Mylan Company Profile

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MYLAN has seven hundred and thirty-eight approved drugs.

There are forty-five US patents protecting MYLAN drugs. There are forty-three 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 forty-six supplementary protection certificates in eighteen countries.

International Patents:	303
US Patents:	45
Tradenames:	515
Ingredients:	465
NDAs:	738
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 Institutional	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065371-002	Nov 28, 2007		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan	TIMOLOL MALEATE	timolol maleate	TABLET;ORAL	072668-002	Jun 8, 1990	AB	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan	FENOFIBRATE	fenofibrate	TABLET;ORAL	076520-002	Dec 29, 2005		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan Pharms Inc	LITHIUM CARBONATE	lithium carbonate	TABLET, EXTENDED RELEASE;ORAL	202288-001	Jun 29, 2012	AB	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	075108-001	Dec 17, 1999		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 Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	7,462,645	⤷ Try a Trial
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	RE33239	⤷ Try a Trial
Mylan Speciality Lp	AEROSPAN HFA	flunisolide	AEROSOL, METERED;INHALATION	021247-001	Jan 27, 2006	5,980,867	⤷ Try a Trial
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	5,916,893	⤷ Try a Trial
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	8,623,922	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2805723	LUC00064	Luxembourg	⤷ Try a Trial	PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
1644019	SPC/GB13/052	United Kingdom	⤷ Try a Trial	PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; REGISTERED: UK PL08081/0050-2 20130201; UK PL08081/0062-4 20130201
0403159	14/2000	Austria	⤷ Try a Trial	PRODUCT NAME: EPROSARTAN, AUCH IN FORM PHARMAZEUTISCH VERTRAEGLICHER SALZE WIE EPROSARTAN MESYLAT; NAT. REGISTRATION NO/DATE: 1-22115, 1-22114, 1-22117 19970930; FIRST REGISTRATION: DE 39573.00.00 - 39573.02.00 19970417
0564409	C00564409/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
0496835	SPC/GB96/053	United Kingdom	⤷ Try a Trial	PRODUCT NAME: DOXORUBICIN SULPHATE; REGISTERED: UK EU/1/96/011/001 19960621; UK EU/1/96/011/002 19960621
>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.