Radius Pharmaceuticals, Inc. and co-plaintiff Ipsen Pharma S.A.S. have secured a decisive legal victory in their patent infringement case against Orbicular Pharmaceutical Technologies Private Ltd., with the U.S. District Court for the District of Massachusetts ruling in favor of the plaintiffs and upholding the validity of all five TYMLOS® (abaloparatide) patents. The latest patent protection will remain in effect through April 30, 2038, providing extended market exclusivity for the osteoporosis treatment.
Court Upholds Patent Portfolio Strength
The lawsuit, filed in September 2022, challenged Orbicular's attempt to seek FDA approval for a generic abaloparatide product. Radius asserted that Orbicular's proposed generic would infringe five patents held by the company. The court's comprehensive ruling validates the entire TYMLOS patent portfolio, reinforcing the intellectual property protection surrounding this bone health therapy.
The favorable decision represents a significant commercial win for Radius, a specialty biopharmaceutical company focused on bone health and related therapeutic areas. The extended patent protection through 2038 provides substantial runway for the company to maintain market exclusivity for their lead osteoporosis treatment.
TYMLOS Treatment Profile
TYMLOS (abaloparatide) injection is a parathyroid hormone related peptide approved by the U.S. Food and Drug Administration for treating postmenopausal women and men with osteoporosis at high risk for fracture. The FDA defines high-risk patients as those with a history of osteoporotic fracture or multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapies.
The medication is supplied as a single-patient multi-use prefilled pen designed for subcutaneous administration of 80 micrograms per dose over a 30-day period. This delivery system provides patients with a convenient self-administration option for their osteoporosis management.
Market Protection and Commercial Impact
The patent victory secures Radius's position in the competitive osteoporosis treatment landscape by preventing generic competition for TYMLOS through the end of the next decade. This extended exclusivity period allows the company to continue building market share and generating revenue from their flagship bone health product without the pricing pressure typically associated with generic entry.
For patients and healthcare providers, the ruling ensures continued availability of TYMLOS as a treatment option for high-risk osteoporosis patients, particularly those who may not respond adequately to or tolerate other available therapies in this therapeutic class.
