FOUNDAYO Drug Patent Profile

Which patents cover Foundayo, and when can generic versions of Foundayo launch?

Foundayo is a drug marketed by Eli Lilly And Co and is included in one NDA. There is one patent protecting this drug.

This drug has sixty-four patent family members in thirty-nine countries.

The generic ingredient in FOUNDAYO is orforglipron calcium. One supplier is listed for this compound. Additional details are available on the orforglipron calcium profile page.

DrugPatentWatch^® Generic Entry Outlook for Foundayo

Foundayo will be eligible for patent challenges on April 1, 2030. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 1, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FOUNDAYO

International Patents:	64
US Patents:	1
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for FOUNDAYO

FOUNDAYO is protected by one US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eli Lilly And Co	FOUNDAYO	orforglipron calcium	TABLET;ORAL	220934-001	Apr 1, 2026		RX	Yes	No	RE50455		Y	Y
Eli Lilly And Co	FOUNDAYO	orforglipron calcium	TABLET;ORAL	220934-004	Apr 1, 2026		RX	Yes	No	RE50455		Y	Y
Eli Lilly And Co	FOUNDAYO	orforglipron calcium	TABLET;ORAL	220934-002	Apr 1, 2026		RX	Yes	No
Eli Lilly And Co	FOUNDAYO	orforglipron calcium	TABLET;ORAL	220934-006	Apr 1, 2026		RX	Yes	Yes
Eli Lilly And Co	FOUNDAYO	orforglipron calcium	TABLET;ORAL	220934-004	Apr 1, 2026		RX	Yes	No

International Patents for FOUNDAYO

See the table below for patents covering FOUNDAYO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2017330733
Australia	2020223687
Australia	2022205222
Australia	2024201884
Australia	2026202206

Last updated: June 7, 2026

Foundayo (drug) investment scenario and fundamentals analysis: IP, FDA status, commercial runway, and key downside risks

What is Foundayo and what therapeutic market does it target?

Foundayo: Insufficient public, verifiable drug identity details (active ingredient, dosage form, indication, NDA/BLA/RLD, or manufacturer) are provided to map the product to a specific regulatory and patent estate. Without the exact product definition, no accurate market sizing, exclusivity timeline, Orange Book/Biologics License Application status, or litigation landscape can be produced.

What patents protect Foundayo and how strong is the patent estate?

No patent-protecting information for Foundayo can be determined because the drug’s active ingredient, molecular entity, and formulation are not specified.

When does Foundayo lose exclusivity? What are the expected generic and biosimilar entry windows?

Exclusivity requires identifying the reference product in the US system (Orange Book for small molecules, Purple Book for biologics) and the regulatory milestones (NDA approval date, 5-year/3-year exclusivity triggers, pediatric exclusivity, orphan exclusivity if applicable). Foundayo’s regulatory identity is not specified, so exclusivity windows cannot be calculated.

What is the Orange Book status of Foundayo?

No Orange Book status can be provided without the RLD name and active ingredient(s).

What is the FDA regulatory status of Foundayo (NDA vs BLA, pathway, approval history)?

No FDA regulatory status can be established without the product’s NDA/BLA number, applicant, approval date, and route of administration.

How many patents cover Foundayo formulations, methods of use, and manufacturing?

Patent-family counts and claim coverage depend on the specific listed patents and their scope by jurisdiction and claim type (composition, formulation, method-of-use, process). Foundayo’s patent listing details are not provided.

Which companies are challenging Foundayo with Paragraph IV certifications?

Paragraph IV analysis requires the ANDA filers, certification types, and the NDA reference listed drug. None of these inputs are available for Foundayo as stated.

What patent litigation affects Foundayo and what settlement terms changed generic timing?

Litigation timing depends on case captions, district courts, complaint dates, stay expirations, and any settlement triggers tied to FDA effective launch dates. No litigation records can be mapped to Foundayo without a specific RLD identity.

What generic entry risks exist for Foundayo?

Generic entry risk requires:

• Orange Book listed patents and their expiration dates
• Likely Paragraph IV targets
• Expected FDA review timing (priority vs standard), label carve-outs, and whether a design-around is feasible
  No RLD identity is available for Foundayo.

How does Foundayo compare with competing drugs in its therapeutic class?

Comparative fundamentals require knowing the indication, line of therapy, and clinical positioning. Foundayo’s target disease and mechanism are not specified.

Commercial fundamentals for Foundayo: revenue exposure, pricing power, and payer dynamics

A fundamentals model needs:

• US and ex-US net sales (or at least launch year and payer uptake indicators)
• Acquisition cost and gross-to-net structure
• Contract pricing and formulary status
  No Foundayo sales, geography, or payer information is provided.

What would an investor underwrite for Foundayo: base case vs downside case?

Without a mapped product identity, there is no defensible underwriting model for:

• exclusivity-driven revenue durability
• generic/biosimilar risk profile
• litigation duration and settlement probability
• regulatory timing risks
  No product-level inputs are available.

Key dataset table (needed to price exclusivity, litigation risk, and entry timing)

Required field	Status for Foundayo (as provided)
Active ingredient / INN	Not provided
Dosage form and route	Not provided
Indication	Not provided
US RLD name	Not provided
NDA/BLA number	Not provided
Approval date	Not provided
Applicant/MAH	Not provided
Orange Book patents (number, types)	Not provided
Patent expiration dates	Not provided
Exclusivity type(s) (5/3/Orphan/Pediatric)	Not provided
ANDA/BLA challengers	Not provided
Litigation docket entries	Not provided
US net sales / trajectory	Not provided
Pricing and payer coverage	Not provided

Key Takeaways

• No investment-grade analysis can be completed for Foundayo without the drug’s specific regulatory identity (active ingredient, RLD name/NDA or BLA number, indication, and manufacturer).
• Patent and exclusivity modeling, Paragraph IV risk, litigation impact, and commercial underwriting all require product-level mapping to the US regulatory record.

FAQs

1. What documents determine Foundayo exclusivity in the US?
2. How do Paragraph IV certifications affect launch timing for drugs like Foundayo?
3. What patent claim types most often block generic entry to small-molecule products like Foundayo?
4. How is biosimilar risk assessed when the reference product is a biologic like Foundayo?
5. What underwriting metrics best predict long-term cash flows for branded products facing generic competition?

References

No sources were cited because Foundayo’s specific product identity and corresponding FDA/patent/regulatory records were not available in the prompt.