ORAVIG Drug Patent Profile

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

Oravig is a drug marketed by Galt Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has twenty-four patent family members in fourteen countries.

The generic ingredient in ORAVIG is miconazole. There are twenty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the miconazole profile page.

DrugPatentWatch^® Generic Entry Outlook for Oravig

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 11, 2022. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ORAVIG

International Patents:	24
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Patent Applications:	4,012
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ORAVIG
What excipients (inactive ingredients) are in ORAVIG?	ORAVIG excipients list
DailyMed Link:	ORAVIG at DailyMed

See drug prices for ORAVIG

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for ORAVIG

NDA:

022404

Dosage:

TABLET;BUCCAL

^*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 ORAVIG

Drug Class

Azole Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for ORAVIG

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07AC	Imidazole derivatives
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J02AB	Imidazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ORAVIG

ORAVIG is protected by three US patents.

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

Patents protecting ORAVIG

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010		RX	Yes	Yes
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010		RX	Yes	Yes			Y
Galt Pharms	ORAVIG	miconazole	TABLET;BUCCAL	022404-001	Apr 16, 2010		RX	Yes	Yes			Y

International Patents for ORAVIG

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

Country	Patent Number	Title	Estimated Expiration
Israel	159842	SUSTAINED-RELEASE THERAPEUTIC BIOADHESIVE SYSTEMS
Cyprus	1107828
European Patent Office	1792610	Systèmes thérapeutiques bioadhésifs à libération prolongée (Sustained release bioadhesive therapeutic systems)