- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Allergan confirms generic Tyvaso patent challenge
30 July 2015 • Author: Victoria White
Allergan today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Treprostinil Inhalation Solution, 0.6 mg/mL, 2.9 mL ampules.
Allergan’s ANDA product is a generic version of United Therapeutics Corporation‘s Tyvaso®, which is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability.
United Therapeutics has filed suit against Allergan
United Therapeutics filed suit against Allergan on 22 July 2015 in the US District Court for the District of New Jersey seeking to prevent Allergan from commercialising its ANDA product prior to the expiration of certain US Patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Allergan’s ANDA for up to 30 months from the date the plaintiffs received notice of Allergan’s ANDA filing or until final resolution of the matter before the court, whichever occurs sooner.
Based on available information, Allergan believes it may be a “first applicant” to file an ANDA for the generic version of Tyvaso and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending December 31, 2014, Tyvaso had US sales of approximately $463 million, according to United Therapeutics.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics