syndros Drug Patent Profile

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

Syndros is a drug marketed by Benuvia Operations 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. Nine 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	3
Patent Applications:	3,944
Drug Prices:	Drug price information for syndros
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for syndros
What excipients (inactive ingredients) are in syndros?	syndros excipients list
DailyMed Link:	syndros at DailyMed

See drug prices for syndros

Recent Clinical Trials for syndros

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Yale University	Phase 1
National Institute on Drug Abuse (NIDA)	Phase 1
Jeffrey L Gum MD	Phase 4

See all syndros clinical trials

Pharmacology for syndros

Drug Class

Cannabinoid

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
Benuvia Operations	SYNDROS	dronabinol	SOLUTION;ORAL	205525-001	Mar 23, 2017		DISCN	Yes	No	10,265,293		Y	Y
Benuvia Operations	SYNDROS	dronabinol	SOLUTION;ORAL	205525-001	Mar 23, 2017		DISCN	Yes	No	8,222,292		Y	Y
Benuvia Operations	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
Japan	2010535774
European Patent Office	2184983	FORMULATIONS LIQUIDES À USAGE ORAL DE CANNABINOÏDES ET PROCÉDÉS DE TRAITEMENT AVEC CELLES-CI (ORAL CANNABINOID LIQUID FORMULATIONS AND METHODS OF TREATMENT)
World Intellectual Property Organization (WIPO)	2009020666

Syndros Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Syndros

Introduction

Syndros, a liquid form of the synthetic cannabinoid dronabinol, was approved by the US Food and Drug Administration (FDA) in 2016. This drug is manufactured by Insys Therapeutics and is prescribed for patients with AIDS-related anorexia and weight loss, as well as for those undergoing chemotherapy who suffer from nausea and vomiting that has not responded to conventional treatments.

Approval and Regulatory Status

Syndros was approved under a New Drug Application (NDA) and is classified as a Schedule II controlled substance by the Drug Enforcement Agency, indicating a high potential for abuse but also accepted medical use[4].

Market Positioning

Syndros enters a market where other cannabinoid-based drugs are already present, such as Marinol (another form of dronabinol) and Sativex (a combination of CBD and THC). However, Syndros is the first liquid form of dronabinol, which could offer advantages in terms of ease of administration and potentially reduced risk of abuse compared to capsule forms[4].

Financial Projections

The financial trajectory for Syndros is modest compared to other cannabinoid-based drugs. According to Evaluate Pharma forecasts, Syndros is projected to achieve significantly lower sales than Epidiolex, another prominent cannabinoid-based drug.

• By 2021, Syndros was expected to generate only $52 million in sales, a fraction of the $1.04 billion projected for Epidiolex[1].
• By 2024, Syndros sales were forecasted to reach $90 million, still a minor figure compared to the total market size for cannabinoid-based drugs, which was projected to be $2.485 billion, with Epidiolex dominating the market[1].

Market Growth and Competition

The market for cannabinoid-based drugs is growing, but it is not expected to become a major sub-segment of the pharmaceutical market in the near future. Barbara Gilmore of Frost & Sullivan noted that while Epidiolex is expected to achieve blockbuster status, other cannabinoid-based drugs, including Syndros, will not reach the same level of sales[1].

Challenges and Controversies

Syndros faces several challenges, including competition from medical marijuana and other synthetic cannabinoids. The approval of Syndros has also sparked controversy, particularly among pro-legalization groups, due to Insys Therapeutics' involvement in opposing marijuana legalization efforts in Arizona[4].

Safety and Efficacy

Despite the controversies, Syndros is seen as a safer alternative to medical marijuana due to its regulated manufacturing process and precise dosing. This could make it an attractive option for patients and physicians looking for a controlled and reliable treatment for specific health issues[4].

Future Outlook

The future of Syndros depends on several factors, including its ability to navigate the complex regulatory landscape and compete with other treatments. While it may not achieve the same level of sales as Epidiolex, Syndros could still carve out a niche for itself in the market for treating specific conditions such as AIDS-related anorexia and chemotherapy-induced nausea and vomiting.

Key Takeaways

• Regulatory Approval: Syndros is approved under an NDA and classified as a Schedule II controlled substance.
• Market Position: It is the first liquid form of dronabinol, offering potential advantages over capsule forms.
• Financial Projections: Modest sales projections compared to other cannabinoid-based drugs.
• Market Growth: Part of a growing but not dominant market segment for cannabinoid-based drugs.
• Challenges: Faces competition from medical marijuana and controversy over Insys Therapeutics' actions.

FAQs

1. What is Syndros used for? Syndros is used to treat patients with AIDS-related anorexia and weight loss, as well as those undergoing chemotherapy who suffer from nausea and vomiting that has not responded to conventional treatments[4].

2. How is Syndros administered? Syndros is administered as a liquid form of the synthetic cannabinoid dronabinol, which can be easier to use than capsule forms[4].

3. What is the regulatory status of Syndros? Syndros is classified as a Schedule II controlled substance by the Drug Enforcement Agency and was approved under a New Drug Application (NDA)[4].

4. How does Syndros compare to other cannabinoid-based drugs in terms of sales? Syndros is projected to achieve significantly lower sales than Epidiolex, with forecasts indicating $90 million in sales by 2024 compared to Epidiolex's projected $2.349 billion[1].

5. What controversies surround Syndros? Syndros has sparked controversy due to Insys Therapeutics' involvement in opposing marijuana legalization efforts in Arizona, despite the company's vested financial interest in the outcome[4].

Sources

1. Genetic Engineering & Biotechnology News: Cannabinoid-Based Drugs Seek New High, Part I
2. UCB USA: UCB on Growth Path for a Decade Plus
3. GlobeNewswire: Drug Delivery Devices Market Surges Towards USD 713.1 Billion by 2033
4. MedCentral: FDA Approves Syndros, First Liquid Form of Cannabinoid Dronabinol
5. BioPharma Dive: Insys stages recovery as FDA approves liquid THC drug