Covis Company Profile

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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.

International Patents:	144
US Patents:	5
Tradenames:	12
Ingredients:	9
NDAs:	11
Patent Litigation for Covis:	See patent lawsuits for Covis

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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
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-007	Jan 2, 2008	AB	RX	Yes	Yes		⤷ Subscribe				⤷ Subscribe
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes	11,000,517	⤷ Subscribe	Y			⤷ Subscribe
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes	10,085,974	⤷ Subscribe	Y			⤷ Subscribe
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-004	Feb 2, 1995		DISCN	Yes	No		⤷ Subscribe				⤷ Subscribe
Covis	LANOXIN	digoxin	INJECTABLE;INJECTION	009330-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes		⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	10,034,867	⤷ Subscribe
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-001	Feb 2, 1995	4,703,038	⤷ Subscribe
Covis	ALTOPREV	lovastatin	TABLET, EXTENDED RELEASE;ORAL	021316-001	Jun 26, 2002	5,916,595	⤷ Subscribe
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	10,588,895	⤷ Subscribe
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	7,553,479	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169062	2012C/052	Belgium	⤷ Subscribe	PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620
1169062	C01169062/01	Switzerland	⤷ Subscribe	PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012
1169062	C300558	Netherlands	⤷ Subscribe	PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
1200431	2013/002	Ireland	⤷ Subscribe	PRODUCT NAME: ACLIDINIUM SALT WITH A PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; NAT REGISTRATION NO/DATE: EU/1/12/778/001-003 20120720; FIRST REGISTRATION NO/DATE: EU/1/12/781/001-003 20/07/2012 EUROPEAN UNION EU/1/12/778/001-003 20/07/2012 EUROPEAN UNION EU/1/12/781/001-003 20120720
1200431	SPC/GB13/006	United Kingdom	⤷ Subscribe	PRODUCT NAME: ACLIDINIUM SALT WITH PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; REGISTERED: UK EU/1/12/778/001 20120720; UK EU/1/12/778/002 20120720; UK EU/1/12/778/003 20120720; UK EU/1/12/781/001 20120720; UK EU/1/12/781/002 20120720; UK EU/1/12/781/003 20120720
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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