UPNEEQ Drug Patent Profile

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

Upneeq is a drug marketed by Rvl Pharms and is included in one NDA. There are twelve patents protecting this drug.

This drug has fifty-seven patent family members in twenty-nine countries.

The generic ingredient in UPNEEQ is oxymetazoline hydrochloride. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the oxymetazoline hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Upneeq

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 16, 2039. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for UPNEEQ

International Patents:	57
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	2
Patent Applications:	2,169
What excipients (inactive ingredients) are in UPNEEQ?	UPNEEQ excipients list
DailyMed Link:	UPNEEQ at DailyMed

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

Constraining patent/regulatory exclusivity:

10,814,001

NDA:

212520

Dosage:

SOLUTION/DROPS;OPHTHALMIC

^*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 UPNEEQ

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

Sponsor	Phase
Milton S. Hershey Medical Center	Phase 3
University of Miami	Phase 4

See all UPNEEQ clinical trials

Pharmacology for UPNEEQ

Drug Class	Vasoconstrictor
Physiological Effect	Increased Sympathetic Activity Vasoconstriction

US Patents and Regulatory Information for UPNEEQ

UPNEEQ is protected by twelve US patents.

This potential generic entry date is based on patent 10,814,001.

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
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	11,324,722
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	10,912,765
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	10,940,138
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	11,103,482		Y
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	10,898,573		Y
Rvl Pharms	UPNEEQ	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	212520-001	Jul 8, 2020		RX	Yes	Yes	8,357,714

International Patents for UPNEEQ

When does loss-of-exclusivity occur for UPNEEQ?

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

Australia

Brazil

Canada

Chile

China

Colombia

European Patent Office

Israel

Japan

Mexico

Morocco

New Zealand

Peru

Singapore

South Africa

South Korea

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 UPNEEQ around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2020268329
Brazil	112021022404
Canada	3139443
Chile	2021002918
China	111888326
China	117045596

DrugChatter Q&A for UPNEEQ

Will insurance cover upneeq?
Is there a generic for upneeq?
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