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Last Updated: March 29, 2024

Mylan Company Profile


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Summary for Mylan
International Patents:303
US Patents:46
Tradenames:519
Ingredients:469
NDAs:743
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 ZAGAM sparfloxacin TABLET;ORAL 020677-001 Dec 19, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mylan OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 202285-004 May 12, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd NORETHINDRONE norethindrone TABLET;ORAL-28 200980-001 Jun 12, 2013 AB2 RX No Yes ⤷  Try a Trial ⤷  Try a Trial
Mylan Pharms Inc FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202579-001 Jan 10, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mylan ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079014-001 Jul 18, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mylan OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 205070-002 Jun 29, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mylan Pharms Inc FENOFIBRATE fenofibrate TABLET;ORAL 204475-002 Jun 23, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Mylan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-004 Aug 23, 1993 RE30633 ⤷  Try a Trial
Mylan Speciality Lp DUONEB albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 020950-001 Mar 21, 2001 6,632,842 ⤷  Try a Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 8,715,623 ⤷  Try a Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 5,840,763 ⤷  Try a Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-003 Aug 23, 1993 4,018,929 ⤷  Try a Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-001 Aug 23, 1993 RE30633 ⤷  Try a Trial
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 9,901,585 ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for MYLAN drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Nasal Spray 0.125 mg base/spray ➤ Subscribe 2005-11-14
➤ Subscribe Injection (Auto-injector) 0.15 mg/0.3 mL and 0.3 mg/0.3 mL ➤ Subscribe 2008-11-21
➤ Subscribe Inhalation Solution 0.021% and 0.042% ➤ Subscribe 2005-10-19
➤ Subscribe Nasal Spray 205.5 mcg/spray ➤ Subscribe 2011-12-15
➤ Subscribe Foam 2% ➤ Subscribe 2009-07-30
➤ Subscribe Sublingual Tablets 5 mg and 10 mg ➤ Subscribe 2010-04-29
➤ Subscribe Topical Foam 0.05% ➤ Subscribe 2005-06-27
➤ Subscribe for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe Injection 100 mg/mL, 2.5 mL vials ➤ Subscribe 2007-09-24
➤ Subscribe for Injection 1 mg/vial, 2 mg/vial and 5 mg/vial ➤ Subscribe 2013-12-27
➤ Subscribe Injection (Auto-injector) 0.15 mg/0.3 mL and 0.3 mg/0.3 mL ➤ Subscribe 2008-11-21
➤ Subscribe Ophthalmic Solution 0.05% ➤ Subscribe 2006-12-13
➤ Subscribe Inhalation Solution 300 mg/5 mL ➤ Subscribe 2009-06-29
➤ Subscribe Nasal Spray 137 mcg/50 mcg per spray ➤ Subscribe 2014-06-13
➤ Subscribe Foam 0.12% ➤ Subscribe 2007-08-10
➤ Subscribe CapsulesInhalation Solution 0.02 mg/2 mL ➤ Subscribe 2009-01-21
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01

Supplementary Protection Certificates for Mylan Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049506 2015C/058 Belgium ⤷  Try a Trial PRODUCT NAME: COBICISTAT; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001
0496835 SPC/GB96/053 United Kingdom ⤷  Try a Trial PRODUCT NAME: DOXORUBICIN SULPHATE; REGISTERED: UK EU/1/96/011/001 19960621; UK EU/1/96/011/002 19960621
1948158 2016C/026 Belgium ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUT COMPLEX, I.E. TRINATRIUM (3-((1S,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONIL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2-(TETRAZOL-5-YLATE)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT)HEMIPENTAHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
0328535 96C0021 Belgium ⤷  Try a Trial PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209
0613371 SPC/GB02/033 United Kingdom ⤷  Try a Trial PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
2487166 93354 Luxembourg ⤷  Try a Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI ET ALAFENAMIDE DE TENOFOVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE D'ALAFENAMIDE DE TENOFOVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1061
0788511 SPC/GB08/036 United Kingdom ⤷  Try a Trial PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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