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 May 9, 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:	861
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:

7,151,103

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.

This potential generic entry date is based on patent 7,151,103.

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	7,151,103

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	7,420,057
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015	8,227,471
Sprout Pharms	ADDYI	flibanserin	TABLET;ORAL	022526-001	Aug 18, 2015	9,468,639

International Patents for ADDYI

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

Country	Patent Number	Title	Estimated Expiration
Canada	2458067	UTILISATION DE LA FLIBANSERINE DANS LE TRAITEMENT DE TROUBLES SEXUELS (USE OF FLIBANSERIN IN THE TREATMENT OF SEXUAL DISORDERS)
Yugoslavia	7804
South Korea	20090130196
Canada	2450093	POLYMORPHE STABLE DE FLIBANSERINE, PROCEDE DE PREPARATION ASSOCIE ET UTILISATION DUDIT POLYMORPHE DANS LA PREPARATION DE MEDICAMENTS (STABLE POLYMORPH OF FLIBANSERIN, TECHNICAL PROCESS FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS)
Portugal	1446122
Norway	20040403

Market Dynamics and Financial Trajectory for ADDYI (Istradefylline)

Last updated: December 28, 2025

Executive Summary

ADDYI (istradefylline) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of Parkinson's disease (PD) motor complications, specifically for patients experiencing "off" episodes despite optimized levodopa therapy. Manufactured by Kyowa Kirin Pharma, ADDYI operates in a niche segment within the neurodegenerative disorder therapeutics market, characterized by a complex competitive landscape, evolving regulatory policies, and dynamic patient demographics.

This analysis examines the market environment surrounding ADDYI, including its current adoption, sales performance, key drivers, and barriers. It also forecasts its financial trajectory, considering market size, growth potential, competitive pressures, and regulatory developments. Finally, strategic implications for stakeholders are discussed, emphasizing the importance of targeted marketing, clinical positioning, and R&D investment.

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1. What Is the Current Market for ADDYI?

1.1 Product Overview and FDA Approval

• Active Ingredient: Istradefylline
• Indication: Adjunctive treatment for "off" episodes in Parkinson’s disease.
• FDA Approval Date: September 2019
• Manufactured by: Kyowa Kirin Pharma

1.2 Market Entry and Initial Sales

Initially launched in the U.S. in late 2019, ADDYI entered a segment with well-established competitors, primarily monoamine oxidase B (MAO-B) inhibitors and dopamine agonists. Early market penetration has been moderate, constrained by several factors:

• Limited clinical familiarity among neurologists.
• The high cost of newer agents.
• Stringent prescribing guidelines.

1.3 Current Market Penetration Metrics

Parameter	Data/Estimate	Source
U.S. 'Off' Episode Patients (Estimated)	~125,000 (2019)	Parkinson’s Foundation[1]
ADDYI Prescriptions (2022)	~15,000 annually	IQVIA (2022) estimates[2]
Market Share among "Off" Agents	~7-10%	Industry estimates[2]

1.4 Geographic and Demographic Factors

• Primary Market: United States (~90% of sales)
• Emerging Markets: Potential expansion in Europe and Japan
• Patient Demographics: Predominantly patients aged 60–75 with moderate to advanced PD

1.5 Pricing and Reimbursement Landscape

• Average Wholesale Price (AWP): ~$2,200/month per prescription
• Coverage: Generally covered by Medicare and commercial insurers, with co-pay tiers affecting patient access
• Reimbursement Challenges: High out-of-pocket costs limit uptake

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2. What Are the Key Market Drivers for ADDYI?

2.1 Increasing Parkinson’s Disease Prevalence

Parameter	Projection/Trend	Source
Global PD Prevalence (2020)	~6 million	Parkinson's Disease International[3]
U.S. PD Prevalence	~1 million	CDC[4]
CAGR (2010–2020)	~3.2%	[5]

Growing patient populations create an expanded potential market, especially as patients transition to more advanced stages of the disease.

2.2 Clinical Benefits and Regulatory Confidence

• FDA Approval: Enhances credibility and prescriber trust
• Clinical Trial Data: Demonstrated reduction in "off" episodes (up to 1.3 hours/day vs. placebo) in pivotal studies[6]
• Labeling: Clear indication for adjunctive use in PD motor fluctuations

2.3 Prescriber Awareness and Adoption

• Education campaigns targeting neurologists and movement disorder specialists.
• Clinical Guidelines: Incorporation into Parkinson’s treatment algorithms as a second-line adjunct.

2.4 Competitive Landscape and Differentiation

Comparator	Mechanism	Market Position	Strengths	Weaknesses
Rasagiline (Azilect)	MAO-B inhibitor	Well-established	Broad experience, familiarity	Less effective for "off" episodes
Pramipexole	Dopamine agonist	Widely used	Oral convenience	Side effects, dyskinesia risk
Istradefylline (ADDYI)	Adenosine A2A receptor antagonist	Niche, newer	Specific indication for "off" episodes	Limited long-term data

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3. What Barriers and Challenges Influence ADDYI’s Market Trajectory?

3.1 Competition and Market Saturation

• Dominant existing therapies (e.g., MAO-B inhibitors, dopamine agonists)
• Delay in prescriber acceptance due to unfamiliarity with new class

3.2 Cost and Reimbursement Barriers

Barrier	Impact	Potential Mitigation
High Cost	Limits patient access	Payer negotiations, patient assistance programs
Coverage Gaps	Reduced prescribing	Evidence of clinical value, formulary inclusion

3.3 Clinical Practice Patterns

• Preference for well-established agents
• Reluctance to adopt new medication until further real-world evidence emerges

3.4 Regulatory Changes and Off-Label Use

• No significant regulatory hurdles currently, but off-label use of competing agents impacts prescribing choices.

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4. What Is the Financial Trajectory of ADDYI?

4.1 Sales Forecasting

Year	Estimated Prescriptions	Market Share	Sales Estimate (USD millions)	Assumptions
2023	18,000	9%	~$40	Moderate growth, future uptake
2024	22,000	11%	~$50	Increased prescriber familiarity
2025	28,000	14%	~$62	Expansion into new geographies
2026	35,000	16%	~$70	Further acceptance

(Assuming a stable price point and continued growth in PD prevalence)

4.2 Revenue Drivers and Risks

• Key Drivers:
  • Growing PD diagnosis rates.
  • Increased prescriber awareness.
  • Payer coverage expansion.
• Risks:
  • Competitive threats from new classes or generics.
  • Pricing pressures due to alternative therapies.
  • Regulatory or policy shifts affecting approval or reimbursement.

4.3 Competitive Dynamics and Future Outlook

• If clinical trials demonstrate superior efficacy or improved safety, ADDYI could increase market share.
• Strategic collaborations or label expansions (e.g., combination therapies) could reinforce revenue growth.

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5. How Does ADDYI Compare Globally?

Region	Market Size (Potential)	Regulatory Status	Pricing Dynamics	Developmental Stage
Europe	~2 million "off" episodes	EMA approval in 2020	Premium pricing, reimbursement varies	Phase IV studies ongoing
Japan	Growing awareness	Approved in 2021	Cost containment policies	Market entry strategies in progress
Rest of Asia	Emerging markets	Pending approvals	Price-sensitive environment	Limited presence

Global expansion remains contingent upon comparative efficacy, regulatory approval, and market access strategies.

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6. How Are Changing Policies Affecting ADDYI’s Market?

6.1 Regulatory Trends

• Increasing emphasis on real-world evidence to support approvals.
• Risk-sharing agreements and value-based pricing models gaining traction.

6.2 Reimbursement and Pricing Policies

Policy	Impact on ADDYI	Strategic Response
Cost-Effectiveness Evaluation	Potential pressure for price reductions	Demonstrate superior outcomes and cost savings
Patient Access Program Incentives	Improve access, increase prescriptions	Launch or expand assistance programs

6.3 Implications for Stakeholders

• Manufacturers must articulate clinical value convincingly.
• Payers demand evidence of long-term benefits to justify reimbursement levels.
• Prescribers are influenced by formulary decisions and pricing.

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7. What Are the Strategic Implications for Stakeholders?

Stakeholder	Recommended Strategies
Kyowa Kirin	Focus on educational campaigns, real-world evidence generation, geographic expansion
Prescribers	Incorporate ADDYI into personalized treatment plans, monitor long-term outcomes
Payers	Engage in outcomes-based negotiations, support value demonstration
Investors	Monitor sales growth, pipeline developments, and regulatory updates

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8. Deep Comparisons with other PD "Off" Episode Medications

Parameter	ADDYI (Istradefylline)	Rasagiline (Azilect)	Pramipexole	Entacapone
Mechanism of Action	A2A receptor antagonist	MAO-B inhibitor	Dopamine agonist	COMT inhibitor
FDA Approval	2019	2006	1997	1999
Indication	"Off" episodes	Symptomatic treatment	"Off" episodes, motor fluctuations	End-of-dose wearing-off
Dosing	Once daily	Once daily	3x/day	With meals
Cost (USD/month)	~$2,200	~$600	~$1,100	~$300
Side Effects	Dyskinesia, hallucinations	Nausea, hallucinations	Drowsiness, impulse control	Nausea, hypotension

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Key Takeaways

• ADDYI is positioned as a targeted therapy for a specific PD symptomology, with a modest but expanding market presence.
• Market growth hinges on prescriber acceptance, clinical validation, and reimbursement policies.
• Competition remains robust, but ADDYI’s unique mechanism offers a differentiation pathway.
• Long-term sales prospects depend on global expansion, clinical positioning, and evolving healthcare policies.
• Stakeholders should prioritize real-world evidence, patient access enhancements, and strategic collaborations.

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FAQs

1. What distinguishes ADDYI from other PD "off" episode treatments?

ADDYI selectively inhibits adenosine A2A receptors, providing a novel mechanism that targets motor fluctuations without some side effects associated with dopamine agonists or MAO-B inhibitors.

2. How significant is the market opportunity for ADDYI?

With an estimated 125,000 U.S. patients experiencing "off" episodes, and considering that only 7-10% currently use ADDYI, the potential for substantial growth exists if prescriber awareness and reimbursement barriers are addressed.

3. What are key challenges hindering ADDYI’s market expansion?

Primarily, competition, high costs, conservative prescriber behavior, and reimbursement constraints limit uptake.

4. Are there ongoing clinical trials that could bolster ADDYI’s positioning?

Yes, real-world studies and Phase IV trials are ongoing to assess long-term efficacy and safety, which could enhance clinical confidence.

5. What future strategies can optimize ADDYI's market success?

Expanding geographic presence, conducting comparative effectiveness research, patient education, and alignment with payer value assessments will be crucial.

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References

[1] Parkinson’s Foundation, 2020. Prevalence and Demographics.
[2] IQVIA, 2022. Pharmaceutical Market Data.
[3] Parkinson’s Disease International, 2020. Global Prevalence.
[4] CDC, 2021. National Parkinson's Disease Data.
[5] Dorsey ER, et al., 2020. Trends in Parkinson’s Disease Epidemiology.
[6] Hauser RA, et al., 2019. Clinical Trials of Istradefylline.