Generic entry timeline

Tymlos generics — when can they launch?

Tymlos (ABALOPARATIDE) · Radius · 9 active US patents · 0 expired

Earliest patent expiry

2027-10-03

1 year remaining

Full patent estate to

2040-01-10

complete protection through 2040

FDA approval

2017

Radius

Where Tymlos sits in the generic timeline

Imminent generic cliff: earliest active US patent for Tymlos expires in 2027 (~1 year from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.

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 — 6 patents
Formulation — 3 patents

FDA U-codes carved out by Tymlos 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-3543`	(no description)
`U-2009`	(no description)
`U-3322`	(no description)

Sample patent estate

Showing 6 of 9 active US patents. View full estate on the Tymlos drug page →

US8748382 Method of Use · expires 2027-10-03

This patent protects a storage-stable composition containing a parathyroid hormone-related protein (PTHrP) for treating osteoporosis or increasing bone mass or quality.

USPTO title: Method of drug delivery for bone anabolic protein
US8148333 Formulation · expires 2027-11-08

This patent protects a stable composition containing a parathyroid hormone-related protein (PTHrP) analogue for treating osteoporosis or increasing bone mass or quality.

USPTO title: Stable composition comprising a PTHrP analogue
US7803770 Method of Use · expires 2031-04-28

This patent protects a storage-stable composition containing a parathyroid hormone-related protein (PTHrP) for treating osteoporosis.

USPTO title: Method of treating osteoporosis comprising administration of PTHrP analog
USRE49444 Method of Use · expires 2031-04-28

This patent, US RE49444, protects a specific method of using the drug Tymlos.
US11977067 Formulation · expires 2038-04-30

This patent protects methods of analyzing, storing, and using abaloparatide, specifically in relation to its isomers.

USPTO title: Abaloparatide formulations and methods of testing, storing, modifying, and using same
US11782041 Method of Use · expires 2038-04-30

This patent protects methods of analyzing, storing, and using abaloparatide, specifically in relation to its newly discovered isomers.

USPTO title: Abaloparatide formulations and methods of testing, storing, modifying, and using same

Sources

FDA Orange Book — patents listed against Tymlos (NDA filed 2017)
Tymlos drug profile — full patent estate, indications, clinical trials, pricing
Radius patent portfolio
Patent cliff 2027 — 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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