TRIMBOW Drug Patent Profile

When do Trimbow patents expire, and when can generic versions of Trimbow launch?

Trimbow is a drug marketed by Chiesi and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and forty-three patent family members in forty-one countries.

The generic ingredient in TRIMBOW is beclomethasone dipropionate; formoterol fumarate; glycopyrrolate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the beclomethasone dipropionate; formoterol fumarate; glycopyrrolate profile page.

DrugPatentWatch^® Generic Entry Outlook for Trimbow

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 23, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TRIMBOW

International Patents:	143
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	7
What excipients (inactive ingredients) are in TRIMBOW?	TRIMBOW excipients list
DailyMed Link:	TRIMBOW at DailyMed

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

Constraining patent/regulatory exclusivity:

10,806,701

NDA:

219622

Dosage:

AEROSOL, METERED;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.

Recent Clinical Trials for TRIMBOW

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

Sponsor	Phase
University of Alabama at Birmingham	PHASE2
National Institute of Respiratory Diseases, Mexico	PHASE4
Chiesi Farmaceutici S.p.A.	Phase 4

See all TRIMBOW clinical trials

Pharmacology for TRIMBOW

Drug Class	Anticholinergic Cholinergic Muscarinic Antagonist Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists Cholinergic Muscarinic Antagonists Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for TRIMBOW

TRIMBOW is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,806,701.

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
Chiesi	TRIMBOW	beclomethasone dipropionate; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	219622-001	May 14, 2026		RX	Yes	Yes	12,357,568		Y
Chiesi	TRIMBOW	beclomethasone dipropionate; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	219622-001	May 14, 2026		RX	Yes	Yes
Chiesi	TRIMBOW	beclomethasone dipropionate; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	219622-001	May 14, 2026		RX	Yes	Yes	10,159,645		Y

International Patents for TRIMBOW

When does loss-of-exclusivity occur for TRIMBOW?

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

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Hong Kong

Japan

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Ukraine

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 TRIMBOW around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	079726
Argentina	115897
Australia	2010334859

Supplementary Protection Certificates for TRIMBOW

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2515855	300923	Netherlands		PRODUCT NAME: COMBINATIE VAN GLYCOPYRRONIUMBROMIDE, FORMOTEROL OF EEN ZOUT DAARVAN EN BECLOMETASONDIPROPIONAAT; REGISTRATION NO/DATE: EU/1/17/1208 20170719
2515855	PA2018001	Lithuania		PRODUCT NAME: GLIKOPIRONIO BROMIDO, FORMOTEROLIO ARBA JO DRUSKOS IR BEKLAMETAZONO DIPROPIONATO DERINYS; REGISTRATION NO/DATE: EU/1/17/1208 20170717
2515855	122018000007	Germany		PRODUCT NAME: KOMBINATION VON GLYCOPYRRONIUMBROMID, FORMOTEROL ODER EINEM SALZ DAVON UND BECLOMETASONDIPROPIONAT; REGISTRATION NO/DATE: EU/1/17/1208 20170717