutaneous)

  • Manufacturer: RADIUS HEALTH INC
    Approval date: April 28, 2017
    Strength(s): 3.12MG/1.56ML (2MG/ML) [RLD]

Has a generic version of Tymlos been approved?

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

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

  • Method of treating osteoporosis comprising administration of PTHrP analog
    Patent 7,803,770
    Issued: September 28, 2010
    Inventor(s): Dey; Michael J. & Mondoly; Nathalie & Rigaud; Benedicte & Henderson; Bart & Lyttle; C. Richard
    Assignee(s): Radius Health, Inc. Ipsen Pharma S.A.S.
    The present invention provides a storage-stable composition containing a parathyroid hormone-related protein (PTHrP) and methods of using a PTHrP and the PTHrP compositions described herein to treat osteoporosis, to increase bone mass or to increase bone quality. The composition is storage stable, in sterile form, and in general may be stored at room temperature for at least several weeks to allow convenient parenteral administration to human patients.
    Patent expiration dates:
    • March 26, 2028
      ✓ 
      Patent use: METHOD OF TREATING POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE.
  • Stable composition comprising a PTHrP analogue
    Patent 8,148,333
    Issued: April 3, 2012
    Inventor(s): Dey; Michael J. & Mondoly; Nathalie & Rigaud; Benedicte & Henderson; Bart & Lyttle; C. Richard
    Assignee(s): Radius Health, Inc. Ipsen Pharma S.A.S.
    The present invention provides a storage-stable composition containing a parathyroid hormone-related protein (PTHrP) analogue and methods of using a PTHrP analogue and the PTHrP compositions described herein to treat osteoporosis, to increase bone mass or to increase bone quality. The composition is storage stable, in sterile form, and in general may be stored at room temperature for at least several weeks to allow convenient parenteral administration to human patients.
    Patent expiration dates:
    • November 8, 2027
      ✓ 
      Drug product
  • Method of drug delivery for bone anabolic protein
    Patent 8,748,382
    Issued: June 10, 2014
    Assignee(s): Radius Health, Inc. Ipsen Pharma S.A.S.
    The present invention provides a storage-stable composition containing a parathyroid hormone-related protein (PTHrP) and methods of using a PTHrP and the PTHrP compositions described herein to treat osteoporosis, to increase bone mass or to increase bone quality. The composition is storage stable, in sterile form, and in general may be stored at room temperature for at least several weeks to allow convenient parenteral administration to human patients.
    Patent expiration dates:
    • October 3, 2027
      ✓ 
      Patent use: METHOD OF TREATING POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE.

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:
    • April 28, 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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