Mylan Company Profile

What is the competitive landscape for MYLAN, and when can generic versions of MYLAN drugs launch?

MYLAN has seven hundred and thirty-six 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-seven supplementary protection certificates in eighteen countries.

Summary for Mylan

International Patents:	303
US Patents:	45
Tradenames:	513
Ingredients:	463
NDAs:	736
Patent Litigation for Mylan:	See patent lawsuits for Mylan
PTAB Cases with Mylan as petitioner:	See PTAB cases with Mylan as petitioner

Drugs and US Patents for Mylan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	206240-004	Sep 19, 2018		DISCN	No	No
Mylan Institutional	MEFOXIN IN PLASTIC CONTAINER	cefoxitin sodium	INJECTABLE;INJECTION	063182-001	Jan 25, 1993		DISCN	No	No
Mylan Institutional	DURACLON	clonidine hydrochloride	INJECTABLE;INJECTION	020615-002	Apr 27, 1999		DISCN	Yes	No
Mylan Pharms Inc	FAMOTIDINE	famotidine	TABLET;ORAL	075457-002	Apr 18, 2001		DISCN	No	No
Mylan Speciality Lp	IPRATROPIUM BROMIDE	ipratropium bromide	SOLUTION;INHALATION	074755-001	Jan 10, 1997		DISCN	No	No
Mylan Labs Ltd	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	206607-001	Aug 30, 2017	AP	RX	No	Yes
Mylan	CANDESARTAN CILEXETIL	candesartan cilexetil	TABLET;ORAL	078702-001	May 3, 2013	AB	RX	No	No

Expired US Patents for Mylan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	9,421,166
Mylan Speciality Lp	DEMADEX	torsemide	TABLET;ORAL	020136-004	Aug 23, 1993	4,822,807
Mylan Speciality Lp	DEMADEX	torsemide	TABLET;ORAL	020136-004	Aug 23, 1993	RE30633
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	6,667,344
Mylan Institutional	ULTIVA	remifentanil hydrochloride	INJECTABLE;INJECTION	020630-001	Jul 12, 1996	5,866,591*PED
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	7,368,102
Mylan Speciality Lp	DEMADEX	torsemide	TABLET;ORAL	020136-002	Aug 23, 1993	4,822,807

Paragraph IV (Patent) Challenges for MYLAN drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-release Tablets	20 mg		2015-06-03
	for Injection	200 mcg/vial		2015-05-01
	Injection	1 mg/mL, 50 mL vials		2011-12-16
	Nasal Spray	0.125 mg base/spray		2005-11-14
	Injection (Auto-injector)	0.15 mg/0.3 mL and 0.3 mg/0.3 mL		2008-11-21
	Inhalation Solution	0.021% and 0.042%		2005-10-19
	Nasal Spray	205.5 mcg/spray		2011-12-15
	Foam	2%		2009-07-30
	Sublingual Tablets	5 mg and 10 mg		2010-04-29
	Topical Foam	0.05%		2005-06-27
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	for Injection	1 mg/vial, 2 mg/vial and 5 mg/vial		2013-12-27
	Injection (Auto-injector)	0.15 mg/0.3 mL and 0.3 mg/0.3 mL		2008-11-21
	Ophthalmic Solution	0.05%		2006-12-13
	Inhalation Solution	300 mg/5 mL		2009-06-29
	Nasal Spray	137 mcg/50 mcg per spray		2014-06-13
	Foam	0.12%		2007-08-10
	CapsulesInhalation Solution	0.02 mg/2 mL		2009-01-21

International Patents for Mylan Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	1796636
Spain	2399279
Portugal	2522365
Japan	4943838
Cyprus	1117075
Lithuania	2522365
Australia	2005309657

Supplementary Protection Certificates for Mylan Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	CA 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
1606261	C 2010 014	Romania		PRODUCT NAME: ROFLUMILAST; NATIONAL AUTHORISATION NUMBER: RO EU/1/10/636/001, RO EU/1/10/636/002, RO EU/1/10/636/003; DATE OF NATIONAL AUTHORISATION: 20100705; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/10/636/001, EMEA EU/1/10/636/002, EMEA EU/1/10/636/003; DATE OF FIRST AUTHORISATION IN EEA: 20100705
1827461	1890010-0	Sweden		PRODUCT NAME: CLADRIBINE; REG. NO/DATE: EU/1/17/1212 20170824
2435024	122021000026	Germany		PRODUCT NAME: GLYCOPYRROLAT MIT FORMOTEROL MIT BUDESONID, ODER SALZE, ESTER, SOLVATE, ENANTIOMERE UND MISCHUNGEN VON ENANTIOMEREN DERSELBEN; REGISTRATION NO/DATE: EU/1/20/1498 20201209
1427415	11C0042	France		PRODUCT NAME: APIXABAN, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/691/001 20110520
1912999	2014/058	Ireland		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
1948158	2016C/026	Belgium		PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUT COMPLEX, I.E. TRINATRIUM (3-((1S,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONIL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2-(TETRAZOL-5-YLATE)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT)HEMIPENTAHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Mylan
• Mylan Asi
• Mylan Institutional
• Mylan Ireland Ltd
• Mylan Labs
• Mylan Labs Ltd
• Mylan Pharms Inc