Generic Tymlos Availability
Last updated on Jan 8, 2025.
Tymlos is a brand name of abaloparatide, approved by the FDA in the following formulation(s):
TYMLOS (abaloparatide - solution;subcutaneous)
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Manufacturer: RADIUS
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 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.
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Abaloparatide formulations and methods of testing, storing, modifying, and using same
Patent 10,996,208
Issued: May 4, 2021
Inventor(s): Williams Greg & Palwai Naveen & Hanley David
Assignee(s): Radius Health, Inc.Provided herein are newly discovered methods of analyzing abaloparatide samples for abaloparatide isomers. Additionally, methods of storing and treating with abaloparatide in view of the newly discovered abaloparatide isomers are described.
Patent expiration dates:
- April 30, 2038✓
- April 30, 2038
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Methods for detecting neutralizing antibodies to parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHRP) analog
Patent 11,255,842
Issued: February 22, 2022
Inventor(s): Chandler Heidi K.
Assignee(s): Radius Health, Inc.The present disclosure is directed to methods (e.g., in vitro methods) for detecting the presence of neutralizing antibodies to PTH or PTHrP analog in a sample. The in vitro method comprises the steps of obtaining a sample from a subject; contacting the sample with a cell; measuring cyclic adenosine monophosphate (cAMP) levels; and detecting the presence of neutralizing antibodies when cAMP levels are reduced relative to a negative control sample without neutralizing antibodies. An in vitro method of detecting the presence of neutralizing antibodies in a sample from a subject treated with Abaloparatide, is also provided. Further provided herein is a kit for carrying out the methods described herein comprising components required to carry out the obtaining, contacting, measuring and detecting steps and instructions for use.
Patent expiration dates:
- January 10, 2040✓
- January 10, 2040
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Patent 11,680,942
Patent expiration dates:
- January 10, 2040✓
- January 10, 2040
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Patent 11,782,041
Patent expiration dates:
- April 30, 2038✓✓
- April 30, 2038✓✓
- April 30, 2038
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Patent 11,977,067
Patent expiration dates:
- April 30, 2038✓
- April 30, 2038
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Patent 7,803,770
Patent expiration dates:
- April 28, 2031✓
- April 28, 2031
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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. RichardThe 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✓
- November 8, 2027
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Method of drug delivery for bone anabolic protein
Patent 8,748,382
Issued: June 10, 2014
Inventor(s): Dey Michael J. & Mondoly Nathalie & Rigaud Benedicte & Henderson Bart & Lyttle C. RichardThe 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✓
- October 3, 2027✓
- October 3, 2027
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Patent RE49444
Patent expiration dates:
- April 28, 2031✓
- April 28, 2031✓
- April 28, 2031
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:
- September 20, 2024 - INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION
- December 19, 2025 - TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE (DEFINED AS A HISTORY OF OSTEOPOROTIC FRACTURE OR MULTIPLE RISK FACTORS FOR FRACTURE), OR PATIENTS WHO HAVE FAILED OR ARE INTOLERANT TO OTHER AVAILABLE OSTEOPOROSIS THERAPY
More about Tymlos (abaloparatide)
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- FDA approval history
- Drug class: parathyroid hormone and analogs
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Glossary
Term | Definition |
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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.