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Last Updated: March 31, 2020

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Mylan Company Profile


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Summary for Mylan
International Patents:747
US Patents:60
Tradenames:619
Ingredients:555
NDAs:941
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 DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 090062-002 Mar 17, 2009 AB RX No No   Start Trial   Start Trial
Mylan Labs Ltd ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; ethynodiol diacetate TABLET;ORAL-28 204704-001 Feb 9, 2016 AB RX No No   Start Trial   Start Trial
Mylan LORATADINE loratadine TABLET;ORAL 076154-001 Aug 20, 2003 OTC No No   Start Trial   Start Trial
Mylan Speciality Lp OPTIVAR azelastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 021127-001 May 22, 2000 DISCN Yes No   Start Trial   Start Trial
Mylan ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 202395-002 Oct 10, 2013 DISCN No No   Start Trial   Start Trial
Mylan Institutional PENTOSTATIN pentostatin INJECTABLE;INJECTION 203554-001 Sep 19, 2014 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 EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-001 Mar 13, 2009 8,512,747   Start Trial
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-004 Nov 19, 1996 5,242,391   Start Trial
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-002 Jul 12, 1996 5,866,591*PED   Start Trial
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-003 Nov 19, 1996 5,886,039   Start Trial
Mylan Institutional RIMSO-50 dimethyl sulfoxide SOLUTION;INTRAVESICAL 017788-001 Approved Prior to Jan 1, 1982 3,549,770   Start Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 7,097,827   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 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
➤ 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

Supplementary Protection Certificates for Mylan Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2137537 C300674 Netherlands   Start Trial PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
1586316 122011100019 Germany   Start Trial PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
1412357 PA2008013,C1412357 Lithuania   Start Trial PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1919458 C300649 Netherlands   Start Trial PRODUCT NAME: CYSTEAMINE; REGISTRATION NO/DATE: EU/1/13/861/001-002 20130906
2137537 2014C/039 Belgium   Start Trial PRODUCT NAME: DIMETHYL FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/13/837/001 20140203
1606261 PA2010010 Lithuania   Start Trial PRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Dow
Medtronic
McKesson
Johnson and Johnson
Moodys
Boehringer Ingelheim

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 verification 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.