Mylan Speciality Lp Company Profile

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MYLAN SPECIALITY LP has nineteen 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 sixty-nine 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	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes	8,869,794	⤷ Subscribe	Y			⤷ Subscribe
Mylan Speciality Lp	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009		DISCN	No	No	8,071,073	⤷ Subscribe	Y			⤷ Subscribe
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes	7,559,325	⤷ Subscribe	Y			⤷ Subscribe
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-004	Nov 19, 1996		DISCN	Yes	No		⤷ Subscribe				⤷ Subscribe
Mylan Speciality Lp	EPIPEN	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-001	Dec 22, 1987	AB	RX	Yes	Yes	9,586,010	⤷ Subscribe	Y			⤷ Subscribe
>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	020700-001	Nov 19, 1996	4,801,587	⤷ Subscribe
Mylan Speciality Lp	FELBATOL	felbamate	TABLET;ORAL	020189-002	Jul 29, 1993	4,978,680	⤷ Subscribe
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-004	Nov 19, 1996	5,242,391	⤷ Subscribe
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-004	Nov 19, 1996	5,886,039	⤷ Subscribe
Mylan Speciality Lp	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006	7,198,801	⤷ Subscribe
>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	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	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
1280520	C01280520/01	Switzerland	⤷ Subscribe	PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012
1380301	CA 2009 00017	Denmark	⤷ Subscribe	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
0402407	97C0005	Belgium	⤷ Subscribe	PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
2236132	C300714	Netherlands	⤷ Subscribe	PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
1453521	CA 2016 00016	Denmark	⤷ Subscribe	PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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