MYLAN Company Profile

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MYLAN has seven hundred and thirty-eight approved drugs.

There are forty-five US patents protecting MYLAN drugs. There are forty-three tentative approvals on MYLAN drugs.

There are three hundred and three patent family members on MYLAN drugs in forty-two countries and one thousand one hundred and forty-six supplementary protection certificates in eighteen countries.

International Patents:	303
US Patents:	45
Tradenames:	515
Ingredients:	465
NDAs:	738
Patent Litigation for MYLAN:	See patent lawsuits for MYLAN
PTAB Cases with MYLAN as petitioner:	See PTAB cases with MYLAN as petitioner

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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	BUPRENORPHINE HYDROCHLORIDE	buprenorphine hydrochloride	TABLET;SUBLINGUAL	201066-002	Mar 6, 2015		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan	ACEBUTOLOL HYDROCHLORIDE	acebutolol hydrochloride	CAPSULE;ORAL	074288-002	Apr 24, 1995		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan	GABAPENTIN	gabapentin	CAPSULE;ORAL	090158-003	Feb 14, 2011		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Mylan	BUSPIRONE HYDROCHLORIDE	buspirone hydrochloride	TABLET;ORAL	075467-004	Feb 28, 2002		DISCN	No	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	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007	7,553,835	⤷ Try a Trial
Mylan Speciality Lp	DEMADEX	torsemide	TABLET;ORAL	020136-004	Aug 23, 1993	RE30633	⤷ Try a Trial
Mylan	ZOVIRAX	acyclovir	TABLET;ORAL	020089-002	Apr 30, 1991	4,199,574	⤷ Try a Trial
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-003	Jul 12, 1996	5,466,700*PED	⤷ 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	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
➤ Subscribe	Foam	0.12%	➤ Subscribe	2007-08-10
➤ Subscribe	CapsulesInhalation Solution	0.02 mg/2 mL	➤ Subscribe	2009-01-21
➤ Subscribe	Delayed-release Tablets	20 mg	➤ Subscribe	2015-06-03
➤ Subscribe	for Injection	200 mcg/vial	➤ Subscribe	2015-05-01
➤ Subscribe	Injection	1 mg/mL, 50 mL vials	➤ Subscribe	2011-12-16
➤ Subscribe	Nasal Spray	0.125 mg base/spray	➤ Subscribe	2005-11-14
➤ 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	Foam	2%	➤ Subscribe	2009-07-30
➤ Subscribe	Sublingual Tablets	5 mg and 10 mg	➤ Subscribe	2010-04-29
➤ Subscribe	Topical Foam	0.05%	➤ Subscribe	2005-06-27
➤ Subscribe	for Injection	100 mcg/vial and 500 mcg/vial	➤ Subscribe	2015-04-14
➤ Subscribe	Injection	100 mg/mL, 2.5 mL vials	➤ Subscribe	2007-09-24
➤ Subscribe	for Injection	1 mg/vial, 2 mg/vial and 5 mg/vial	➤ Subscribe	2013-12-27

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	2015/071	Ireland	⤷ Try a Trial	PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
0208846	SPC/GB99/024	United Kingdom	⤷ Try a Trial	PRODUCT NAME: N-(3-(3-CYANOPYRAZOLO(1,5-A)PYRIMIDIN-7-YL)PHENYL)-N-ETHYLACETAMIDE (ZALEPLON); REGISTERED: UK EU/1/99/099/001 19990312; UK EU/1/99/099/002 19990312; UK EU/1/99/099/003 19990312; UK EU/1/99/099/004 19990312; UK EU/1/99/099/005 19990312; UK EU/1/99/099/006 19990312; UK EU/1/99/102/001 19990312; UK EU/1/99/102/002 19990312; UK EU/1/99/102/003 19990312; UK EU/1/99/102/004 19990312; UK EU/1/99/102/005 19990312; UK EU/1/99/102/006 19990312
0350733	11/2000	Austria	⤷ Try a Trial	PRODUCT NAME: MOXIFLOXACIN, DESSEN PHARMAZEUTISCH VERWENDBARE HYDRATE UND SAEUREADDITIONSSALZE, DESSEN ALKALI-ERDALKALI-SILBER- UND GUANIDINIUMSALZE, SOWIE DESSEN C1 - C4 ALKYL- ODER; NAT. REGISTRATION NO/DATE: 1-23494, 1-23495, 1-23496 20000215; FIRST REGISTRATION: DE 45263.00.00 19990621
0836511	122006000022	Germany	⤷ Try a Trial	PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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