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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Cerilliant
Medtronic
McKesson
Baxter
Mallinckrodt
Dow
Novartis
Farmers Insurance

Generated: December 16, 2017

DrugPatentWatch Database Preview

Mylan Company Profile

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

MYLAN has eight hundred and thirty-seven approved drugs.

There are thirty-seven US patents protecting MYLAN drugs and there have been three Paragraph IV challenges on MYLAN drugs in the past three years. There are fifty-three tentative approvals on MYLAN drugs.

There are four hundred and ninety-six patent family members on MYLAN drugs in forty-eight countries and five hundred and forty-three supplementary protection certificates in fifteen countries.

Summary for Mylan

International Patents:496
US Patents:37
Tradenames:555
Ingredients:497
NDAs:837
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
MylanTAMOXIFEN CITRATEtamoxifen citrateTABLET;ORAL074732-001Feb 20, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms IncMYCOPHENOLIC ACIDmycophenolic acidTABLET, DELAYED RELEASE;ORAL091248-002Jan 8, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms IncZONISAMIDEzonisamideCAPSULE;ORAL077647-001Dec 22, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms IncIRBESARTANirbesartanTABLET;ORAL200461-003Sep 27, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
MylanQUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEhydrochlorothiazide; quinapril hydrochlorideTABLET;ORAL077093-002Mar 28, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs LtdAMIFOSTINEamifostineINJECTABLE;INJECTION204363-001Jul 17, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms IncOLMESARTAN MEDOXOMILolmesartan medoxomilTABLET;ORAL078276-001Oct 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
MylanMETHOCARBAMOLmethocarbamolTABLET;ORAL084323-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms IncRUFINAMIDErufinamideTABLET;ORAL205095-001May 16, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan SpecltPERFOROMISTformoterol fumarateSOLUTION;INHALATION022007-001May 11, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Mylan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Pharms IncZOVIRAXacyclovirCAPSULE;ORAL018828-001Jan 25, 1985► Subscribe► Subscribe
Mylan Pharms IncLUXIQbetamethasone valerateAEROSOL, FOAM;TOPICAL020934-001Feb 28, 1999► Subscribe► Subscribe
Mylan Speciality LpMUSEalprostadilSUPPOSITORY;URETHRAL020700-002Nov 19, 1996► Subscribe► Subscribe
Mylan Speciality LpFELBATOLfelbamateSUSPENSION;ORAL020189-003Jul 29, 1993► Subscribe► Subscribe
Mylan InstitutionalULTIVAremifentanil hydrochlorideINJECTABLE;INJECTION020630-001Jul 12, 1996► Subscribe► Subscribe
Mylan Pharms IncAVITAtretinoinCREAM;TOPICAL020404-003Jan 14, 1997► Subscribe► Subscribe
Mylan Speciality LpDIPENTUMolsalazine sodiumCAPSULE;ORAL019715-001Jul 31, 1990► Subscribe► Subscribe
Mylan Pharms IncVUSIONmiconazole nitrate; petrolatum, white; zinc oxideOINTMENT;TOPICAL021026-001Feb 16, 2006► Subscribe► Subscribe
Mylan Pharms IncMAXZIDEhydrochlorothiazide; triamtereneTABLET;ORAL019129-001Oct 22, 1984► Subscribe► Subscribe
Mylan Ireland LtdMIACALCINcalcitonin salmonSPRAY, METERED;NASAL020313-002Aug 17, 1995► Subscribe► Subscribe
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Paragraph IV activity for MYLAN drugs

Drugname Dosage Strength Tradename Submissiondate
omeprazoleDelayed-release Tablets20 mgOMEPRAZOLE6/3/2015
levothyroxine sodiumfor Injection200 mcg/vialLEVOTHYROXINE SODIUM5/1/2015
levothyroxine sodiumfor Injection100 mcg/vial and 500 mcg/vialLEVOTHYROXINE SODIUM4/14/2015
azelastine hydrochloride and fluticasone propionateNasal Spray137 mcg/50 mcg per sprayDYMISTA6/13/2014
remifentanil hydrochloridefor Injection1 mg/vial, 2 mg/vial and 5 mg/vialULTIVA12/27/2013
argatroban in sodium chlorideInjection1 mg/mL, 50 mL vialsARGATROBAN12/16/2011
azelastine hydrochlorideNasal Spray205.5 mcg/sprayASTEPRO12/15/2011
zolpidem tartrateSublingual Tablets5 mg and 10 mgEDLUAR4/29/2010
ketoconazoleFoam2%EXTINA7/30/2009
formoterol fumarateCapsulesInhalation Solution0.02 mg/2 mLPERFOROMIST1/21/2009
epinephrineInjection (Auto-injector)0.15 mg/0.3 mL and 0.3 mg/0.3 mLEPIPEN JR.11/21/2008
epinephrineInjection (Auto-injector)0.15 mg/0.3 mL and 0.3 mg/0.3 mLEPIPEN11/21/2008
argatrobanInjection100 mg/mL, 2.5 mL vialsARGATROBAN9/24/2007
betamethasone valerateFoam0.12%LUXIQ8/10/2007
azelastine hydrochlorideOphthalmic Solution0.05%OPTIVAR12/13/2006
azelastine hydrochlorideNasal Spray0.125 mg base/sprayASTELIN11/14/2005
albuterol sulfateInhalation Solution0.021% and 0.042%ACCUNEB10/19/2005
clobetasol propionateTopical Foam0.05%OLUX6/27/2005

Non-Orange Book Patents for Mylan

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,749,488Pharmaceutical foam► Subscribe
6,388,074 Process for the preparation of purine derivatives► Subscribe
9,486,394Pharmaceutical foam► Subscribe
9,730,890Bronchodilating beta-agonist compositions and methods► Subscribe
8,629,128Vitamin formulation► Subscribe
5,075,445 Guanine derivatives► Subscribe
7,335,379Transdermal pharmaceutical formulation for minimizing skin residues► Subscribe
8,217,082Reduced irritant enema for the treatment of inflammatory bowel disease (IBD)► Subscribe
7,404,965Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► Subscribe
6,573,378 Antiviral guanine derivatives► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Mylan Drugs

Country Document Number Estimated Expiration
United Kingdom0213739► Subscribe
Canada2629988► Subscribe
European Patent Office1323431► Subscribe
Spain2324910► Subscribe
World Intellectual Property Organization (WIPO)2008094618► Subscribe
Japan2011236250► Subscribe
European Patent Office1446045► Subscribe
Portugal1670433► Subscribe
Luxembourg92636► Subscribe
Poland322088► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Mylan Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0130025 00090Estonia► SubscribePRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
2014 00050Denmark► SubscribePRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
/2004Austria► SubscribePRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
00714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
C0002Belgium► SubscribePRODUCT NAME: REPAGLINIDE; REGISTRATION NO/DATE: EU/1/98/076/001 19980817
C0030France► SubscribePRODUCT NAME: DUTASTERIDE; NAT. REGISTRATION NO/DATE: NL 28 131 20030327; FIRST REGISTRATION: SE - 17 871 20020719
292Luxembourg► SubscribePRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
2008006,C0933372Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
00125Netherlands► SubscribePRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Covington
Cerilliant
Mallinckrodt
Cipla
Johnson and Johnson
Teva
Argus Health
US Army
Deloitte
Chinese Patent Office

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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