Foundayo Patent Expiration

Foundayo is a drug owned by Eli Lilly And Co. It is protected by 1 US drug patent filed in 2026 out of which none have expired yet. Foundayo's patents will be open to challenges from 01 April, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 26, 2037. Details of Foundayo's patents and their expiration are given in the table below.

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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
USRE50455 NA
Sep, 2037

(11 years from now)

Active


FDA has granted several exclusivities to Foundayo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Foundayo, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Foundayo.

Exclusivity Information

Foundayo holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Foundayo's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Apr 01, 2031

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US patents provide insights into the exclusivity only within the United States, but Foundayo is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Foundayo's family patents as well as insights into ongoing legal events on those patents.

Foundayo's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Foundayo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 26, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Foundayo Generics:

There are no approved generic versions for Foundayo as of now.





About Foundayo

Foundayo is a drug owned by Eli Lilly And Co. Foundayo uses Orforglipron Calcium as an active ingredient. Foundayo was launched by Eli Lilly in 2026.

Approval Date:

Foundayo was approved by FDA for market use on 01 April, 2026.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Foundayo is 01 April, 2026, its NCE-1 date is estimated to be 01 April, 2030.

Active Ingredient:

Foundayo uses Orforglipron Calcium as the active ingredient. Check out other Drugs and Companies using Orforglipron Calcium ingredient

Dosage:

Foundayo is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 9MG BASE TABLET Prescription ORAL
EQ 2.5MG BASE TABLET Prescription ORAL
EQ 5.5MG BASE TABLET Prescription ORAL
EQ 14.5MG BASE TABLET Prescription ORAL
EQ 0.8MG BASE TABLET Prescription ORAL
EQ 17.2MG BASE TABLET Prescription ORAL