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5 Drugs Facing Key Patent Expirations and Potential Generic Entry from December 2021 – February 2022

A challenge in anticipating generic entry is elucidating which patents and regulatory protections constrain generic entry. Yali Friedman at DrugPatentWatch, presents a set of an estimated loss of exclusivity dates for five drugs, from December 2021 through February 2022. These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents and US regulatory protections covering drugs.

Extract:

5 Drugs Facing Key Patent Expirations and Potential Generic Entry from December 2021 – February 2022

A challenge in anticipating generic entry is elucidating which patents and regulatory protections constrain generic entry. Presented here is a set of estimated loss of exclusivity dates for five drugs, from December 2021 through February 2022. These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents and US regulatory protections covering drugs. This methodology can be extended to ex-US jurisdictions by leveraging these estimates and tracking patent family members in other patent offices.

LICART (diclofenac epolamine)

Estimated US Loss of Exclusivity Date: 19 December 20212

Generic Entry Controlled by: FDA Regulatory Exclusivity LICART is marketed by Ibsa Inst Bio and is included in one NDA. By analysing the patents and regulatory protections it appears that the earliest date for generic entry in the US will be December 19th, 2021, when FDA Regulatory Exclusivity expires.

VAZALORE (aspirin)

Estimated US Loss of Exclusivity Date: 19 December 20213

Generic Entry Controlled by: US Patent 9351984

Title: Compositions comprising lecithin oils and NSAIDs for protecting the gastrointestinal tract and providing enhanced therapeutic activity

Abstract: “A novel pharmaceutical composition is provided by which nonsteroidal anti-inflammatory drugs (NSAIDs) are added directly to phospholipid-containing oil such as lecithin oils or to a bio-compatible oil to which a phospholipid has been added to make a NSAID-containing formulation that possess low gastrointestinal (GI) toxicity and enhanced therapeutic activity to treat or prevent inflammation, pain, fever, platelet aggregation, tissue ulcerations and/or other tissue disorders. The composition of the invention is in the form of a non-aqueous solution, paste, suspension, dispersion, colloidal suspension or in the form of an aqueous emulsion or microemulsion for internal, oral, direct or topical administration.”

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