MYLAN SPECIALITY LP Company Profile

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MYLAN SPECIALITY LP has thirty-one approved drugs.

There are twenty US patents protecting MYLAN SPECIALITY LP drugs.

There are one hundred and eighty-one patent family members on MYLAN SPECIALITY LP drugs in thirty-seven countries and seventy supplementary protection certificates in seventeen countries.

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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 Speciality Lp	LEVALBUTEROL HYDROCHLORIDE	levalbuterol hydrochloride	SOLUTION;INHALATION	077800-003	Mar 15, 2013		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan Speciality Lp	EPIPEN	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-001	Dec 22, 1987	AB	RX	Yes	Yes	8,048,035	⤷ Try a Trial	Y			⤷ Try a Trial
Mylan Speciality Lp	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006		RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Mylan Speciality Lp	COLYTE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	018983-007	Jun 12, 1987		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	AB	RX	Yes	No	8,163,723*PED	⤷ 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	DEMADEX	torsemide	TABLET;ORAL	020136-002	Aug 23, 1993	RE30633	⤷ Try a Trial
Mylan Speciality Lp	DUONEB	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	020950-001	Mar 21, 2001	6,632,842	⤷ Try a Trial
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-004	Nov 19, 1996	5,474,535	⤷ Try a Trial
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-003	Nov 19, 1996	5,773,020	⤷ Try a Trial
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	7,097,827	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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	Sublingual Tablets	5 mg and 10 mg	➤ Subscribe	2010-04-29
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	93156	Luxembourg	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1380301	CA 2009 00017	Denmark	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
0285237	95C0008	Belgium	⤷ Try a Trial	PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
1519731	PA2013023	Lithuania	⤷ Try a Trial	PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004
1453521	C201630040	Spain	⤷ Try a Trial	PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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