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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo
UBS
Farmers Insurance
Accenture
Citi
Medtronic
Moodys
Julphar
Teva

Generated: December 11, 2017

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Mylan Pharms Inc Company Profile

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

MYLAN PHARMS INC has two hundred and forty approved drugs.

There are twelve US patents protecting MYLAN PHARMS INC drugs. There are twenty-nine tentative approvals on MYLAN PHARMS INC drugs.

There are two hundred and twenty patent family members on MYLAN PHARMS INC drugs in forty countries and three hundred and fifty-five supplementary protection certificates in thirteen countries.

Summary for Mylan Pharms Inc

International Patents:220
US Patents:12
Tradenames:196
Ingredients:186
NDAs:240
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms IncTRAMADOL HYDROCHLORIDEtramadol hydrochlorideTABLET, EXTENDED RELEASE;ORAL205257-002Dec 22, 2015AB1RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncALPRAZOLAMalprazolamTABLET;ORAL074046-002Oct 19, 1993ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncMODAFINILmodafinilTABLET;ORAL076594-001Jul 16, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncBENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEbenazepril hydrochloride; hydrochlorothiazideTABLET;ORAL076612-001Feb 11, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncFENOFIBRIC ACIDcholine fenofibrateCAPSULE, DELAYED RELEASE;ORAL200913-001Mar 25, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncLAMIVUDINElamivudineTABLET;ORAL204528-002Mar 4, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncZIPRASIDONE HYDROCHLORIDEziprasidone hydrochlorideCAPSULE;ORAL202395-001Oct 10, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncDEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateTABLET;ORAL206721-002Nov 10, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncNAPROXENnaproxenTABLET, DELAYED RELEASE;ORAL075390-001Apr 19, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncFOSAMPRENAVIR CALCIUMfosamprenavir calciumTABLET;ORAL204060-001Apr 15, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Mylan Pharms Inc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Pharms IncZONALONdoxepin hydrochlorideCREAM;TOPICAL020126-001Apr 1, 1994► Subscribe► Subscribe
Mylan Pharms IncDENAVIRpenciclovirCREAM;TOPICAL020629-001Sep 24, 1996► Subscribe► Subscribe
Mylan Pharms IncMAXZIDEhydrochlorothiazide; triamtereneTABLET;ORAL019129-001Oct 22, 1984► Subscribe► Subscribe
Mylan Pharms IncDENAVIRpenciclovirCREAM;TOPICAL020629-001Sep 24, 1996► Subscribe► Subscribe
Mylan Pharms IncLUXIQbetamethasone valerateAEROSOL, FOAM;TOPICAL020934-001Feb 28, 1999► Subscribe► Subscribe
Mylan Pharms IncMAXZIDE-25hydrochlorothiazide; triamtereneTABLET;ORAL019129-003May 13, 1988► Subscribe► Subscribe
Mylan Pharms IncZOVIRAXacyclovirTABLET;ORAL020089-002Apr 30, 1991► Subscribe► Subscribe
Mylan Pharms IncDENAVIRpenciclovirCREAM;TOPICAL020629-001Sep 24, 1996► Subscribe► Subscribe
Mylan Pharms IncDENAVIRpenciclovirCREAM;TOPICAL020629-001Sep 24, 1996► Subscribe► Subscribe
Mylan Pharms IncZOVIRAXacyclovirTABLET;ORAL020089-001Apr 30, 1991► Subscribe► Subscribe
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Paragraph IV activity for MYLAN PHARMS INC drugs

Drugname Dosage Strength Tradename Submissiondate
ketoconazoleFoam2%EXTINA7/30/2009
betamethasone valerateFoam0.12%LUXIQ8/10/2007
clobetasol propionateTopical Foam0.05%OLUX6/27/2005

Non-Orange Book Patents for Mylan Pharms Inc

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
8,586,008Pharmaceutical foam► Subscribe
6,388,074 Process for the preparation of purine derivatives► Subscribe
6,126,920 Method of treating a skin disease with a corticosteroid-containing pharmaceutical composition► Subscribe
5,075,445 Guanine derivatives► Subscribe
9,492,384Microemulsion and sub-micron emulsion process and compositions► Subscribe
6,573,378 Antiviral guanine derivatives► Subscribe
9,486,394Pharmaceutical foam► Subscribe
8,263,580Vitamin formulation► Subscribe
8,449,867Microemulsion and sub-micron emulsion process and compositions► Subscribe
6,187,922 Process for the preparation of purine 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 Pharms Inc Drugs

Country Document Number Estimated Expiration
Poland322088► Subscribe
Spain2637956► Subscribe
United Kingdom9001886► Subscribe
Norway167572► Subscribe
European Patent Office1024792► Subscribe
Denmark0813413► Subscribe
European Patent Office1872776► Subscribe
AustraliaPP121798► Subscribe
South Africa8507149► Subscribe
European Patent Office2289512► 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 Pharms Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1999Austria► SubscribePRODUCT NAME: ''SILDENAFIL'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, EINSCHLIESSLICH DES CITRATS; NAT. REGISTRATION NO/DATE: EU/1/98/077/001 - EU/1/98/077/012 19980914; FIRST REGISTRATION: LI 54642 01-54642 03 19980622
91023-9Sweden► SubscribePRODUCT NAME: ROSUVASTATIN
C/GB98/027United Kingdom► SubscribePRODUCT NAME: TOLTERODINE OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: SE 13475 19970905; SE 13476 19970905; UK 00032/0222 19980203; UK 00032/0223 19980203
00540Netherlands► SubscribePRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EU/1/01/199/001-002 20011127
330Luxembourg► SubscribeCERTIFICATE TITLE: UNE COMBINAISON D'OLMESARTAN MEDOXOMIL, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET D'HYDROCHLOROTHIAZIDE (OLMETEC PLUS)
/2001Austria► SubscribePRODUCT NAME: ELETRIPTAN UND DIE PHARMAZEUTISCH VERTRAEGLICHEN SALZE DAVON, EINSCHLIESSLICH DES HYDROBROMIDS; NAT. REGISTRATION NO/DATE: 1-24155 20010801; FIRST REGISTRATION: LI 55218 01, 55218 02 20001214
C/GB00/035United Kingdom► SubscribePRODUCT NAME: EFAVIRENZ, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH IKS-54 908 01 19981120; CH IKS-54 908 02 19981120; CH IKS-54 908 03 19981120; UK EU/1/99/110/001 19990528; UK EU/1/99/110/002 19990528; UK EU/1/99/110/003 19990528; UK EU/1/99/110/004 19990528; UK EU/1/99/111/001 19990528; UK EU/1/99/111/002 19990528; UK EU/1/99/111/003 19990528; UK EU/1/99/111/004 19990528
C0036Belgium► SubscribePRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001
2015 00004Denmark► SubscribePRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
2013 00001Denmark► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
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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:

McKinsey
Argus Health
Merck
Julphar
UBS
US Department of Justice
Cipla
Deloitte
Dow
AstraZeneca

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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