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-five 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 Technologies	FENTANYL-37	fentanyl	FILM, EXTENDED RELEASE;TRANSDERMAL	076258-006	Dec 29, 2014	AB	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan	ETIDRONATE DISODIUM	etidronate disodium	TABLET;ORAL	075800-001	Jan 24, 2003		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan Pharms Inc	CLONAZEPAM	clonazepam	TABLET;ORAL	074940-001	Oct 30, 1997		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan Labs Ltd	NORGESTIMATE AND ETHINYL ESTRADIOL	ethinyl estradiol; norgestimate	TABLET;ORAL-28	202132-001	Sep 9, 2015		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	075124-003	Mar 18, 1998		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	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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0273277	C960024	Netherlands	⤷ Try a Trial	PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 - EU/1/96/009/009 19960508
2380576	20C1048	France	⤷ Try a Trial	PRODUCT NAME: SEL DE SODIUM DE L'ACIDE DESOXYCHOLIQUE; NAT. REGISTRATION NO/DATE: NL46299 20180810; FIRST REGISTRATION: IS - IS/1/16/071/01 20160729
0961612	CA 2009 00036	Denmark	⤷ Try a Trial	PRODUCT NAME: PACLITAXELALBUMIN
1663240	CA 2016 00064	Denmark	⤷ Try a Trial	PRODUCT NAME: KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, EMTRICITABIN OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
0961612	C00961612/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
>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.