ZOMIG Drug Patent Profile

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

Zomig is a drug marketed by Amneal, IPR, and Astrazeneca. and is included in three NDAs.

The generic ingredient in ZOMIG is zolmitriptan. There are twenty drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the zolmitriptan profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zomig

A generic version of ZOMIG was approved as zolmitriptan by GLENMARK PHARMS LTD on May 14^th, 2013.

Summary for ZOMIG

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	99
Patent Applications:	4,573
Drug Prices:	Drug price information for ZOMIG
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOMIG
What excipients (inactive ingredients) are in ZOMIG?	ZOMIG excipients list
DailyMed Link:	ZOMIG at DailyMed

See drug prices for ZOMIG

Pharmacology for ZOMIG

Drug Class	Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Paragraph IV (Patent) Challenges for ZOMIG

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZOMIG	Nasal Spray	zolmitriptan	2.5 mg/spray	021450	1	2016-06-09
ZOMIG	Nasal Spray	zolmitriptan	5 mg/spray	021450	1	2013-11-14

US Patents and Regulatory Information for ZOMIG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-003	Sep 16, 2013	AB	RX	Yes	No
Ipr	ZOMIG	zolmitriptan	TABLET;ORAL	020768-002	Nov 25, 1997		DISCN	Yes	No
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-004	Sep 30, 2003	AB	RX	Yes	Yes
Ipr	ZOMIG	zolmitriptan	TABLET;ORAL	020768-001	Nov 25, 1997		DISCN	Yes	No
Astrazeneca	ZOMIG-ZMT	zolmitriptan	TABLET, ORALLY DISINTEGRATING;ORAL	021231-002	Sep 17, 2001		DISCN	Yes	No
Astrazeneca	ZOMIG-ZMT	zolmitriptan	TABLET, ORALLY DISINTEGRATING;ORAL	021231-001	Feb 13, 2001		DISCN	Yes	No

Expired US Patents for ZOMIG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-004	Sep 30, 2003	7,220,767*PED
Ipr	ZOMIG	zolmitriptan	TABLET;ORAL	020768-002	Nov 25, 1997	5,863,935*PED
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-003	Sep 16, 2013	6,750,237*PED
Ipr	ZOMIG	zolmitriptan	TABLET;ORAL	020768-001	Nov 25, 1997	5,863,935*PED
Ipr	ZOMIG	zolmitriptan	TABLET;ORAL	020768-001	Nov 25, 1997	5,466,699*PED
Amneal	ZOMIG	zolmitriptan	SPRAY;NASAL	021450-004	Sep 30, 2003	6,750,237*PED

International Patents for ZOMIG

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

Country	Patent Number	Title	Estimated Expiration
Finland	20001406
Taiwan	223072
Estonia	05305	Zolmitriptaani sisaldav ravimpreparaat, meetod selle valmistamiseks ning seda sisaldav intranasaalse manustamise vahend
Israel	114690	Antimigraine oxazolidinone substituted indole derivatives
Austria	204275
Japan	H05502679

Supplementary Protection Certificates for ZOMIG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0486666	72/1997	Austria		PRODUCT NAME: ZOLMITRIPTAN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ZULAESSIGEN SALZES; NAT. REGISTRATION NO/DATE: 1-22068, 1-22069 19970819; FIRST REGISTRATION: GB 12619/0116, 12619/0117 19970307
0463756	300048	Netherlands		PRODUCT NAME: ZOLMITRIPTANUM, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT OF VAN EEN SOLVAAT; NATL. REGISTRATION: RVG 21079 RVG 21080 19970925; FIRST REGISTRATION: PL 12619/0116 19970307
0486666	C980001	Netherlands		PRODUCT NAME: ZOLMITRIPTANUM, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT OF VAN EEN SOLVAAT; NAT. REGISTRATION NO/DATE: RVG 21079, RVG 21080 19970925; FIRST REGISTRATION: GB PL 12619/0116 19970307
0486666	SPC/GB97/089	United Kingdom		PRODUCT NAME: ZOLMITRIPTAN AND OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK 12619/0116 19970307

ZOMIG Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zomig (Zolmitriptan)

Introduction to Zomig

Zomig, also known as zolmitriptan, is a triptan-class medication used for the acute treatment of migraines and cluster headaches. It works by increasing serotonin levels in the brain, reducing inflammation, and constricting blood vessels to alleviate migraine symptoms.

Market Context

The migraine drugs market is expected to see significant growth over the next few years, driven by factors such as personalized medicine approaches, telemedicine, and increasing global migraine burden. The market size is projected to grow to $6.84 billion by 2028 at a compound annual growth rate (CAGR) of 6.2%[3].

Triptans Segment Growth

The triptans segment, which includes Zomig, is anticipated to grow at a healthy CAGR due to their higher efficacy compared to other newer pharmacologic agents like ditans and gepants. Triptans are more migraine-specific and have been shown to be more effective in alleviating migraine symptoms. For instance, sumatriptan and naproxen sodium (Treximet), a combination therapy, are more effective than either medication alone[4].

Acquisition and Licensing Agreements

In 2017, AstraZeneca entered an agreement with Grünenthal to divest the global rights to Zomig outside Japan. Grünenthal paid AstraZeneca $200 million upon completion and agreed to up to an additional $102 million in future milestone payments. This acquisition was part of Grünenthal's strategy to expand its pain portfolio and support its ambition to become a €2 billion company by 2022[1].

Financial Performance of Zomig

Prior to the divestment, revenues from Zomig outside Japan were $96 million in 2016, including product sales and externalization revenue. The transaction did not impact AstraZeneca’s financial guidance for 2017, and the net consideration was reported as Other Operating Income in the company’s financial statements[1].

Current Market Presence

After the acquisition, Grünenthal has continued to market and distribute Zomig globally, except in Japan. In the US, Impax Pharmaceuticals, which had previously licensed the rights from AstraZeneca, continues to market Zomig. This arrangement ensures that patients continue to have access to the medication while Grünenthal leverages its expertise in pain treatment to further develop and market the product[1].

Regional Market Dominance

North America, particularly the United States, is expected to hold a significant share of the migraine therapeutics market due to the high prevalence of migraines and the increasing adoption of novel therapeutics. The region's large target population and strategic activities by key market players, such as product launches and approvals, contribute to its dominance[4].

Challenges and Restraints

Despite the growth potential, the high cost of migraine treatment, including Zomig, is a significant restraint. The average price per prescription for migraine drugs has increased substantially, which may limit patients' access to effective treatments and impede market growth. For example, the average price per prescription for migraine drugs rose from $200 to $300 between periods[3].

Future Outlook

The future outlook for Zomig is positive, driven by the increasing demand for effective migraine treatments and the strategic positioning of Grünenthal in the pain management market. New product launches and approvals in the triptan class, along with the expanding reach of telemedicine and remote consultations, are expected to boost the market segment over the forecast period[4].

Key Takeaways

• Market Growth: The migraine drugs market, including Zomig, is expected to grow significantly due to personalized medicine, telemedicine, and increasing global migraine burden.
• Triptans Segment: Zomig, as part of the triptans segment, is expected to grow due to its higher efficacy compared to other pharmacologic agents.
• Acquisition and Licensing: Grünenthal's acquisition of Zomig rights has positioned the company to leverage its pain treatment expertise.
• Financial Performance: The divestment of Zomig rights generated significant revenue for AstraZeneca and is expected to contribute to Grünenthal's financial growth.
• Regional Dominance: North America, particularly the US, will continue to dominate the market due to high migraine prevalence and adoption of novel therapeutics.
• Challenges: High treatment costs may restrain market growth and limit patient access.

FAQs

Q: What is Zomig used for? A: Zomig (zolmitriptan) is used for the acute treatment of migraines and cluster headaches.

Q: Who acquired the global rights to Zomig outside Japan? A: Grünenthal acquired the global rights to Zomig outside Japan from AstraZeneca in 2017.

Q: What was the financial consideration for the acquisition of Zomig rights? A: Grünenthal paid AstraZeneca $200 million upon completion and up to an additional $102 million in future milestone payments.

Q: How does Zomig work? A: Zomig works by increasing serotonin levels in the brain, reducing inflammation, and constricting blood vessels to alleviate migraine symptoms.

Q: What are the challenges facing the growth of the migraine drug market, including Zomig? A: The high cost of migraine treatment is a significant restraint, limiting patients' access to effective treatments and potentially impeding market growth.