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Serving leading biopharmaceutical companies globally:

Covington
McKinsey
Queensland Health
Deloitte
Chubb
UBS
Cipla
Argus Health
Harvard Business School
Farmers Insurance

Generated: October 21, 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 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-four patent family members on MYLAN drugs in forty-eight countries and five hundred and thirty-seven supplementary protection certificates in fifteen countries.

Summary for Applicant: Mylan

International Patents:494
US Patents:37
Tradenames:551
Ingredients:493
NDAs:830
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
fluconazole
INJECTABLE;INJECTION076889-002Mar 25, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
PINDOLOL
pindolol
TABLET;ORAL074019-001Sep 3, 1992ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL202742-001Oct 30, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
CHLORPROPAMIDE
chlorpropamide
TABLET;ORAL088549-001Jun 1, 1984ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
LAMOTRIGINE
lamotrigine
TABLET;ORAL078443-001Feb 11, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride
TABLET;ORAL091176-002Jun 7, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
VALSARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; valsartan
TABLET;ORAL078020-003Sep 21, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
ALBUTEROL SULFATE
albuterol sulfate
TABLET;ORAL072894-001Jan 17, 1991ABRXNoYes► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
RISPERIDONE
risperidone
TABLET, ORALLY DISINTEGRATING;ORAL091537-001Mar 30, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
IMIPRAMINE PAMOATE
imipramine pamoate
CAPSULE;ORAL202338-003Jun 28, 2013DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Mylan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-004Nov 19, 1996► Subscribe► Subscribe
Mylan Speciality Lp
DEMADEX
torsemide
TABLET;ORAL020136-004Aug 23, 1993► Subscribe► Subscribe
Mylan Speciality Lp
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-004Nov 19, 1996► Subscribe► Subscribe
Mylan Institutional
ULTIVA
remifentanil hydrochloride
INJECTABLE;INJECTION020630-002Jul 12, 1996► Subscribe► Subscribe
Mylan Speciality Lp
DEMADEX
torsemide
TABLET;ORAL020136-003Aug 23, 1993► Subscribe► Subscribe
Mylan Speciality Lp
CESAMET
nabilone
CAPSULE;ORAL018677-001Dec 26, 1985► Subscribe► Subscribe
Mylan Pharms Inc
AVITA
tretinoin
CREAM;TOPICAL020404-003Jan 14, 1997► Subscribe► Subscribe
Mylan Ireland Ltd
ARIXTRA
fondaparinux sodium
INJECTABLE;SUBCUTANEOUS021345-001Dec 7, 2001► Subscribe► Subscribe
Mylan Speciality Lp
CESAMET
nabilone
CAPSULE;ORAL018677-001Dec 26, 1985► Subscribe► Subscribe
Mylan Speciality Lp
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-004Nov 19, 1996► Subscribe► Subscribe
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Paragraph IV activity for MYLAN drugs

Drugname Dosage Strength Tradename Submissiondate
omeprazole
Delayed-release Tablets20 mg
OMEPRAZOLE
6/3/2015
levothyroxine sodium
for Injection200 mcg/vial
LEVOTHYROXINE SODIUM
5/1/2015
levothyroxine sodium
for Injection100 mcg/vial and 500 mcg/vial
LEVOTHYROXINE SODIUM
4/14/2015
azelastine hydrochloride and fluticasone propionate
Nasal Spray137 mcg/50 mcg per spray
DYMISTA
6/13/2014
remifentanil hydrochloride
for Injection1 mg/vial, 2 mg/vial and 5 mg/vial
ULTIVA
12/27/2013
argatroban in sodium chloride
Injection1 mg/mL, 50 mL vials
ARGATROBAN
12/16/2011
azelastine hydrochloride
Nasal Spray205.5 mcg/spray
ASTEPRO
12/15/2011
zolpidem tartrate
Sublingual Tablets5 mg and 10 mg
EDLUAR
4/29/2010
ketoconazole
Foam2%
EXTINA
7/30/2009
formoterol fumarate
CapsulesInhalation Solution0.02 mg/2 mL
PERFOROMIST
1/21/2009
epinephrine
Injection (Auto-injector)0.15 mg/0.3 mL and 0.3 mg/0.3 mL
EPIPEN
11/21/2008
epinephrine
Injection (Auto-injector)0.15 mg/0.3 mL and 0.3 mg/0.3 mL
EPIPEN JR.
11/21/2008
argatroban
Injection100 mg/mL, 2.5 mL vials
ARGATROBAN
9/24/2007
betamethasone valerate
Foam0.12%
LUXIQ
8/10/2007
azelastine hydrochloride
Ophthalmic Solution0.05%
OPTIVAR
12/13/2006
azelastine hydrochloride
Nasal Spray0.125 mg base/spray
ASTELIN
11/14/2005
albuterol sulfate
Inhalation Solution0.021% and 0.042%
ACCUNEB
10/19/2005
clobetasol propionate
Topical Foam0.05%
OLUX
6/27/2005

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
8,980,309Transdermal testosterone formulation for minimizing skin residues► Subscribe
8,937,057Combination of azelastine and mometasone for nasal administration► Subscribe
5,886,215 2-acetoxymethyl-4-halo-butyl-1-yl acetates► Subscribe
7,541,385Bronchodilating .beta.-agonist compositions and methods► Subscribe
7,910,132Pharmaceutical composition for the treatment of acute disorders► Subscribe
7,749,488Pharmaceutical foam► Subscribe
5,075,445 Guanine derivatives► Subscribe
6,573,378 Antiviral guanine derivatives► Subscribe
7,335,379Transdermal pharmaceutical formulation for minimizing skin residues► Subscribe
8,980,290Transdermal compositions for anticholinergic agents► 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
European Patent Office2438910► Subscribe
European Patent Office1648406► Subscribe
HungaryE030388► Subscribe
Portugal2075000► Subscribe
World Intellectual Property Organization (WIPO)03037159► Subscribe
Norway332226► Subscribe
European Patent Office1446045► Subscribe
Slovenia2522365► Subscribe
Denmark2179759► Subscribe
BrazilPI0514806► 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
C0042Belgium► SubscribePRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
0817637/01Switzerland► SubscribePRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
C/GB02/002United Kingdom► SubscribeA SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB02/002 GRANTED TO MERCK SHARP + DOHME, CORP IN RESPECT OF THE PRODUCT CASPOFUNGIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY CASPOFUNGIN ACETATE, WHICH WAS ADVERTISED AS COMING INTO FORCE IN JOURNAL NO 5919 DATED 30 OCTOBER 2002 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, IT WILL EXPIRE ON 24 OCTOBER 2016.
C/GB08/018United Kingdom► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
C0048France► SubscribePRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
C0002Belgium► SubscribePRODUCT NAME: REPAGLINIDE; REGISTRATION NO/DATE: EU/1/98/076/001 19980817
2014 00048Denmark► SubscribePRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724
/2000Austria► SubscribePRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
00117Netherlands► SubscribePRODUCT NAME: DEXMEDETOMIDINE, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH IN FARMACEUTISCH OPZICHT AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZ ONDER DEXMEDETOMIDINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/2/02/033/001 20020830
C/GB10/012United Kingdom► SubscribePRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
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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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
Express Scripts
Chubb
Healthtrust
McKesson
Fish and Richardson
Teva
McKinsey
Merck
Accenture

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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