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Last Updated: March 28, 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 Pharms Inc NIZATIDINE nizatidine CAPSULE;ORAL 075806-001 Jul 5, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mylan Institutional CARBOPLATIN carboplatin INJECTABLE;INTRAVENOUS 077998-001 Apr 24, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp FELBATOL felbamate TABLET;ORAL 020189-002 Jul 29, 1993 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial
Mylan AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM amlodipine besylate; atorvastatin calcium TABLET;ORAL 200465-002 Nov 29, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Mylan FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075207-003 May 25, 2007 DISCN 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
>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 for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ 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

Supplementary Protection Certificates for Mylan Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2582683 2019008 Norway ⤷  Try a Trial PRODUCT NAME: ALLOPURINOL/LESINURAD ELLER ET FARMASOEYTISK AKSEPTERBART SALT ELLER SALTER DERAV; REG. NO/DATE: EU/1/18/1300/001-004 20180904
0915894 SPC/GB05/041 United Kingdom ⤷  Try a Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020.
0275821 01C0035 France ⤷  Try a Trial PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
1499331 SPC/GB13/034 United Kingdom ⤷  Try a Trial PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
2217577 LUC00103 Luxembourg ⤷  Try a Trial PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OU UN/DES SEL(S) PHARMACEUTIQUEMENT ACCEPTABLE(S) DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1300 20180827
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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