ADDYI Drug Patent Profile

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

Addyi is a drug marketed by Sprout Pharms and is included in one NDA. There is one patent protecting this drug.

This drug has forty-two patent family members in twenty-nine countries.

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

DrugPatentWatch^® Generic Entry Outlook for Addyi

Addyi was eligible for patent challenges on August 18, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 13, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ADDYI

International Patents:	42
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Patent Applications:	803
Drug Prices:	Drug price information for ADDYI
What excipients (inactive ingredients) are in ADDYI?	ADDYI excipients list
DailyMed Link:	ADDYI at DailyMed

See drug prices for ADDYI

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

Constraining patent/regulatory exclusivity:

REVISION TO THE INDICATION TO INCLUDE WOMEN LESS THAN 65 YEARS OF AGE INDEPENDENT OF REPRODUCTIVE STATUS

NDA:

022526

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.

Pharmacology for ADDYI

Mechanism of Action

P-Glycoprotein Inhibitors

US Patents and Regulatory Information for ADDYI

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

This potential generic entry date is based on REVISION TO THE INDICATION TO INCLUDE WOMEN LESS THAN 65 YEARS OF AGE INDEPENDENT OF REPRODUCTIVE STATUS.

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
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015		RX	Yes	Yes
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015		RX	Yes	Yes

Expired US Patents for ADDYI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015

International Patents for ADDYI

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

Country	Patent Number	Title	Estimated Expiration
Argentina	037109	USO DE FLIBANSERINA
Argentina	077480	USO DE FLIBANSERINA
Austria	327757
Australia	2002333894

ADDYI (nifedipine? no) Market Dynamics and Financial Trajectory: Revenue Drivers, Exclusivity Risk, and Competitive Pressure

Last updated: July 30, 2026

What is ADDYI and how is it marketed in the US?

ADDYI is a U.S.-market prescription brand. Its market dynamics are dominated by (1) time-to-generic/biologic entry risk, (2) payor contracting and step-therapy behavior, (3) safety and adherence signals, and (4) competitive launches in the same therapeutic class.

Critical framing for business planning

• Brand uptake typically tracks formulary inclusion and preferred-tier placement more than list-price changes.
• Revenue trajectory is usually split into three phases:
  1. launch ramp tied to detailing and coverage,
  2. plateau under established contracting,
  3. erosion once high-odds-to-launch competitors gain formulary share or trigger switching.

Execution factors that move net sales

• Rebates and discounts are the dominant determinant of net revenue versus gross.
• Coverage decisions by major PBMs set the run-rate for prescriptions and net pricing.
• Limited distribution or REMS-like controls (if applicable) can slow diffusion relative to peers.

How do ADDYI’s market dynamics compare with competing drugs in its class?

ADDYI’s competitive position is driven by therapeutic equivalence, tolerability, and formulary status versus same-class alternatives.

Key comparison axes

• Place-in-therapy: preferred first-line versus later-line positioning.
• Dosing convenience: once-daily versus multiple daily dosing drives switching velocity.
• Adverse event burden: safety events change prescriber willingness to switch back from alternatives.
• Patient support programs: can influence persistence, not just initial fills.

What is the revenue trajectory for ADDYI since launch?

ADDYI’s financial trajectory follows the standard brand arc: ramp, plateau, then pressure. The inflection points depend on:

• new formulary contracts,
• competitive introductions,
• and any label expansions that expand prescriber base.

Revenue drivers that typically explain quarter-to-quarter changes

• Prescription volume growth or decline
• Net price changes from rebate rate shifts
• Channel inventory and wholesaler restocking behavior around competitive entries

Financial metrics to monitor

• Net sales by quarter (relevant to earnings and forecasting models)
• Gross-to-net bridge drivers (rebates, discounts, chargebacks)
• Prescriptions and TRx share (proxy for share of voice and coverage)

When does ADDYI lose exclusivity and face generic launch risk?

Exclusivity exposure is determined by patent expiration and regulatory exclusivities (U.S. 5-year/7-year and 12-year exclusivities where applicable). Once exclusivity approaches, market access and generic readiness become the dominant pressure sources.

What to model for generic entry

• First generic launch date (marketing authorization timing)
• Launch sequencing (authorized generics, settlements)
• Expected net price erosion pattern in the first 6 to 18 months after launch

How exclusivity timelines typically impact revenue

• 18 to 36 months pre-expiration: payors begin contract renegotiations
• 0 to 6 months pre-expiration: manufacturers tighten distribution and inventory planning
• Launch window: rapid rebate adjustment and coverage expansion for generics

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

Patent strength in a brand lifecycle is assessed by: claim scope, remaining life, and litigation posture. For ADDYI, business relevance comes from:

• “block” patents that prevent approval (composition, formulation, or method-of-use),
• “design-around” risk (ability for generics to avoid infringement),
• and whether Orange Book-listed patents align with likely generic formulations.

Estate mapping needed for decision-making

• Composition-of-matter patents: highest barrier, longest commercial control
• Formulation or dosage form patents: moderate barrier, but can be circumvented with alternative pharmaceutics
• Method-of-use patents: contingent on label coverage and generic carve-outs
• Manufacturing/process patents: can matter if generics copy process claims

What is the Orange Book status of ADDYI?

Orange Book status determines FDA-legal risk for generic or biosimilar competition. For a full risk forecast, teams track:

• listed NDA/BLA and associated patent numbers,
• patent expiration dates,
• and which patents are “B” (drug product), “I” (approved method), or “A” (active ingredient).

How Orange Book listings translate into market outcomes

• More listed patents can reduce generic entry odds and increase settlement leverage
• Narrow method-of-use listings can allow “carve-out” labels to launch earlier

What Paragraph IV challenges exist for ADDYI and who filed?

Paragraph IV litigation risk is a primary predictor of launch timing and revenue drop. The market impact depends on:

• number of challengers,
• whether an ANDA is stayed under 30-month stay provisions,
• and settlement versus continued litigation.

Business-useful signals

• First Paragraph IV filing date signals earliest likely challenged approval date.
• Settlement terms reveal practical launch timing even when exclusivity remains.

What ADDYI patent litigation affects revenue and timing of entry?

In the U.S., revenue erosion often follows litigation outcomes because they determine launch calendars.

Key litigation mechanics to model

• Court rulings that invalidate or find noninfringement for specific claims
• Settlements that fix a “design date” for generic entry
• Possible appeals that delay final enforceability

Market effect

• Even without immediate generic entry, legal uncertainty can drive PBM contracting to assume imminent competition.

What formulations are protected by ADDYI and do they limit generic substitutions?

Formulation and dosage form patents can constrain “automatic” substitution if generics must avoid infringing product claims.

Where formulation protection matters most

• Extended-release versus immediate-release differentiation
• Particle size, crystal form, polymorph, or solid-state controls
• Storage stability and dissolution profiles

Substitution risk

• If generics can launch with a non-infringing formulation and still meet therapeutic equivalence standards, substitution accelerates.
• If formulation claims are broad, generic launch can require continued design-around or delay.

How does ADDYI compare with other brands on affordability, contracting, and persistence?

Payor contracting determines net revenue more than list price.

Competitive contracting outcomes

• Preferred tier placement drives higher TRx share.
• Step therapy limits access for naïve patients and can slow switching.

Persistence and adherence

• Patient adherence affects TRx volume stability.
• Safety-related discontinuations shift share to competitors with better tolerability profiles.

Which companies are challenging ADDYI and what are their launch plans?

Challenger identity is a strong predictor of launch execution. Parties with mature ANDA development teams and prior litigation experience typically move faster.

How to evaluate challenger readiness

• Completeness of ANDA dossier (CMC readiness)
• Manufacturing site status and inspection history
• Prior ANDA launches in the same therapeutic class

What is the likely biosimilar risk for ADDYI?

Biosimilar risk is only relevant if ADDYI is a biologic. If ADDYI is not a biologic, biosimilar risk is not applicable as a driver of exclusivity erosion.

What is the commercial landscape for ADDYI: distribution, channels, and pricing?

Brand performance is shaped by channel execution and pricing power.

Commercial mechanisms that can lift or reduce net sales

• Wider distribution increases TRx capture
• PBM rebate structure can improve net pricing but may also invite faster competitor targeting
• Specialty versus retail distribution mix drives throughput and refill patterns

Pricing sensitivity

• Higher patient cost-sharing can suppress adherence and shift demand to alternatives

What financial scenarios should investors or licensors model for ADDYI?

Modeling revenue decline should be calendar-anchored to exclusivity and litigation outcomes, not only to competitor messaging.

Scenario set

1. No meaningful infringement/entry delay: revenue erosion begins at generic entry onset.
2. Settlement with later “design date”: revenue stays elevated longer, then drops sharply.
3. Prolonged litigation: delayed entry but with rising uncertainty that can still pressure net pricing.
4. Label changes or expanded indications: can offset volume loss but may introduce new patent/litigation vectors.

Key Takeaways

• ADDYI’s revenue trajectory is primarily determined by formulary coverage, net pricing dynamics, and the timing of generics or other class competitors.
• Exclusivity timelines and Orange Book-listed patents create the calendar for generic entry risk and market access renegotiations.
• Paragraph IV litigation and settlements typically drive the biggest step-changes in net sales by setting practical launch dates.
• Formulation and method-of-use protections can slow substitution, but their impact depends on claim scope and label carve-outs.
• The strongest forecasting signals are (1) challenger filings, (2) litigation outcomes, and (3) observed PBM contracting shifts ahead of exclusivity expiration.

FAQs

1) How do PBM formulary changes typically affect ADDYI net sales?
Formulary tier movement, step therapy adoption, and rebate re-contracting drive TRx volume and net price shifts.

2) What is the relationship between Paragraph IV filings and generic launch timing for ADDYI?
First Paragraph IV filings indicate the earliest plausible challenge-based entry window, with 30-month stay mechanics and court outcomes determining actual launch timing.

3) How do formulation patents change generic substitution risk for ADDYI?
Product-claim scope and therapeutic equivalence requirements determine whether a generic can launch quickly with a non-infringing formulation.

4) What litigation terms most influence ADDYI’s revenue erosion curve?
Settlement “design-around” dates, carve-outs, and injunction scope dictate whether erosion is gradual or stepwise.

5) How should competitors benchmark ADDYI pricing power?
Benchmarking should focus on net pricing and rebates after contract renewals, not only list price, and track TRx share for proof of access.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. FDA. Drug Development and Drug Interactions: Hatch-Waxman provisions and exclusivity framework.

DrugChatter Q&A for ADDYI

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