Generic semaglutide and Trinidad and Tobago: patents and approval

What the Ministry said, and what it left open

On 29 January 2025, after online Ozempic sales were referred to the police, the Ministry of Health of Trinidad and Tobago issued a clarification¹². It said there are no bureaucratic delays ("red tape") preventing the approval of Ozempic or any other drug, that there was no application from Novo Nordisk's local registered distributor to register it, and that an application for a generic version had been received¹. It added that it was in contact with the Intellectual Property Office, the manufacturer and the local distributor, Alstons Marketing Company Limited, to determine whether a patent for Ozempic exists in Trinidad and Tobago¹. In May 2024 the Ministry's Permanent Secretary, Asif Ali, had told a parliamentary committee: "We don't have an application in (for Ozempic) right now"³.

We found no public statement since then reporting the outcome of the generic application or of the patent check. In February 2026 the CFDD warned about falsified Wegovy tablets, a product "not authorised for use in Trinidad and Tobago"¹⁵.

The patent question

Trinidad and Tobago's Patents Act, 1996 (Act No. 21 of 1996) gives a patent "until the end of the period of twenty years beginning with the date of filing" (section 29)⁴. It allows a non-voluntary licence when "a market for the patented invention is not being supplied" and the applicant has failed to obtain a licence on reasonable commercial terms, no earlier than three years from grant or four from filing (section 46), and lets the Minister authorise government use in the public interest, with compensation (section 48)⁴. Whether a semaglutide patent was ever filed locally is exactly what the Ministry said it was checking¹. A 2026 analysis in Obesity found that 12 countries with 2026 patent expiry account for 47 % of global obesity, and that no patent filings were identified in 150 additional countries, so generic injectable semaglutide could be available in 162 countries by the end of 2026⁹.

Where generics arrived first

India went first. Business Today reported that semaglutide's core patents expired in March 2026, that dozens of domestic companies launched lower-priced versions, and that Novo Nordisk cut starting-dose prices by 36 % for the diabetes product and 48 % for Wegovy⁷. A phase 3 trial in 320 Indian adults with type 2 diabetes found a generic semaglutide non-inferior to the innovator for HbA1c reduction at 24 weeks (mean -2.20 %), with comparable safety¹¹.

Canada followed. Dr Reddy's received a Health Canada Notice of Compliance on 28 April 2026 for a generic semaglutide injection for type 2 diabetes and called Canada the first G7 country to authorise one⁶. Harvard researchers writing in Health Policy said the approval came 114 days after the brand's market exclusivity expired and 26 months after the first generic company filed; the delay arose because Health Canada "had never set out how a manufacturer should establish that a fully synthetic semaglutide is the same drug as a semisynthetic reference product"⁸.

Why a peptide generic is a hard case for the CFDD

The Chemistry, Food and Drugs Division (CFDD) registers drugs by relying on prior approval elsewhere. Its 2022 notice to importers asks for Certificates of Pharmaceutical Product from stringent authorities (EMA, US FDA, Health Canada, Swissmedic, Medsafe, TGA, MHRA) for "biologics and large molecules", and accepts PAHO level 4 regulators and European Union states "For ONLY small molecule and chemical drugs including generics"⁵. It asks for bioequivalence studies for generics and comparability studies for biosimilars, "where applicable", and charges TT$750 per drug⁵. A synthetic semaglutide sits between those boxes: it is a generic, but of a large, modified peptide originally made by recombinant DNA technology. Analytical work now exists to show sameness: a 2025 study used high-resolution mass spectrometry peptide mapping to compare synthetic and recombinant semaglutide and liraglutide, including the fatty-acid modification site¹⁰. With Health Canada now on record, a Canadian certificate for a generic would come from a body on the CFDD's stringent list⁵⁶.

The notice also states: "stability data for our climate falls under Zone IVb", the hot and very humid climate category⁵. For peptides that is not a formality. A 2026 study of solid-state semaglutide found temperature to be a critical factor, with temperature-dependent degradation and impurity formation and loss of the native helical structure at high temperatures¹².

Why it matters clinically

The molecule's evidence is strong: in STEP 1, adults with overweight or obesity lost 14.9 % of body weight on weekly semaglutide versus 2.4 % on placebo¹³, and in SELECT semaglutide cut major cardiovascular events by 20 % (hazard ratio 0.80) in people with established cardiovascular disease and overweight or obesity but no diabetes¹⁴. In Trinidad and Tobago, 61.2 % of adults are overweight or obese (STEPS 2024)¹⁶. Without a registered product, the visible channel is the informal one: the social media sales the Ministry referred to the police in 2025². A registered generic would give physicians a legal product to prescribe¹⁵.