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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
McKesson
Daiichi Sankyo
Cantor Fitzgerald
Johnson and Johnson
US Department of Justice
US Army
Teva
Medtronic

Generated: May 27, 2018

DrugPatentWatch Database Preview

Mylan Company Profile

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Summary for Mylan
International Patents:463
US Patents:39
Tradenames:575
Ingredients:515
NDAs:876
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 VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078789-003 Jun 1, 2011 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Mylan CHLOROTHIAZIDE chlorothiazide TABLET;ORAL 084217-002 Approved Prior to Jan 1, 1982 RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial
Mylan QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; quinapril hydrochloride TABLET;ORAL 077093-002 Mar 28, 2005 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Technologies ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 075182-001 Feb 24, 2000 AB2 RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Mylan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-001 Nov 19, 1996 5,886,039 ➤ Try a Free Trial
Mylan Speciality Lp ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114-001 Nov 1, 1996 5,164,194*PED ➤ Try a Free Trial
Mylan Speciality Lp GASTROCROM cromolyn sodium CONCENTRATE;ORAL 020479-001 Feb 29, 1996 4,421,762 ➤ Try a Free Trial
Mylan Pharms Inc AVITA tretinoin CREAM;TOPICAL 020404-003 Jan 14, 1997 4,971,800 ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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

Non-Orange Book US 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
8,318,709 Combination of azelastine and mometasone for nasal administration ➤ Try a Free Trial
7,387,788 Pharmaceutical compositions of nicotine and methods of use thereof ➤ Try a Free Trial
8,586,066 Topical antifungal composition ➤ Try a Free Trial
6,388,074 Process for the preparation of purine derivatives ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Mylan Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1920764/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: TRAVOPROST; REGISTRATION NUMBER/DATE: SWISSMEDIC 55910 22.05.2002
2008 00029 Denmark ➤ Try a Free Trial PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
C/GB96/059 United Kingdom ➤ Try a Free Trial PRODUCT NAME: REMIFENTANIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT, INCLUDING REMIFENTANIL HYDROCHLORIDE; REGISTERED: DE 36335.00.00 19960517; DE 36335.01.00 19960517; DE 36335.02.00 19960517; UK 14213/0002 19961030; UK 14213/0003 19961030; UK 14213/0004 19961030
90027-7 Sweden ➤ Try a Free Trial PRODUCT NAME: MONTELUKAST, R-(E)-1-1-3-2-(7-KLOR-2KINOLINYL)-ETENYL)-FENYL)-3-(2-(1-HYDROXI-1-METYLETYL)-FENYL)-PROPYL)-TIO)METYL)-CYKLOPROPANAETTIKSYRA, ELLER ETT FARMACEUTISKT GODDTAGBART SALT DAERAV, FOERETRAEDESVIS NATRIUMSALTET; NAT REG./DATE: 13944 19880111; FIRST REG.: FI EG 12766 19970825
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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

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

Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Medtronic
Express Scripts
Fish and Richardson
Cantor Fitzgerald
Chinese Patent Office
Teva
Federal Trade Commission
Fuji

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.