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-one 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	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-004	Nov 19, 1996		RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Mylan Speciality Lp	COLYTE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	018983-005	Oct 26, 1984		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Mylan Speciality Lp	LUFYLLIN	dyphylline	TABLET;ORAL	084566-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-002	Mar 13, 2009	AB	RX	Yes	Yes	9,265,720	⤷ Sign Up				⤷ 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	020700-004	Nov 19, 1996	5,242,391	⤷ Sign Up
Mylan Speciality Lp	ACCUNEB	albuterol sulfate	SOLUTION;INHALATION	020949-002	Apr 30, 2001	6,702,997	⤷ Sign Up
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	RE33239	⤷ Sign Up
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	8,349,294	⤷ 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
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
0334429	97C0002	Belgium	⤷ Sign Up	PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1453521	15C0050	France	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1519731	CA 2013 00023	Denmark	⤷ Sign Up	PRODUCT NAME: AZELASTIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG EN FARMACEUTISK ACCEPTABEL ESTER AF FLUTICASON, HERUNDER AZELASTIN HYDROCHLORID OG FLUTICASON PROPIONAT; NAT. REG. NO/DATE: MT49785 20130219; FIRST REG. NO/DATE: SK 24/0055/13-S 20130215
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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