FOUNDAYO Drug Patent Profile

Which patents cover Foundayo, and what generic alternatives are available?

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
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for FOUNDAYO
What excipients (inactive ingredients) are in FOUNDAYO?	FOUNDAYO excipients list
DailyMed Link:	FOUNDAYO at DailyMed

See drug prices for FOUNDAYO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FOUNDAYO

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

220934

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

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

Last updated: June 6, 2026

Foundayo drug market dynamics and financial trajectory (revenue, exclusivity, and generic/biosimilar risk)

Foundayo is not identifiable with sufficient specificity to support a market and financial trajectory analysis. No drug-level market data, FDA product record, or patent estate linkage can be produced for “FOUNDAYO” as written.

What is Foundayo’s FDA status and what Orange Book listings govern sales?

No FDA product record or Orange Book listing can be mapped to “FOUNDAYO” in the provided prompt context, so product launch timing, exclusivity end dates, and listed patents cannot be stated.

Which applicant and NDA/BLA does Foundayo correspond to?

No NDA/BLA identity can be determined for “FOUNDAYO,” so applicant, approval date, labeling, and pathway (505(b)(2), 505(j), BLA, etc.) cannot be tied to a concrete regulatory trail.

What exclusivity protects Foundayo and when does exclusivity end?

Exclusivity cannot be assigned without the correct product identity (including application number and dosage form).

When does Foundayo lose exclusivity and what generic entry risks exist?

No product-specific patent or exclusivity timeline can be constructed without mapping “FOUNDAYO” to its correct active ingredient, dosage form, and FDA application.

Do Paragraph IV challenges exist for Foundayo?

Paragraph IV status cannot be determined because no Orange Book-cited drug/patent list or FDA “Patent Dispute” record can be tied to the string “FOUNDAYO.”

What is the likelihood of a generic launch after first exclusivity expiration?

A generic launch risk assessment requires at minimum: listed formulation and method-of-use patents, earliest effective patent expiration, and settlement/consent order terms. None can be derived from “FOUNDAYO” as provided.

How strong is the patent estate for Foundayo and what patents protect key formulations?

A patent strength analysis requires the correct patent family set (independent composition claims, salt forms, polymorphs, formulations, manufacturing, and method-of-use). “FOUNDAYO” cannot be mapped to a patent portfolio in this prompt context, so no patent numbers, assignees, filing dates, or expiration dates can be stated.

Which companies own or challenge Foundayo’s patents?

No assignees or challengers can be identified without the product and patent linkage.

What method-of-use or dosing regimen claims affect exclusivity?

Method-of-use protection cannot be evaluated without identifying the relevant claims and jurisdictions.

What litigation, settlements, and regulatory disputes affect Foundayo’s revenue curve?

No litigation docket, settlement agreement, or FDA dispute timeline can be produced without mapping the correct drug and reference listing to court filings or FDA records.

Has Foundayo been subject to patent infringement suits?

No suit identifiers can be provided because the underlying drug is not identifiable.

Were there Hatch-Waxman settlements tied to Foundayo?

Settlement terms cannot be stated without the product’s ANDA dispute history.

What are the key market dynamics for Foundayo: payer mix, pricing, and competitive intensity?

Market dynamics analysis depends on the active ingredient, strength, route, indication, and target population. None can be determined from “FOUNDAYO” alone, so pricing trajectory, reimbursement pressure, and competitive switching dynamics cannot be anchored to a factual market record.

What competitors pressure Foundayo’s share: brands, generics, or biosimilars?

No competitor set can be formed without knowing the indication and therapeutic class tied to Foundayo.

How does Foundayo price evolve versus therapeutic alternatives?

No pricing inputs can be connected to the product identity.

Foundayo financial trajectory: revenue drivers, spend profile, and scaling milestones

A revenue trajectory requires at least one verifiable anchor such as: post-approval sales trend, quarterly revenue, prescription volume, net price, market share, or analyst/filing disclosures. None can be retrieved or confirmed for “FOUNDAYO” as written.

What are the main revenue drivers and KPIs for Foundayo?

Without product identity and indication, KPIs cannot be defined for Foundayo.

What manufacturing scale or supply constraints affect Foundayo’s sales?

Supply and manufacturing IP barriers cannot be evaluated without knowing the drug’s manufacturing process and any constrained intermediates or controls.

How does Foundayo compare with similar drugs in the same class?

Comparative positioning requires the exact therapeutic class and mechanism of action. No comparison set can be built for “FOUNDAYO” as provided.

Are there lifecycle-extension strategies (new formulations, line extensions) tied to Foundayo?

Lifecycle-extension risk cannot be stated without identifying patent families and any supplemental NDA/variation history.

Geographic and payer risk: where Foundayo sells and where generics/biosimilars threaten first

Geographic risk mapping requires the regions where Foundayo is marketed and the jurisdiction-specific patent and regulatory status. None can be produced from “FOUNDAYO” as written.

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Key Takeaways

• “FOUNDAYO” cannot be mapped to a specific FDA product record, active ingredient, or patent estate based on the information provided in the prompt.
• Without drug identity, FDA status, exclusivity window, Orange Book listings, Paragraph IV challenges, litigation outcomes, and revenue trajectory cannot be stated with required specificity.

FAQs

1. What FDA application and active ingredient underlie the product name “Foundayo”?
2. Where can the Orange Book patent list for Foundayo be found by drug name?
3. What are the earliest possible patent expiration and exclusivity end dates for Foundayo once identified?
4. What is the Paragraph IV/ANDA litigation status pattern for Hatch-Waxman challenges similar to Foundayo’s profile?
5. Which therapeutic competitors typically drive share loss for new-brand products in the same mechanism class as Foundayo once the drug is identified?

References

(No citable sources can be listed because no drug identity matching “FOUNDAYO” is established from the prompt.)

DrugChatter Q&A for FOUNDAYO

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