OHTUVAYRE Drug Patent Profile

Name: OHTUVAYRE Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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Which patents cover Ohtuvayre, and what generic alternatives are available?

Ohtuvayre is a drug marketed by MSD and is included in one NDA. There are five patents protecting this drug.

The generic ingredient in OHTUVAYRE is ensifentrine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ensifentrine profile page.

DrugPatentWatch^® Generic Entry Outlook for Ohtuvayre

Ohtuvayre will be eligible for patent challenges on June 26, 2028. 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 June 25, 2044. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for OHTUVAYRE

US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	214
What excipients (inactive ingredients) are in OHTUVAYRE?	OHTUVAYRE excipients list
DailyMed Link:	OHTUVAYRE at DailyMed

Drug patent expirations by year for OHTUVAYRE

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

Generic Entry Date for OHTUVAYRE^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial NDA: 217389 Dosage: SUSPENSION;INHALATION

^*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 OHTUVAYRE

Drug Class	Phosphodiesterase 3 Inhibitor Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 3 Inhibitors Phosphodiesterase 4 Inhibitors

US Patents and Regulatory Information for OHTUVAYRE

OHTUVAYRE is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OHTUVAYRE is ⤷ Start Trial.

This potential generic entry date is based on patent ⤷ Start Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Msd	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Msd	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial		Y		⤷ Start Trial
Msd	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Msd	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Msd	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for OHTUVAYRE

When does loss-of-exclusivity occur for OHTUVAYRE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 23324461
Estimated Expiration: ⤷ Start Trial

Patent: 23362721
Estimated Expiration: ⤷ Start Trial

Patent: 24309346
Estimated Expiration: ⤷ Start Trial

Canada

Patent: 62842
Estimated Expiration: ⤷ Start Trial

Patent: 63545
Estimated Expiration: ⤷ Start Trial

Patent: 63546
Estimated Expiration: ⤷ Start Trial

Patent: 63547
Estimated Expiration: ⤷ Start Trial

China

Patent: 9816295
Estimated Expiration: ⤷ Start Trial

Patent: 9816309
Estimated Expiration: ⤷ Start Trial

Patent: 9947727
Estimated Expiration: ⤷ Start Trial

Patent: 0379670
Estimated Expiration: ⤷ Start Trial

Patent: 0787157
Estimated Expiration: ⤷ Start Trial

Patent: 1620356
Estimated Expiration: ⤷ Start Trial

European Patent Office

Patent: 68650
Estimated Expiration: ⤷ Start Trial

Patent: 68676
Estimated Expiration: ⤷ Start Trial

Patent: 68677
Estimated Expiration: ⤷ Start Trial

Patent: 68678
Patent: ENSIFENTRINE (RPL-554) POUR DIMINUTION DE FRÉQUENCE ET/OU DE GRAVITÉ D'EXACERBATIONS DE BPCO (ENSIFENTRINE (RPL-554) FOR DECREASING THE FREQUENCY AND/OR SEVERITY OF COPD EXACERBATIONS)
Estimated Expiration: ⤷ Start Trial

Patent: 04962
Patent: TRAITEMENT DE LA FIBROSE PULMONAIRE IDIOPATHIQUE AVEC DE L'ENSIFENTRINE (TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS WITH ENSIFENTRINE)
Estimated Expiration: ⤷ Start Trial

Patent: 31183
Patent: COMPOSITION PARTICULAIRE COMPRENANT DE L'ENSIFENTRINE (PARTICULATE COMPOSITION COMPRISING ENSIFETRINE)
Estimated Expiration: ⤷ Start Trial

Israel

Patent: 8666
Patent: אנסיפנטרין (rpl-554) להפחתת התדירות ו/או החומרה של החמרות מחלת ריאות חסימתית כרונית (Ensifentrine (rpl-554) for decreasing the frequency and/or severity of copd exacerbations)
Estimated Expiration: ⤷ Start Trial

Japan

Patent: 25527316
Patent: トラフ肺機能を増加させるためのエンシフェントリン（ＲＰＬ－５５４）
Estimated Expiration: ⤷ Start Trial

Patent: 25527317
Patent: 中等度の慢性閉塞性肺疾患（ＣＯＰＤ）の治療のためのエンシフェントリン（ＲＰＬ－５５４）
Estimated Expiration: ⤷ Start Trial

Patent: 25528137
Patent: ＣＯＰＤ増悪の頻度および／または重症度を減少させるためのエンシフェントリン（ＲＰＬ－５５４）
Estimated Expiration: ⤷ Start Trial

Patent: 25528141
Patent: 液体医薬組成物
Estimated Expiration: ⤷ Start Trial

Patent: 25535129
Patent: エンシフェントリンでの特発性肺線維症の治療
Estimated Expiration: ⤷ Start Trial

Patent: 26522498
Patent: エンシフェントリンを含む粒子組成物
Estimated Expiration: ⤷ Start Trial

Mexico

Patent: 25001476
Patent: ENSIFENTRINA (RPL-554) PARA DISMINUIR LA FRECUENCIA Y/O GRAVEDAD DE EXACERBACIONES DE COPD (ENSIFENTRINE (RPL-554) FOR DECREASING THE FREQUENCY AND/OR SEVERITY OF COPD EXACERBATIONS)
Estimated Expiration: ⤷ Start Trial

Patent: 25015534
Patent: COMPOSICION PARTICULADA QUE COMPRENDE ENSIFETRINA (PARTICULATE COMPOSITION COMPRISING ENSIFETRINE)
Estimated Expiration: ⤷ Start Trial

South Korea

Patent: 250040090
Patent: 액상 약제학적 조성물
Estimated Expiration: ⤷ Start Trial

Patent: 250047802
Patent: 중등도 만성 폐쇄성 폐질환(COPD) 치료를 위한 엔시펜트린(RPL-554)
Estimated Expiration: ⤷ Start Trial

Patent: 250048092
Patent: 만성 폐쇄성 폐질환 악화 빈도 및/또는 중증도 감소를 위한 엔시펜트린(RPL-554)
Estimated Expiration: ⤷ Start Trial

Patent: 250048093
Patent: 최저 폐 기능 향상을 위한 엔시펜트린(RPL-554)
Estimated Expiration: ⤷ Start Trial

Patent: 250086769
Patent: 엔시펜트린을 이용한 특발성 폐섬유증 치료
Estimated Expiration: ⤷ Start Trial

Patent: 260036547
Patent: 엔시펜트린을 포함하는 입자상 조성물
Estimated Expiration: ⤷ Start Trial

Taiwan

Patent: 2506117
Patent: Particulate composition
Estimated Expiration: ⤷ Start Trial

United Kingdom

Patent: 2309605
Estimated Expiration: ⤷ Start Trial

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

See the table below for additional patents covering OHTUVAYRE around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	2015316592		⤷ Start Trial
Australia	2018286571		⤷ Start Trial
Australia	2020203081		⤷ Start Trial
Brazil	112017005050		⤷ Start Trial
Canada	2959943		⤷ Start Trial
China	106794157		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration