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ZAVZPRET Drug Patent Profile

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

Zavzpret is a drug marketed by Pfizer and is included in one NDA. There are two patents protecting this drug.

This drug has seventy-one patent family members in thirty-five countries.

The generic ingredient in ZAVZPRET is zavegepant hydrochloride. Two suppliers are listed for this compound. Additional details are available on the zavegepant hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Zavzpret

Zavzpret will be eligible for patent challenges on March 9, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 9, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZAVZPRET

International Patents:	71
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	21
Drug Prices:	Drug price information for ZAVZPRET
What excipients (inactive ingredients) are in ZAVZPRET?	ZAVZPRET excipients list
DailyMed Link:	ZAVZPRET at DailyMed

See drug prices for ZAVZPRET

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZAVZPRET

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216386

Dosage:

SPRAY, METERED;NASAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ZAVZPRET

Drug Class	Calcitonin Gene-related Peptide Receptor Antagonist
Mechanism of Action	Calcitonin Gene-related Peptide Receptor Antagonists

US Patents and Regulatory Information for ZAVZPRET

ZAVZPRET is protected by two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386-001	Mar 9, 2023		RX	Yes	Yes	8,481,546		Y	Y
Pfizer	ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386-001	Mar 9, 2023		RX	Yes	Yes	7,220,862		Y	Y
Pfizer	ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386-001	Mar 9, 2023		RX	Yes	Yes

Expired US Patents for ZAVZPRET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386-001	Mar 9, 2023	7,220,862
Pfizer	ZAVZPRET	zavegepant hydrochloride	SPRAY, METERED;NASAL	216386-001	Mar 9, 2023	7,314,883

International Patents for ZAVZPRET

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

Country	Patent Number	Title	Estimated Expiration
Denmark	2552906
Serbia	52552	ANTAGONISTI, PEPTIDNOG RECEPTORA KOJI JE U VEZI SA KALCITONINSKIM GENOM (CALCITONIN GENE RELATED PEPTIDE RECEPTOR ANTAGONISTS)
European Patent Office	2552906	ANTAGONISTE DES RÉCEPTEURS CGRP (CGRP RECEPTOR ANTAGONIST)

ZAVZPRET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zavzpret

Introduction to Zavzpret

Zavzpret, formerly known as zavegepant, is a nasal spray approved by the FDA as an acute treatment for adults with migraines. This drug is a significant addition to Pfizer's portfolio, following the company's acquisition of Biohaven Pharmaceuticals in May 2022[1].

Market Need and Competition

The migraine treatment market is highly competitive, with several established players like Eli Lilly and AbbVie. However, Zavzpret offers a unique advantage as a nasal spray, which can avoid gastrointestinal side effects common in oral migraine medications. This makes it an attractive option for patients who experience nausea or vomiting during migraine attacks[1].

Clinical Efficacy and Safety

Clinical trials have shown that Zavzpret provides rapid pain relief, with benefits observed over placebo in as little as 15 minutes and lasting for one to two days. The most common side effects reported include altered taste and nasal discomfort. The drug's quick action and alternative delivery method position it well in the market[1].

Pricing and Access

Pfizer has indicated that the price of Zavzpret will be comparable to other marketed migraine drugs. The company is actively engaging with payers and pharmacy benefit managers to ensure access to the drug. This strategic pricing and access plan is crucial for the drug's commercial success[1].

Financial Impact on Pfizer

The acquisition of Biohaven Pharmaceuticals, which included Zavzpret and another migraine drug, Nurtec ODT, was a $12 billion investment for Pfizer. This deal is expected to offset some of the declines in Pfizer's COVID-19 treatment sales and patent expirations for other medicines. Pfizer predicts that Zavzpret and Nurtec ODT will achieve combined peak yearly sales of over $6 billion[1].

Revenue Contributions

In the first quarter of 2023, recently acquired products, including Nurtec ODT, contributed significantly to Pfizer's revenues. While specific figures for Zavzpret are not yet available, the drug is expected to add substantial revenue as it becomes available in pharmacies. The integration of these products into Pfizer's portfolio is part of the company's strategy to drive growth in the second half of 2023[3][5].

Royalty Payments

The FDA approval of Zavzpret triggered a $475 million payment to Royalty Pharma, which had a financing deal with Biohaven Pharmaceuticals. Royalty Pharma is entitled to royalties on the combined global sales of Nurtec and Zavzpret, with rates varying based on sales thresholds. This deal underscores the financial commitments and potential returns associated with Zavzpret's commercial success[4].

Market Growth Potential

Pfizer's confidence in Zavzpret's growth potential is high, given the drug's unique benefits and the large market for migraine treatments. The quick absorption and efficacy of the nasal spray are expected to attract a significant patient base, contributing to substantial revenue growth for Pfizer.

Expert Insights

"Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works," said Kathleen Mullin, the associate medical director at the New England Institute for Neurology & Headache. "As a nasal spray with rapid drug absorption, Zavzpret offers an alternative treatment option for people who need pain relief or cannot take oral medications due to nausea or vomiting, so they can get back to normal function quickly"[1].

Financial Performance of Pfizer

In the first quarter of 2023, Pfizer reported revenues of $18.3 billion, with a decline primarily driven by lower COVID-19 treatment sales. However, excluding these contributions, Pfizer's revenues grew 5% operationally, driven in part by recently acquired products like Nurtec ODT. This growth trend is expected to continue, with significant contributions from new product launches, including Zavzpret[3][5].

Future Outlook

Pfizer is executing on an unprecedented number of new product and indication launches, with Zavzpret being a key component of this strategy. The company's strong balance sheet and integration planning for future acquisitions, such as Seagen, position Pfizer for continued growth and flexibility in business development activities[5].

Key Takeaways

• Unique Delivery Method: Zavzpret's nasal spray delivery avoids gastrointestinal side effects, offering a unique advantage in the migraine treatment market.
• Rapid Efficacy: Clinical trials show benefits in as little as 15 minutes, with pain relief lasting one to two days.
• Financial Potential: Predicted to achieve over $6 billion in combined peak yearly sales with Nurtec ODT.
• Royalty Commitments: Triggers significant royalty payments to Royalty Pharma based on sales performance.
• Market Growth: Expected to contribute substantially to Pfizer's revenue growth in the second half of 2023.

FAQs

Q: What is Zavzpret, and how is it used? A: Zavzpret is a nasal spray approved for the acute treatment of migraines in adults. It works by inhibiting CGRP, a protein released during migraine attacks.

Q: How quickly does Zavzpret provide relief? A: Clinical trials show that Zavzpret provides benefits over placebo in as little as 15 minutes, with pain relief lasting one to two days.

Q: What are the common side effects of Zavzpret? A: The most common side effects reported include altered taste and nasal discomfort.

Q: How much did Pfizer pay for the rights to Zavzpret? A: Pfizer acquired Biohaven Pharmaceuticals, which included Zavzpret, in a deal valued at approximately $12 billion.

Q: What are the royalty payments associated with Zavzpret? A: The FDA approval of Zavzpret triggered a $475 million payment to Royalty Pharma, with ongoing royalties based on sales performance.

Cited Sources

1. BioPharma Dive: "Pfizer's Biohaven deal pays dividends with new drug approval"
2. BioSpace: "Pfizer Reports First-Quarter 2023 Results"
3. Business Wire: "Pfizer Reports First-Quarter 2023 Results"
4. MedCity News: "Pfizer's Migraine Drug Approval Triggers $475M Payment to Royalty Pharma"
5. Pfizer: "Q1-2023-PFE-Earnings-Release.pdf"