SUMAVEL DOSEPRO Drug Patent Profile

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

Sumavel Dosepro is a drug marketed by Endo Operations and is included in one NDA. There are three patents protecting this drug.

This drug has fourteen patent family members in eight countries.

The generic ingredient in SUMAVEL DOSEPRO is sumatriptan succinate. There are twenty-four drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the sumatriptan succinate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sumavel Dosepro

A generic version of SUMAVEL DOSEPRO was approved as sumatriptan succinate by WEST-WARD PHARMS INT on February 6^th, 2009.

Summary for SUMAVEL DOSEPRO

International Patents:	14
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	1
Patent Applications:	2,223
Drug Prices:	Drug price information for SUMAVEL DOSEPRO
What excipients (inactive ingredients) are in SUMAVEL DOSEPRO?	SUMAVEL DOSEPRO excipients list
DailyMed Link:	SUMAVEL DOSEPRO at DailyMed

See drug prices for SUMAVEL DOSEPRO

Recent Clinical Trials for SUMAVEL DOSEPRO

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

Sponsor	Phase
Synteract, Inc.	Phase 4
Zogenix, Inc.	Phase 4

See all SUMAVEL DOSEPRO clinical trials

US Patents and Regulatory Information for SUMAVEL DOSEPRO

SUMAVEL DOSEPRO is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-002	Nov 26, 2013		DISCN	Yes	No
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009		DISCN	Yes	No			Y
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009		DISCN	Yes	No			Y
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009		DISCN	Yes	No			Y

Expired US Patents for SUMAVEL DOSEPRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009
Endo Operations	SUMAVEL DOSEPRO	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	022239-001	Jul 15, 2009

International Patents for SUMAVEL DOSEPRO

See the table below for patents covering SUMAVEL DOSEPRO around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4504688
Denmark	0876175
Germany	69508792
Slovakia	139398	SPRING-POWERED DISPENSING DEVICE FOR MEDICAL PURPOSES
Czech Republic	9803266
Australia	2038797
Canada	2251256

SUMAVEL DOSEPRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sumavel DosePro

Introduction

Sumavel DosePro, developed by Zogenix, Inc., is a needle-free, subcutaneous delivery system of sumatriptan, designed for the acute treatment of migraine and cluster headache. Here, we delve into the market dynamics and financial trajectory of this innovative drug.

Market Potential and Demand

Migraine is a significant health issue, affecting over 29.5 million people in the United States alone, according to the National Headache Foundation[2][3].

• Triptans Market: Sumavel DosePro competes in the triptans market, which is a dominant segment for migraine treatments. In the 12 months ended December 2012, triptans generated sales of approximately $4.4 billion, with sumatriptan (including branded and generic forms) holding the largest market share of about $2.6 billion[3].

Competitive Advantage

• Convenience and Efficacy: Sumavel DosePro offers a convenient, needle-free administration, which can provide migraine pain relief in as little as ten minutes for some patients. This makes it an attractive alternative to traditional oral and nasal triptans and needle-based sumatriptan injections[1][3][4].

Commercialization and Sales Strategy

• Launch and Partnerships: Sumavel DosePro was launched in the United States in January 2010 with Astellas Pharma US, Inc. as the co-promotion partner. After the co-promotion agreement terminated in March 2012, Zogenix assumed full responsibility for its commercialization and later entered into a co-promotion agreement with Mallinckrodt[2][3].
• Sales Performance: By December 31, 2010, total U.S. gross sales to wholesalers of Sumavel DosePro were $25.3 million, with net product revenue of $18.7 million from over 35,200 dispensed prescriptions. By December 31, 2012, the total U.S. net product revenue from sales of Sumavel DosePro had increased to $84.5 million[2][3].

Reimbursement and Coverage

• Third-Party Payors: Zogenix has worked to secure broad coverage for Sumavel DosePro. As of the reports, the reimbursement claims approval rate was approximately 83% since its launch, indicating strong acceptance by third-party payors[1][3].

Global Expansion

• European Market: Zogenix partnered with Desitin to commercialize Sumavel DosePro in Europe. The product received marketing approvals in several European countries, including Denmark, Germany, Sweden, Norway, and the United Kingdom[1][2][3].

Financial Performance

• Revenue Growth: The financial performance of Sumavel DosePro showed significant growth in its early years. From $18.7 million in net product revenue in 2010 to $84.5 million by the end of 2012, the drug demonstrated a strong market presence[2][3].
• Decline and Wind-Down: However, by the third quarter of 2017, Zogenix reported no revenue from Sumavel DosePro due to the wind-down of its manufacturing operations. This decline was part of a broader strategic shift in the company's product portfolio[5].

Challenges and Risks

• Regulatory and Safety Concerns: The drug faced regulatory challenges, including the potential for adverse side effects or inadequate therapeutic efficacy, which could result in product recalls or market withdrawals. Additionally, there were risks associated with obtaining and maintaining adequate patent and intellectual property protection[1][2][3].
• Market Competition: The market for migraine treatments is highly competitive, with Sumavel DosePro competing against established oral and nasal triptans. The ability to maintain market demand and sales was a significant challenge[1][3].

Strategic Focus

• DosePro Technology: Zogenix aimed to leverage the DosePro technology by out-licensing it to other companies, enabling them to enhance or extend the life cycle of their injectable products. This strategy was part of their broader goal to develop and commercialize differentiated CNS and pain therapeutics[2][3].

Key Takeaways

• Market Need: Sumavel DosePro addressed a significant unmet medical need in the treatment of migraines and cluster headaches.
• Commercial Success: The drug achieved notable commercial success in its initial years, with strong sales and reimbursement rates.
• Challenges: Despite its advantages, the drug faced regulatory, safety, and competitive challenges.
• Strategic Shift: The eventual wind-down of manufacturing operations marked a strategic shift for Zogenix, focusing on other product candidates.

FAQs

1. What is Sumavel DosePro used for? Sumavel DosePro is used for the acute treatment of migraine with or without aura and the acute treatment of cluster headache in adults[4].

2. How is Sumavel DosePro administered? Sumavel DosePro is administered subcutaneously using a needle-free delivery system, with doses of 4 mg or 6 mg available[4].

3. What were the key factors in the commercial success of Sumavel DosePro? The convenience of needle-free administration, rapid onset of pain relief, and strong co-promotion partnerships contributed to its commercial success[1][2][3].

4. Why did Zogenix wind down the manufacturing operations for Sumavel DosePro? The exact reasons for the wind-down are not specified, but it was part of a broader strategic shift in the company's product portfolio[5].

5. What is the current market status of Sumavel DosePro? As of the latest reports, Zogenix has ceased manufacturing operations for Sumavel DosePro, indicating a significant decline in its market presence[5].

Cited Sources:

1. Zogenix, Inc. - Annual Reports (2013)
2. Zogenix, Inc. - Annual Reports (2010)
3. Zogenix, Inc. - Annual Reports (2012)
4. Sumavel Dosepro: Package Insert / Prescribing Information
5. Zogenix Provides Corporate Update and Reports Third Quarter 2017 Financial Results