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	COLYTE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	018983-010	Jan 31, 1989		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes	10,207,066	⤷ Try a Trial	Y			⤷ Try a Trial
Mylan Speciality Lp	IPRATROPIUM BROMIDE	ipratropium bromide	SOLUTION;INHALATION	074755-001	Jan 10, 1997		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-004	Nov 19, 1996		RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-002	Nov 19, 1996		RX	Yes	Yes		⤷ 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	AVC	sulfanilamide	CREAM;VAGINAL	006530-003	Jan 27, 1987		DISCN	Yes	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	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
Mylan Speciality Lp	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006	7,198,801	⤷ Try a Trial
Mylan Speciality Lp	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479-001	Feb 29, 1996	4,421,762	⤷ 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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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006002178	⤷ Try a Trial
Mexico	344036	⤷ Try a Trial
Denmark	2522365	⤷ Try a Trial
China	101098714	⤷ Try a Trial
Austria	428428	⤷ Try a Trial
South Korea	101066737	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2007061454	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	92269	Luxembourg	⤷ Try a Trial	PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
0770388	2009/012	Ireland	⤷ Try a Trial	PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
1453521	CA 2016 00016	Denmark	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1519731	132013902182575	Italy	⤷ Try a Trial	PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
1280520	C01280520/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012
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
0398460	SPC/GB04/032	United Kingdom	⤷ Try a Trial	PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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