Mylan Speciality Lp Company Profile

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MYLAN SPECIALITY LP has thirty-four approved drugs.

There are twenty-seven US patents protecting MYLAN SPECIALITY LP drugs.

There are two hundred and forty-eight patent family members on MYLAN SPECIALITY LP drugs in thirty-eight countries and sixty-seven 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		⤷ Sign Up				⤷ Sign Up
Mylan Speciality Lp	ACCUNEB	albuterol sulfate	SOLUTION;INHALATION	020949-001	Apr 30, 2001		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	AB	RX	Yes	Yes	9,901,585	⤷ Sign Up	Y			⤷ Sign Up
>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	020136-004	Aug 23, 1993	4,822,807	⤷ Sign Up
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-004	Nov 19, 1996	4,801,587	⤷ Sign Up
Mylan Speciality Lp	FELBATOL	felbamate	TABLET;ORAL	020189-001	Jul 29, 1993	5,082,861	⤷ Sign Up
>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
1214076	SZ 49/2008	Austria	⤷ Sign Up	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1280520	14/2015	Austria	⤷ Sign Up	PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1519731	132013902182575	Italy	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description