.

BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

► See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Deloitte
Argus Health
Farmers Insurance
US Army
Boehringer Ingelheim
Colorcon
Queensland Health
Dow
Julphar
Citi

Generated: September 22, 2017

DrugPatentWatch Database Preview

Mylan Company Profile

« Back to Dashboard

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

MYLAN has eight hundred and twenty-four 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-three patent family members on MYLAN drugs in forty-seven countries.

Summary for Applicant: Mylan

Patents:37
Tradenames:548
Ingredients:491
NDAs:824
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Institutional
AZACITIDINE
azacitidine
POWDER;IV (INFUSION), SUBCUTANEOUS204949-001Apr 28, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
NORETHINDRONE
norethindrone
TABLET;ORAL-28200980-001Jun 12, 2013AB2RXNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
PACLITAXEL
paclitaxel
INJECTABLE;INJECTION091540-001Sep 29, 2011APRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
TOBRAMYCIN SULFATE
tobramycin sulfate
INJECTABLE;INJECTION065407-001Mar 11, 2008APRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
FINASTERIDE
finasteride
TABLET;ORAL078161-001Nov 5, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
ANADROL-50
oxymetholone
TABLET;ORAL016848-001Approved Prior to Jan 1, 1982RXYesYes► Subscribe► Subscribe► Subscribe
Mylan
PROPANTHELINE BROMIDE
propantheline bromide
TABLET;ORAL083706-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION202669-001Jul 17, 2012APRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
PENICILLIN G POTASSIUM
penicillin g potassium
FOR SOLUTION;ORAL060752-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
TELMISARTAN AND HYDROCHLOROTHIAZIDE
hydrochlorothiazide; telmisartan
TABLET;ORAL091648-002Feb 25, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Mylan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Institutional
ENLON-PLUS
atropine sulfate; edrophonium chloride
INJECTABLE;INJECTION019678-001Nov 6, 1991► Subscribe► Subscribe
Mylan Speciality Lp
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-003Nov 19, 1996► Subscribe► Subscribe
Mylan Speciality Lp
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-003Nov 19, 1996► Subscribe► Subscribe
Mylan Pharms Inc
ZONALON
doxepin hydrochloride
CREAM;TOPICAL020126-001Apr 1, 1994► Subscribe► Subscribe
Mylan Speciality Lp
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-001Nov 19, 1996► Subscribe► Subscribe
Mylan Speciality Lp
CESAMET
nabilone
CAPSULE;ORAL018677-001Dec 26, 1985► Subscribe► Subscribe
Mylan Speciality Lp
DEMADEX
torsemide
TABLET;ORAL020136-002Aug 23, 1993► Subscribe► Subscribe
Mylan Speciality Lp
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-004Nov 19, 1996► Subscribe► Subscribe
Mylan Institutional
RIMSO-50
dimethyl sulfoxide
SOLUTION;INTRAVESICAL017788-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Mylan Pharms Inc
LUXIQ
betamethasone valerate
AEROSOL, FOAM;TOPICAL020934-001Feb 28, 1999► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
8,298,515Vitamin formulation► Subscribe
8,304,405Combination of azelastine and ciclesonide for nasal administration► Subscribe
6,126,920 Method of treating a skin disease with a corticosteroid-containing pharmaceutical composition► Subscribe
8,937,057Combination of azelastine and mometasone for nasal administration► Subscribe
8,629,128Vitamin formulation► Subscribe
7,473,710Bronchodilating beta-agonist compositions and methods► Subscribe
7,541,385Bronchodilating .beta.-agonist compositions and methods► Subscribe
5,075,445 Guanine derivatives► Subscribe
8,758,816Compositions comprising azelastine and methods of use thereof► Subscribe
5,886,215 2-acetoxymethyl-4-halo-butyl-1-yl acetates► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Mylan Drugs

Country Document Number Estimated Expiration
South Korea20050024362► Subscribe
Canada1339818► Subscribe
Israel181632► Subscribe
Argentina030312► Subscribe
Slovenia2311510► Subscribe
Ireland910249► Subscribe
SloveniaEP2179759► Subscribe
Canada2074503► Subscribe
Norway20011473► Subscribe
United Kingdom0213739► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Mylan Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
01C/011Belgium► SubscribePRODUCT NUMBER: PIOGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/001/150/001 20001018; FIRST REGISTRATION NO: CH 55378 01 20000927
C0011Belgium► SubscribePRODUCT NAME: RIZATRIPTAN BENZOAS EQ. RIZATRIPTAN; REGISTRATION NO/DATE: 922 IS 181 F 3 19981130; FIRST REGISTRATION: NL RVG 21815 19980211
C0045France► SubscribePRODUCT NAME: TRAVOPROST; REGISTRATION NO/DATE: EU/1/01/199/001 20011127
0810Netherlands► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIURA (3-((LS,3R)-L-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-L-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-ETHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123
C0003Belgium► SubscribePRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
C/GB01/014United Kingdom► SubscribePRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
08/016Ireland► SubscribePRODUCT NAME: A COMBINATION OF EFAVIRENZ AND EMTRICTABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
2009004Lithuania► SubscribePRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
01C/030Belgium► SubscribePRODUCT NAME: MOXIFLOXACINE CHLORHYDRATE (CORRESPONDANT A MOXIFLOXACINE); NATL. REGISTRATION NO/DATE: 187 IS 328 F 3 20010507; FIRST REGISTRATION: DE 45263.00.00 19990621
00032Netherlands► SubscribePRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Similar Applicant Names

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

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Accenture
Healthtrust
Fuji
Cerilliant
Deloitte
Harvard Business School
Baxter
Fish and Richardson
Chubb
Cipla

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot