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	GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	206936-001	Oct 3, 2017	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan	RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	200477-002	Nov 30, 2015		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan	FOSAMPRENAVIR CALCIUM	fosamprenavir calcium	TABLET;ORAL	204060-001	Apr 15, 2016	AB	RX	No	Yes		⤷ Try a Trial				⤷ Try a Trial
Mylan Institutional	ROCURONIUM BROMIDE	rocuronium bromide	INJECTABLE;INJECTION	079199-002	Nov 26, 2008	AP	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan Ireland Ltd	MIACALCIN	calcitonin salmon	INJECTABLE;INJECTION	017808-002	Mar 29, 1991	AP	RX	Yes	Yes		⤷ 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	020700-002	Nov 19, 1996	5,886,039	⤷ Try a Trial
Mylan Spclt Viatris	DIPENTUM	olsalazine sodium	CAPSULE;ORAL	019715-001	Jul 31, 1990	4,559,330	⤷ Try a Trial
Mylan Speciality Lp	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006	7,198,801	⤷ Try a Trial
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-003	Jul 12, 1996	5,866,591*PED	⤷ Try a Trial
Mylan Speciality Lp	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006	7,470,433	⤷ 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
1532149	C300569	Netherlands	⤷ Try a Trial	PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
2487163	1790002-8	Sweden	⤷ Try a Trial	PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/15/1025, 2015-07-15
0477295	SPC/GB99/046	United Kingdom	⤷ Try a Trial	PRODUCT NAME: EPTIFIBATIDE OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: CH 54054 19970227; CH 54050 19970227; UK EU/1/99/109/001 19990701; UK EU/1/99/109/002 19990701
2435025	LUC00124	Luxembourg	⤷ Try a Trial	PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2924034	19C1025	France	⤷ Try a Trial	PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN COMBINAISON AVEC LE L0181126 AMIVUDINE EN COMBINAISON AVEC LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333 2
>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.