Covis Company Profile

What is the competitive landscape for COVIS, and what generic alternatives to COVIS drugs are available?

COVIS has eleven approved drugs.

There are five US patents protecting COVIS drugs.

There are one hundred and forty-four patent family members on COVIS drugs in forty-six countries and twenty-seven supplementary protection certificates in fourteen countries.

Summary for Covis

International Patents:	144
US Patents:	5
Tradenames:	12
Ingredients:	9
NDAs:	11

Drugs and US Patents for Covis

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes	RE46417		Y	Y
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-002	Feb 2, 1995		DISCN	Yes	No
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008		RX	Yes	Yes	8,371,292
Covis	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-004	Jun 26, 2002		RX	Yes	Yes
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes	8,051,851		Y
Covis	LANOXIN PEDIATRIC	digoxin	INJECTABLE;INJECTION	009330-004	Approved Prior to Jan 1, 1982		RX	Yes	Yes

Expired US Patents for Covis

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	OMNARIS	ciclesonide	SPRAY, METERED;NASAL	022004-001	Oct 20, 2006	5,482,934
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008	5,683,677
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008	5,695,743
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-003	Jan 10, 2008	6,264,923
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-004	Feb 2, 1995	4,892,741
Covis	ALVESCO	ciclesonide	AEROSOL, METERED;INHALATION	021658-002	Jan 10, 2008	5,775,321

Paragraph IV (Patent) Challenges for COVIS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	30 mg/mL, 17 mL single-use vials		2015-12-04
	Extended-release Tablets	20 mg and 30 mg		2007-11-07
	Extended-release Tablets	40 mg		2007-06-11
	Nasal Spray	250 mcg		2012-02-13
	Extended-release Tablets	25.5 mg and 34 mg		2008-11-28
	Extended-release Tablets	8.5 mg and 17 mg		2009-03-02

International Patents for Covis Drugs

Country	Patent Number	Estimated Expiration
Hungary	E059020
South Korea	100854315
Japan	5618452
Croatia	P20140257
Japan	4030040
Slovenia	1200431

Supplementary Protection Certificates for Covis Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1200431	PA2013001,C1200431	Lithuania		PRODUCT NAME: ACLIDINII BROMIDUM; REGISTRATION NO/DATE: EU/1/12/778/001 - EU/1/12/778/003, 2012 07 20 EU/1/12/781/001 - EU/1/12/781/003 20120720
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
0124495	SPC/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
1200431	1/2013	Austria		PRODUCT NAME: ACLIDINIUMSALZ MIT EINEM PHARMAZEUTISCH ANNEHMBAREN ANION EINER MONO- ODER POLYVALENTEN SAEURE INSBESONDERE ALS ACLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/12/778/001-003 EU/1/12/781/001-003 20120720
1169062	1290043-7	Sweden		PRODUCT NAME: FERUMOXYTOL; REG. NO/DATE: EU/1/12/774/001 20120615
1200431	13C0001	France		PRODUCT NAME: SEL D'ACLIDINIUM AVEC UN ANION PHARMACEUTIQUEMENT ACCEPTABLE D'UN ACIDE MONO OU POLYVALENT, EN PARTICULIER LE BROMURE D'ACLIDINIUM; REGISTRATION NO/DATE: EU/1/12/778/001-003 20120720

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Covidien
• Covis