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See the DrugPatentWatch profile for Teduglutide
Patent expiry for teduglutide is region- and patent-type specific. In short: - What to distinguish: - Composition-of-matter/patent on the active molecule (teduglutide) - Patents on formulations, delivery, or specific therapeutic uses - Regulatory data exclusivity (biologic) that blocks biosimilars even after patents expire - United States - The core composition patents for teduglutide have generally expired or are expiring around the 2010s–early 2020s. There may be remaining patents on specific formulations or uses in some cases, depending on the jurisdiction and patent family. - As a biologic, teduglutide is protected by regulatory data exclusivity under the BPCIA: 12 years from first approval (Gattex approved in 2012), with a possible 6-month pediatric exclusivity extension. In practice, this can delay biosimilar marketing until roughly 2024–2025, subject to any extensions. - Note: Actual dates can vary by patent family and any pediatric or supplementary protection certificates. - European Union - Data/market exclusivity for biologics is different from the US. EU data protection for a new biologic is typically around 10 years, with potential for extensions (e.g., for pediatric data). Patent expiry for the core molecule and any regional patents varies, but many core patents have already expired or are expiring in the 2020s, while some regional formulation/use patents might extend protection in certain markets. - Exact expiry depends on the country and the specific patent families. - Other regions - Expiry timelines vary similarly by patent family and local regulatory data exclusivity rules. Some regions may have longer or shorter data exclusivity periods. What you might want to do for precise dates - Tell me the country/region you care about (US, EU, UK, Japan, etc.) and whether you’re asking about: - active ingredient (composition) patents - formulation or delivery patents - method-of-use patents - regulatory data exclusivity - I can then point you to specific patent family numbers and the expected expiry dates, and provide up-to-date sources (USPTO/EPO/EMA databases, Google Patents, FDA exclusivity pages). Would you like me to pull country-specific expiry estimates and patent family numbers for teduglutide (US and EU as a start)?
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