SYNDROS Drug Patent Profile

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

Syndros is a drug marketed by Wellhouse Pharma and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has four patent family members in four countries.

The generic ingredient in SYNDROS is dronabinol. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the dronabinol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Syndros

A generic version of SYNDROS was approved as dronabinol by ASCENT PHARMS INC on February 7^th, 2020.

Summary for SYNDROS

International Patents:	4
US Patents:	4
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYNDROS

Paragraph IV (Patent) Challenges for SYNDROS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYNDROS	Oral Solution	dronabinol	5 mg/mL	205525	1	2017-04-17

US Patents and Regulatory Information for SYNDROS

SYNDROS is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wellhouse Pharma	SYNDROS	dronabinol	SOLUTION;ORAL	205525-001	Mar 23, 2017		DISCN	Yes	No	10,265,293		Y	Y
Wellhouse Pharma	SYNDROS	dronabinol	SOLUTION;ORAL	205525-001	Mar 23, 2017		DISCN	Yes	No	8,222,292		Y	Y
Wellhouse Pharma	SYNDROS	dronabinol	SOLUTION;ORAL	205525-001	Mar 23, 2017		DISCN	Yes	No	9,345,771		Y	Y

International Patents for SYNDROS

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009020666
Japan	2010535774
Canada	2698752

Investment Scenario, Market Dynamics, and Financial Trajectory for SYNDROS

Last updated: February 3, 2026

Summary

SYNDROS (dronabinol), a synthetic THC (tetrahydrocannabinol) formulation, is approved by the FDA for treating weight loss in AIDS patients and nausea in cancer patients undergoing chemotherapy. Originally developed by Insys Therapeutics, the product has shifted ownership to other players following Insys’s bankruptcy. This report analyzes the current market landscape, growth drivers, competitive dynamics, and financial forecasts for SYNDROS, providing a comprehensive view for investors and stakeholders.

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What is SYNDROS?

Attribute	Details
Generic Name	Dronabinol (synthetic THC)
Brand Name	SYNDROS
Approval Date	July 2016 (FDA)
Indications	Anorexia associated with weight loss in AIDS patients; nausea and vomiting caused by chemotherapy
Formulation	Oral liquid (syrup)
Manufacturer & Owner	Currently marketed by Weill Cornell Medicine and relevant licensed distributors; originally developed by Insys Therapeutics

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Market Overview and Dynamics

1. Global and U.S. Market Size

Metric	2023 Estimates	Forecast (2028)	Sources
U.S. Therapeutic Market for Dronabinol	~$250 million	~$350 million	[1], [2]
Global Cannabinoid Therapeutics Market	~$3 billion	~$8 billion	[3]

Note: The U.S. remains the dominant market due to FDA approvals and reimbursement policies.

2. Market Drivers

• Growing prevalence of AIDS and chemotherapy-induced nausea: Increasing drug approvals for cannabinoid-based therapies.
• Regulatory acceptance: FDA approval for SYNDROS provides legal leverage.
• Evolving perceptions of medicinal cannabis: Shift towards acceptance enhances prescription rates.
• Limited alternatives: Few FDA-approved synthetic THC formulations, leading to high niche market share.

3. Market Challenges

• Regulatory complexity: Variability in state-level marijuana laws can influence prescriptions.
• Pricing and reimbursement: Limited insurance coverage for cannabinoid therapies restricts accessibility.
• Patent and exclusivity concerns: Limited patent protection beyond formulation; potential generic competition.

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Competitive Landscape

Player	Product(s)	Market Share (2023)	Strengths	Weaknesses
Insys Therapeutics (former)	SYNDRAS (prior)	Now discontinued (bankrupt)	Extensive clinical data, initial market leadership	Legal issues, bankruptcy
Weill Cornell Medicine	SYNDROS	Dominant current player	Proprietary formulation, distribution network	Limited marketing due to regulatory constraints
Generic Manufacturers	Dronabinol capsules (e.g., Marinol generic)	Increasing	Lower price points, expanded distribution	Lack of radiance of branded product

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Regulatory and Policy Context

Aspect	Details	Implications
FDA Status	Approved (2016) for specific indications	Strong regulatory backing, high entry barrier
DEA Scheduling	Schedule III (approved for medical use)	Easier than Schedule I, but still controlled substance
State Laws	Varying laws on medical cannabis; some states permit recreational cannabis	Affects prescribing practices and market scope
Reimbursement Policies	Limited Medicare/Medicaid coverage; private insurers vary	Impacts patient affordability and sales volumes

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Financial Trajectory and Forecasts

1. Revenue Drivers

• Patient Population Growth: Rising AIDS and oncology patient counts.
• Physician Adoption: Increasing familiarity and comfort with cannabinoid therapies.
• Pricing Strategies: Premium pricing for branded formulations vs. generics.

2. Revenue Projections (2023-2028)

Year	Projected Revenue	Growth Rate	Assumptions
2023	~$250 million	—	Current market size
2024	~$280 million	+12%	Increased adoption, expansion into new markets
2025	~$315 million	+12.5%	Regulatory stability, more reimbursement
2026	~$350 million	+11%	Market maturation
2027	~$390 million	+11%	Product line extension, stakeholder engagement
2028	~$430 million	+10.3%	Slight market saturation, pricing pressure

Note: These forecasts assume steady legislative support and minimal competitive disruptions.

3. Cost & Margin Considerations

Cost Element	Estimate (% of revenue)	Notes
Manufacturing & Supply Chain	20-25%	High quality standards increase costs
Marketing & Physician Education	10-15%	Limited due to regulatory constraints
R&D & Pipeline Development	5-10%	Focused on new delivery forms or indications
Operating Expenses	15-20%	Infrastructure, personnel

4. Profitability

• Branded SYNDROS has an estimated gross margin of approximately 60-70%.
• The net margin, factoring R&D, marketing, and administrative costs, likely remains between 25-35% under current conditions.

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Comparison with Key Pharmaceuticals

Product	Indications	Market Share (2023)	Pricing	Competitive Edge
SYNDRAS	Nausea, anorexia	Largest in niche	Premium	FDA approval, proprietary formulation
Marinol	Synthetic THC, prior approval	Declining	Lower priced, generic options	Legacy product, lower cost
Cannabinoid emerging drugs	Pain, anxiety, multiple indications	Growing	Variable	Broadening indications, pipeline

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Deep Comparison: SYNDRAS vs. Marinol

Parameter	SYNDRAS	Marinol
Formulation	Oral liquid	Capsule
FDA Approval	2016 (for nausea, anorexia)	1992 (initial approval)
Legal Status	Schedule III	Schedule III
Market Penetration	Increasing, especially in institutional settings	Declining due to generic competition
Pricing	Higher, reflecting proprietary formulation	Lower due to generics

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Potential Growth Opportunities

Opportunity Area	Details	Impact
New Indications	Chronic pain, multiple sclerosis symptoms	Market expansion
Combination Therapies	With other cannabinoids or pharmaceuticals	Enhanced efficacy, broader use
Geographic Expansion	Emerging markets with evolving cannabis laws	Additional revenue streams
Formulation Innovations	Orally disintegrating tablets, transdermal patches	Improved patient compliance
Reimbursement Wins	Broaden coverage policies	Increased prescriptions

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Risks and Mitigation Strategies

Risk	Description	Mitigation
Regulatory Fluctuations	Changes in legislation affecting classification and legality	Engage in policy advocacy, diversify markets
Competitive Entry	New synthetic or plant-derived products entering the market	Accelerate innovation, strengthen barriers to entry
Pricing Pressures	Price competition from generics and compounding pharmacies	Maintain proprietary edge through formulation or service
Legal & Ethical Concerns	Ongoing legal scrutiny over cannabis scheduling and use	Ensure compliance, transparent reporting

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Key Takeaways

• Syndros is positioned as a premium, FDA-approved synthetic THC product with stable growth prospects primarily within the U.S.
• Market expansion depends on regulatory support, reimbursement policies, and physician adoption.
• Competitive pressures from generics and alternative cannabinoid formulations create pricing and margin risks.
• Investment in pipeline development and geographic diversification’s key to unlocking significant upside.
• Industry shifts toward broader indications and combination therapies can accelerate revenue growth.

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FAQs

1. What is the primary market for SYNDROS?
   The primary market consists of patients with AIDS-related anorexia and chemotherapy-induced nausea in the U.S., with potential expansion into other therapeutic areas.

2. How does SYNDROS compare to generic dronabinol products?
   SYNDROS offers a proprietary liquid formulation with a patented delivery system, enabling physician ease of use and consistent dosing, often commanding a premium over generic capsules.

3. What are the major regulatory risks for SYNDROS?
   Changes in federal or state laws can influence prescribing practices. Reclassification of cannabis-derived products could impact marketability.

4. What are the key drivers of revenue growth for SYNDROS?
   Increasing patient eligibility, physician adoption driven by clinical data, and expanded insurance reimbursement are primary drivers.

5. How will emerging cannabinoid therapies impact SYNDROS?
   Competition from new products may erode market share, but innovative formulations and expanding indications can mitigate this risk.

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References

1. Market Data: Grand View Research, "Cannabinoid Therapeutics Market Size & Trends," 2023.
2. Regulatory: FDA, "FDA Approves Syndros for Nausea and Loss of Appetite," 2016.
3. Industry Analysis: Insight Pharma Reports, "Synthetic Cannabinoids and Market Outlook," 2022.
4. Legal Status & Policy: DEA official website, "Controlled Substances Scheduling," 2023.
5. Competitive Data: IQVIA, "Pharmaceutical Market Analytics," 2023.

(Note: All numbers and projections are estimates based on current data; actual market conditions may vary.)