ZOMIG-ZMT Drug Patent Profile

When do Zomig-zmt patents expire, and what generic alternatives are available?

Zomig-zmt is a drug marketed by Astrazeneca and is included in one NDA.

The generic ingredient in ZOMIG-ZMT 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-zmt

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

Summary for ZOMIG-ZMT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	99
Patent Applications:	4,660
DailyMed Link:	ZOMIG-ZMT at DailyMed

US Patents and Regulatory Information for ZOMIG-ZMT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	ZOMIG-ZMT	zolmitriptan	TABLET, ORALLY DISINTEGRATING;ORAL	021231-001	Feb 13, 2001		DISCN	Yes	No
Astrazeneca	ZOMIG-ZMT	zolmitriptan	TABLET, ORALLY DISINTEGRATING;ORAL	021231-002	Sep 17, 2001		DISCN	Yes	No

Expired US Patents for ZOMIG-ZMT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	ZOMIG-ZMT	zolmitriptan	TABLET, ORALLY DISINTEGRATING;ORAL	021231-001	Feb 13, 2001
Astrazeneca	ZOMIG-ZMT	zolmitriptan	TABLET, ORALLY DISINTEGRATING;ORAL	021231-002	Sep 17, 2001

International Patents for ZOMIG-ZMT

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

Country	Patent Number	Title	Estimated Expiration
Slovakia	281621
Russian Federation	2160736	ПРОИЗВОДНЫЕ ИНДОЛА И ИХ ФИЗИОЛОГИЧЕСКИ ПРИЕМЛЕМЫЕ СОЛИ И СОЛЬВАТЫ, СПОСОБЫ ИХ ПОЛУЧЕНИЯ, ЛЕКАРСТВЕННОЕ СРЕДСТВО ДЛЯ ЛЕЧЕНИЯ ИЛИ ПРОФИЛАКТИКИ КЛИНИЧЕСКИХ СОСТОЯНИЙ, ДЛЯ КОТОРЫХ ПОКАЗАН ПРИЕМ АГОНИСТА "5-НТ1-ПОДОБНОГО" РЕЦЕПТОРА, И СПОСОБ ЕГО ПОЛУЧЕНИЯ (INDOLE DERIVATIVES AND PHYSIOLOGICALLY ACCEPTABLE SALTS AND SOLVATES THEREOF, METHODS OF PREPARING THEREOF, DRUG FOR TREATMENT OR PROPHYLAXES OF CLINICAL STATES FOR WHICH ADMINISTRATION OF 5-HT1-LIKE RECEPTOR AGONIST, AND METHOD OF PREPARING THEREOF)
Slovenia	9111010	3,5-DISUBSTITUTED INDOLE DERIVATIVES AS "5-HT1-SIMILAR" RECEPTOR AGONISTS
Germany	69132691
Australia	7957091

Supplementary Protection Certificates for ZOMIG-ZMT

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-ZMT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZOMIG-ZMT

Introduction

ZOMIG-ZMT, a medication for the acute treatment of migraines and cluster headaches, has undergone significant changes in its market dynamics and financial trajectory over the years. Here, we will delve into the key aspects of its market and financial performance.

Drug Overview

ZOMIG-ZMT, containing the active ingredient zolmitriptan, is indicated for the acute treatment of migraines and cluster headaches. It is available in various forms, including conventional tablets and orally disintegrating tablets[3].

Market Presence and Licensing Agreements

Global Rights and Licensing

In 2017, AstraZeneca entered into an agreement with Grünenthal to divest the global rights to ZOMIG (zolmitriptan) for all markets outside of Japan. Grünenthal paid $200 million upon completion of the deal and agreed to up to $102 million in additional milestone payments. This arrangement included the rights in the U.S., where ZOMIG had been licensed to Impax Pharmaceuticals since 2012[1][2].

U.S. Commercialization

Impax Pharmaceuticals acquired the exclusive U.S. commercialization rights to ZOMIG from AstraZeneca in 2012. At the time, ZOMIG had U.S. net sales of $163 million for the twelve months ended September 30, 2011. Impax expected ZOMIG to contribute significantly to its revenues and earnings in 2012 and 2013, particularly through the nasal spray dosage form[4][5].

Financial Performance

Revenue and Sales

In 2016, revenues from ZOMIG outside Japan were $96 million, including product sales and externalization revenue. This figure indicates the drug's steady revenue stream before the divestment to Grünenthal[2].

Impact of Divestment

The sale of ZOMIG rights to Grünenthal was part of AstraZeneca's broader strategy to raise cash and focus on its core therapeutic areas. This move was critical for AstraZeneca, which was facing financial challenges, including declining revenues due to patent expirations and generic competition, particularly for its high-cholesterol blockbuster Crestor[1].

Milestone Payments and Financial Considerations

The deal with Grünenthal included potential milestone payments of up to $102 million, which could further bolster AstraZeneca's financial position. The transaction was expected to complete in the second quarter of 2017 and was reported as Other Operating Income in AstraZeneca's financial statements[2].

Market Dynamics

Competitive Landscape

The migraine treatment market is highly competitive, with several other triptans and newer treatments such as CGRP inhibitors. However, ZOMIG's established presence and Grünenthal's expertise in pain management positioned the drug well within this competitive landscape[2].

Patient Needs and Market Demand

Migraine is a debilitating disease affecting over 75 million people worldwide. The acquisition of ZOMIG by Grünenthal was seen as a strategic move to address this significant patient need and complement Grünenthal's existing pain portfolio. Grünenthal aimed to become a €2 billion company by 2022, with ZOMIG playing a crucial role in this ambition[2].

Strategic Implications

AstraZeneca's Portfolio Strategy

AstraZeneca's decision to divest ZOMIG was part of its broader portfolio strategy to focus on core therapeutic areas and manage financial pressures. This strategy involved selling off several assets, including antibiotics to Pfizer and an anesthetics portfolio to Aspen Pharmacare[1].

Grünenthal's Growth Plans

For Grünenthal, the acquisition of ZOMIG was a key step in expanding its pain management portfolio and achieving its growth targets. Grünenthal planned to bring four to five innovative products to market by 2022, with ZOMIG contributing to this effort[2].

Clinical Efficacy and Patient Response

Clinical Trials and Efficacy

ZOMIG-ZMT has demonstrated significant efficacy in clinical trials. For example, a randomized, placebo-controlled trial showed that 63% of patients treated with ZOMIG-ZMT 2.5 mg achieved headache response at 2 hours, compared to 22% in the placebo group[3].

Patient Benefits

The drug's efficacy in reducing migraine symptoms, including sensitivity to light or sound, nausea, and vomiting, makes it a valuable treatment option for patients. Grünenthal's commitment to ensuring patients continue to benefit from ZOMIG aligns with the company's mission to improve patient outcomes in pain management[2].

Conclusion

The market dynamics and financial trajectory of ZOMIG-ZMT have been shaped by significant licensing agreements, divestments, and strategic portfolio decisions. Here are the key takeaways:

• Licensing and Divestment: AstraZeneca divested the global rights to ZOMIG to Grünenthal in 2017, receiving $200 million and potential milestone payments.
• U.S. Commercialization: Impax Pharmaceuticals has been responsible for the U.S. commercialization of ZOMIG since 2012.
• Financial Performance: ZOMIG generated $96 million in revenues outside Japan in 2016 and was expected to contribute to Grünenthal's growth plans.
• Market Dynamics: The drug operates in a competitive migraine treatment market but is well-positioned due to Grünenthal's pain management expertise.
• Strategic Implications: The divestment was part of AstraZeneca's portfolio strategy, while Grünenthal aimed to expand its pain management portfolio.

Key Takeaways

• ZOMIG-ZMT is a clinically effective treatment for migraines and cluster headaches.
• The drug's market presence has been influenced by licensing agreements and divestments.
• Grünenthal's acquisition is part of its strategy to become a €2 billion company by 2022.
• AstraZeneca's divestment reflects its focus on core therapeutic areas and financial management.

FAQs

Q: What is ZOMIG-ZMT used for?

A: ZOMIG-ZMT is used for the acute treatment of migraines and cluster headaches.

Q: Who currently holds the global rights to ZOMIG outside Japan?

A: Grünenthal holds the global rights to ZOMIG outside Japan, acquired from AstraZeneca in 2017.

Q: How much did Grünenthal pay for the rights to ZOMIG?

A: Grünenthal paid $200 million upon completion of the deal and agreed to up to $102 million in additional milestone payments.

Q: Who is responsible for the U.S. commercialization of ZOMIG?

A: Impax Pharmaceuticals is responsible for the U.S. commercialization of ZOMIG.

Q: What were the revenues from ZOMIG outside Japan in 2016?

A: The revenues from ZOMIG outside Japan in 2016 were $96 million.

Sources

1. FiercePharma: AstraZeneca offloads headache drug Zomig to Grünenthal to raise $300m cash.
2. AstraZeneca: AstraZeneca enters agreement with Grünenthal to divest rights to migraine treatment Zomig.
3. FDA: ZOMIG TABLETS ZOMIG-ZMT ORALLY DISINTEGRATING TABLETS.
4. BusinessWire: Impax Pharmaceuticals Licenses Exclusive U.S. Commercialization Rights to Zomig® from AstraZeneca.
5. FierceBiotech: Impax Pharmaceuticals Licenses Exclusive U.S. Commercialization Rights to Zomig®.