Mylan Company Profile

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MYLAN has seven hundred and forty-three approved drugs.

There are forty-seven US patents protecting MYLAN drugs. There are forty-two tentative approvals on MYLAN drugs.

There are three hundred and three patent family members on MYLAN drugs in forty-two countries and one thousand one hundred and ten supplementary protection certificates in eighteen countries.

International Patents:	303
US Patents:	47
Tradenames:	517
Ingredients:	467
NDAs:	743
Patent Litigation for Mylan:	See patent lawsuits for Mylan
PTAB Cases with Mylan as petitioner:	See PTAB cases with Mylan as petitioner

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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
Mylan Labs Ltd	LEVOFLOXACIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	204899-001	Dec 8, 2017		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan	ETODOLAC	etodolac	TABLET;ORAL	075104-001	Feb 6, 1998		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan	ROPINIROLE HYDROCHLORIDE	ropinirole hydrochloride	TABLET;ORAL	078881-005	May 5, 2008		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
>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
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-001	Nov 19, 1996	5,773,020	⤷ Try a Trial
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-001	Nov 19, 1996	5,474,535	⤷ Try a Trial
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-001	Nov 19, 1996	5,242,391	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	for Injection	1 mg/vial, 2 mg/vial and 5 mg/vial	➤ Subscribe	2013-12-27
➤ Subscribe	Injection (Auto-injector)	0.15 mg/0.3 mL and 0.3 mg/0.3 mL	➤ Subscribe	2008-11-21
➤ Subscribe	Ophthalmic Solution	0.05%	➤ Subscribe	2006-12-13
➤ Subscribe	Inhalation Solution	300 mg/5 mL	➤ Subscribe	2009-06-29
➤ Subscribe	Nasal Spray	137 mcg/50 mcg per spray	➤ Subscribe	2014-06-13
➤ Subscribe	Foam	0.12%	➤ Subscribe	2007-08-10
➤ Subscribe	CapsulesInhalation Solution	0.02 mg/2 mL	➤ Subscribe	2009-01-21
➤ Subscribe	Delayed-release Tablets	20 mg	➤ Subscribe	2015-06-03
➤ Subscribe	for Injection	200 mcg/vial	➤ Subscribe	2015-05-01
➤ Subscribe	Injection	1 mg/mL, 50 mL vials	➤ Subscribe	2011-12-16
➤ Subscribe	Nasal Spray	0.125 mg base/spray	➤ Subscribe	2005-11-14
➤ Subscribe	Injection (Auto-injector)	0.15 mg/0.3 mL and 0.3 mg/0.3 mL	➤ Subscribe	2008-11-21
➤ Subscribe	Inhalation Solution	0.021% and 0.042%	➤ Subscribe	2005-10-19
➤ Subscribe	Nasal Spray	205.5 mcg/spray	➤ Subscribe	2011-12-15
➤ Subscribe	Foam	2%	➤ Subscribe	2009-07-30
➤ Subscribe	Sublingual Tablets	5 mg and 10 mg	➤ Subscribe	2010-04-29
➤ Subscribe	Topical Foam	0.05%	➤ Subscribe	2005-06-27
➤ Subscribe	for Injection	100 mcg/vial and 500 mcg/vial	➤ Subscribe	2015-04-14
➤ Subscribe	Injection	100 mg/mL, 2.5 mL vials	➤ Subscribe	2007-09-24

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Country	Patent Number	Estimated Expiration
Tunisia	SN04247	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2005087738	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2006002178	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	2021019	Norway	⤷ Try a Trial	PRODUCT NAME: KOMBINASJON AV FORMOTEROL; REG. NO/DATE: EU/1/20/1498 20201216
0164865	C970030	Netherlands	⤷ Try a Trial	PRODUCT NAME: IBUTILIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARD BAAR ZOUT, IN HET BIJZONDER HET FUMARAAT; NAT. REGISTRATION NO/DATE: RVG 21286 19970612; FIRST REGISTRATION: GB PL 0032/0212 19960930
1020461	300482	Netherlands	⤷ Try a Trial	PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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