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Last Updated: January 18, 2020

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Mylan Company Profile

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Summary for Mylan
International Patents:742
US Patents:60
Tradenames:621
Ingredients:556
NDAs:944
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 AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 086009-002 Approved Prior to Jan 1, 1982 AB RX No No   Start Trial   Start Trial
Mylan AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 086009-005 Approved Prior to Jan 1, 1982 AB RX No No   Start Trial   Start Trial
Mylan Institutional DEXRAZOXANE HYDROCHLORIDE dexrazoxane hydrochloride INJECTABLE;INJECTION 200752-002 Oct 19, 2011 AP RX No No   Start Trial   Start Trial
Mylan FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075207-001 Jan 30, 2002 DISCN No No   Start Trial   Start Trial
Mylan ACYCLOVIR acyclovir TABLET;ORAL 074976-001 Apr 13, 1998 DISCN No No   Start Trial   Start Trial
Mylan ACYCLOVIR acyclovir CAPSULE;ORAL 074727-001 Apr 22, 1997 DISCN No No   Start Trial   Start Trial
Mylan ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075472-001 Aug 22, 2000 DISCN No No   Start Trial   Start 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 MUSE alprostadil SUPPOSITORY;URETHRAL 020700-001 Nov 19, 1996 5,474,535   Start Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-002 Aug 23, 1993 4,018,929   Start Trial
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-004 Nov 19, 1996 5,773,020   Start Trial
Mylan Institutional SULFAMYLON mafenide acetate CREAM;TOPICAL 016763-001 Approved Prior to Jan 1, 1982 3,497,599   Start Trial
Mylan Speciality Lp FELBATOL felbamate SUSPENSION;ORAL 020189-003 Jul 29, 1993 5,082,861   Start Trial
Mylan OLUX clobetasol propionate AEROSOL, FOAM;TOPICAL 021142-001 May 26, 2000 6,126,920   Start Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 6,124,304   Start 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 Nasal Spray 0.125 mg base/spray ➤ Subscribe 2005-11-14
➤ 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 for Injection 100 mcg/vial and 500 mcg/vial ➤ Subscribe 2015-04-14
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
➤ Subscribe Inhalation Solution 0.021% and 0.042% ➤ Subscribe 2005-10-19
➤ Subscribe Inhalation Solution 300 mg/5 mL ➤ Subscribe 2009-06-29
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Nasal Spray 205.5 mcg/spray ➤ Subscribe 2011-12-15
➤ Subscribe Nasal Spray 137 mcg/50 mcg per spray ➤ Subscribe 2014-06-13
➤ 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 for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ 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 Sublingual Tablets 5 mg and 10 mg ➤ Subscribe 2010-04-29

Supplementary Protection Certificates for Mylan Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0605697 SPC/GB01/008 United Kingdom   Start Trial PRODUCT NAME: 1-(((3-(2-(DIMETHYLAMINO)ETHYL)INDOL-5-YL)METHYL)SULFONYL)PYRROLIDINE GENERIC NAME ALMOTRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY AS ALMOTRIPTAN D,L - HYDROGEN MALATE; REGISTERED: ES 62.877 19991223; UK PL 16973/0005 20001026
0719278 23/2003 Austria   Start Trial PRODUCT NAME: DUTASTERIDE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SOLVATES; NAT. REGISTRATION NO/DATE: 1-24844, 1-24845 20030217; FIRST REGISTRATION: SE 17871, 17872 20020719
0303507 64/1997 Austria   Start Trial PRODUCT NAME: ''NARATRIPTAN'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER SOLVATES EINSCHLIESSLICH DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: 1-22059 19970731; FIRST REGISTRATION: SE 13382 19970310
0933372 SPC/GB08/018 United Kingdom   Start Trial PRODUCT 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
0258618 SPC/GB01/042 United Kingdom   Start Trial PRODUCT NAME: ZOLEDRONIC ACID 2-(IMIDAZOL-1-YL)-1-HYDROXYETHANE-1,1-DIPHOSPHONIC ACID; REGISTERED: CH 55463 20001128; UK EU/1/01/176/001 20010320; UK EU/1/01/176/002 20010320; UK EU/1/01/176/003 20010320
1301519 300803 Netherlands   Start Trial PRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123
0434450 990028 Netherlands   Start Trial PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER, IN HET BIJZONDER ABACAVIR SULFAAT; REGISTRATION NO/DATE: EU/1/99/112/001-002 19990708
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Colorcon
Merck
Moodys
Medtronic

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