MYLAN SPECIALITY LP Company Profile

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MYLAN SPECIALITY LP has twenty 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	EPIPEN	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-001	Dec 22, 1987	AB	RX	Yes	Yes	9,586,010	⤷ Sign Up	Y			⤷ Sign Up
Mylan Speciality Lp	EPIPEN	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	019430-001	Dec 22, 1987	AB	RX	Yes	Yes	7,794,432	⤷ Sign Up	Y			⤷ Sign Up
Mylan Speciality Lp	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-001	Oct 15, 2008		DISCN	Yes	No	8,518,919	⤷ Sign Up				⤷ Sign Up
Mylan Speciality Lp	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009		DISCN	No	No	9,919,050	⤷ 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	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-003	Nov 19, 1996	5,242,391	⤷ Sign Up
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-002	Nov 19, 1996	5,773,020	⤷ Sign Up
Mylan Speciality Lp	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479-001	Feb 29, 1996	4,515,805	⤷ Sign Up
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009	8,512,747	⤷ 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	300 mg/5 mL	➤ Subscribe	2009-06-29
➤ Subscribe	Nasal Spray	137 mcg/50 mcg per spray	➤ Subscribe	2014-06-13
➤ 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

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006002178	⤷ Sign Up
Canada	2779633	⤷ Sign Up
Israel	216931	⤷ Sign Up
European Patent Office	2522365	⤷ Sign Up
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	1390033-7	Sweden	⤷ Sign Up	PRODUCT NAME: AZELASTIN, ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV, OCH EN FARMACEUTISKT GODTAGBAR ESTER AV FLUTIKASON; NAT. REG. NO/DATE: MTNR 47084 20130221; FIRST REG.: SK 24/0055/13-S 20130215
1519731	175 5006-2013	Slovakia	⤷ Sign Up	PRODUCT NAME: AZELASTIN ALEBO JEHO FARMACEUTICKY PRIJATE LNE SOLI A FARMACEUTICKY PRIJATEL NY ESTER FLUTIKAZONU; REGISTRATION NO/DATE: 24/0055/13-S 20130215
0770388	2009/012	Ireland	⤷ Sign Up	PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
0771217	07C0001	France	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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