ONSOLIS Drug Patent Profile

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

Onsolis is a drug marketed by Adalvo and is included in one NDA. There is one patent protecting this drug.

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

The generic ingredient in ONSOLIS is fentanyl citrate. There are thirty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Onsolis

A generic version of ONSOLIS was approved as fentanyl citrate by HIKMA on July 11^th, 1984.

Summary for ONSOLIS

International Patents:	44
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	5
Patent Applications:	4,087
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONSOLIS
DailyMed Link:	ONSOLIS at DailyMed

Recent Clinical Trials for ONSOLIS

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

Sponsor	Phase
University of Florida
University of Utah	N/A
Hospira, Inc.	Phase 4

See all ONSOLIS clinical trials

US Patents and Regulatory Information for ONSOLIS

ONSOLIS is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-001	Jul 16, 2009		DISCN	No	No			Y
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-004	Jul 16, 2009		DISCN	No	No			Y
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-002	Jul 16, 2009		DISCN	No	No			Y
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-003	Jul 16, 2009		DISCN	No	No			Y
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-005	Jul 16, 2009		DISCN	No	No			Y

Expired US Patents for ONSOLIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-005	Jul 16, 2009
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-003	Jul 16, 2009
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-005	Jul 16, 2009
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-001	Jul 16, 2009
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-004	Jul 16, 2009
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-003	Jul 16, 2009
Adalvo	ONSOLIS	fentanyl citrate	FILM;BUCCAL	022266-002	Jul 16, 2009

International Patents for ONSOLIS

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

Country	Patent Number	Title	Estimated Expiration
Germany	69923675
Hong Kong	1193566	吸收增強的經粘膜遞送裝置 (TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE)
Lithuania	3265126
Japan	2009544619
South Korea	101999463
Serbia	62275	KOMBINOVANA FORMULACIJA TESOFENSINA I METOPROLOLA (TESOFENSINE AND METOPROLOL COMBINATION FORMULATION)
China	101511337	Transmucosal delivery devices with enhanced uptake

Supplementary Protection Certificates for ONSOLIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0836511	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID
1635783	CA 2014 00016	Denmark		PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
0383579	C960030	Netherlands		PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006

ONSOLIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ONSOLIS

Introduction to ONSOLIS

ONSOLIS, also known as BREAKYL™ in Europe, is a Transmucosal Immediate-Release Fentanyl (TIRF) film designed for the management of breakthrough pain in cancer patients aged 18 and older. This product is a significant player in the opioid market, particularly in the segment focused on pain management.

Approval and Regulatory Landscape

ONSOLIS received FDA approval in the U.S. and has been approved through the European Union's Decentralized Procedure, with Germany acting as the reference member state. The FDA approval triggered significant milestone payments to BioDelivery Sciences International, Inc., the developer, from its commercial partner, Meda AB[2][4].

Market Segmentation and Growth

The opioid market, within which ONSOLIS operates, is segmented by application, route of administration, and distribution channels. ONSOLIS falls under the pain relief application segment, which is a major driver of the opioid market. The market is expected to grow at a CAGR of 1.4% from 2023 to 2030, driven by the approval and launch of new opioid medicines[1].

Route of Administration

ONSOLIS is administered transmucosally, which is part of the "others" segment in terms of route of administration. However, its unique delivery mechanism sets it apart. The injectable segment currently holds the largest revenue share, but oral and other segments, including transmucosal products like ONSOLIS, are expected to grow significantly[1].

Distribution Channels

The product is distributed through various channels, with retail pharmacies accounting for the largest revenue share. This easy availability at retail pharmacies is expected to drive growth in this segment[1].

Financial Performance and Milestones

The financial performance of ONSOLIS has been marked by several key milestones:

• Milestone Payments: BioDelivery Sciences International, Inc. received $26.8 million in approval milestones from Meda AB, including $2.5 million for the first national approval in the EU and another $2.5 million upon the first commercial sale in the EU[2].
• Royalty Revenue: The company began receiving royalties from Meda on net sales of ONSOLIS in the U.S. and Canada, and from BREAKYL™ in the EU. However, royalty revenue has been below original projections due to regulatory conditions[2].

Challenges and Resolutions

ONSOLIS faced challenges related to its formulation, specifically issues with crystal formation and fading. These issues were addressed through reformulation, and discussions with Meda and the FDA were ongoing to resolve these problems. The revised formulation was submitted for FDA review, and the plan was to reintroduce the current formulation with a reduced shelf life until the new formulation was approved[2].

Partnerships and Licensing

The marketing rights for ONSOLIS in the U.S. were licensed to Collegium Pharmaceutical, Inc. This deal included an upfront payment of $2.5 million to BioDelivery Sciences International, Inc., along with reimbursement for remaining expenses associated with the transfer. This partnership leverages Collegium's commercial infrastructure to support responsible opioid prescribing[4][5].

Market Impact and Competition

ONSOLIS is highly complementary to other opioid products, such as Xtampza™ ER, allowing for comprehensive pain management strategies. The product's unique delivery mechanism and focus on breakthrough pain in cancer patients position it as a valuable asset in the pain management market. However, the opioid market is highly competitive, with major players like Purdue Pharma L.P., Allergan, and Pfizer, Inc.[1][4].

Regional Growth

While North America holds the largest share of the opioid market, the Asia Pacific region is expected to grow at the fastest CAGR of 5.5% during the forecast period. Initiatives to control opioid misuse and improve access to high-quality opioids for pain management are driving this growth[1].

Financial Implications and Patient Access

The cost of ONSOLIS, like other opioid medications, can contribute to financial toxicity for patients. High drug prices, particularly in the U.S., are driven by factors such as research and development costs, profit motives, and lack of price regulation. Patient access programs and cost-management strategies are essential to mitigate these financial burdens[3].

Key Takeaways

• Regulatory Approvals: ONSOLIS has received FDA and EU approvals, triggering significant milestone payments.
• Market Growth: The opioid market, including ONSOLIS, is expected to grow at a CAGR of 1.4% from 2023 to 2030.
• Financial Performance: ONSOLIS has generated revenue through milestone payments and royalties, though below initial projections.
• Partnerships: Licensing agreements with companies like Collegium Pharmaceutical, Inc. have enhanced its market presence.
• Financial Implications: High drug costs can lead to financial toxicity, emphasizing the need for patient access programs.

FAQs

What is ONSOLIS used for?

ONSOLIS is a Transmucosal Immediate-Release Fentanyl (TIRF) film used for the management of breakthrough pain in cancer patients aged 18 and older[4].

How was ONSOLIS approved?

ONSOLIS received FDA approval in the U.S. and was approved through the European Union's Decentralized Procedure, with Germany acting as the reference member state[2][4].

What are the financial milestones associated with ONSOLIS?

BioDelivery Sciences International, Inc. received $26.8 million in approval milestones from Meda AB, including $2.5 million for the first national approval in the EU and another $2.5 million upon the first commercial sale in the EU[2].

What challenges did ONSOLIS face, and how were they addressed?

ONSOLIS faced issues with crystal formation and fading, which were addressed through reformulation. The revised formulation was submitted for FDA review to resolve these problems[2].

Who are the key partners involved in the marketing of ONSOLIS?

The marketing rights for ONSOLIS in the U.S. were licensed to Collegium Pharmaceutical, Inc., which leverages its commercial infrastructure to support responsible opioid prescribing[4][5].

Cited Sources:

1. Grand View Research - Opioids Market Size, Share & Growth Analysis Report, 2030
2. BioDelivery Sciences International, Inc. - Annual Reports
3. Oxford University Press - Financial challenges of being on long-term, high-cost medications
4. Collegium Pharmaceutical, Inc. - Collegium Licenses the U.S. rights to ONSOLIS® from BioDelivery Sciences
5. FiercePharma - BioDelivery inks marketing deal with Collegium for U.S. rights to painkiller ONSOLIS