Generic entry timeline

Zavesca generics — when can they launch?

Zavesca (MIGLUSTAT) · AstraZeneca · 10 active US patents · 0 expired

Earliest patent expiry

2033-03-07

7 years remaining

Full patent estate to

2038-09-16

complete protection through 2038

FDA approval

2003

AstraZeneca

Where Zavesca sits in the generic timeline

Long-dated protection: earliest active US patent for Zavesca extends to 2033 (~7 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.

Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.

Patent estate by type — active patents

Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.

Method of Use — 10 patents

FDA U-codes carved out by Zavesca patents

Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.

U-code	Description
`U-3726`	(no description)

Sample patent estate

Showing 6 of 10 active US patents. View full estate on the Zavesca drug page →

US10512677 Method of Use · expires 2033-03-07

This patent protects compositions of high-concentration acid alpha-glucosidase with an active site-specific chaperone for treating Pompe disease.

USPTO title: High concentration alpha-glucosidase compositions for the treatment of pompe disease
US12419937 Method of Use · expires 2033-03-07

This patent protects compositions of high concentrations of acid Î±-glucosidase with an active site-specific chaperone for treating Pompe disease.

USPTO title: High concentration alpha-glucosidase compositions for the treatment of Pompe disease
US11278599 Method of Use · expires 2033-03-07

This patent protects compositions of high-concentration acid alpha-glucosidase with an active site-specific chaperone for treating Pompe disease.

USPTO title: High concentration alpha-glucosidase compositions for the treatment of Pompe disease
US10961522 Method of Use · expires 2035-09-30

This patent protects a recombinant human alpha glucosidase composition with a specific glycan composition and methods of its use.

USPTO title: Highly potent acid alpha-glucosidase with enhanced carbohydrates
US10208299 Method of Use · expires 2035-09-30

This patent protects a recombinant human alpha glucosidase composition derived from CHO cells with a specific glycan composition, and methods of its use.

USPTO title: Highly potent acid alpha-glucosidase with enhanced carbohydrates
US11753632 Method of Use · expires 2035-09-30

This patent protects a recombinant human alpha glucosidase composition with a specific glycan composition and methods of its use.

USPTO title: Highly potent acid alpha-glucosidase with enhanced carbohydrates

Sources

FDA Orange Book — patents listed against Zavesca (NDA filed 2003)
Zavesca drug profile — full patent estate, indications, clinical trials, pricing
AstraZeneca patent portfolio
Patent cliff 2033 — every drug losing US exclusivity that year

Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.

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