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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Fuji
Federal Trade Commission
Colorcon
Farmers Insurance
McKinsey
Cantor Fitzgerald
US Army
Johnson and Johnson

Generated: September 22, 2018

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Mylan Company Profile

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What is the competitive landscape for MYLAN, and when can generic versions of MYLAN drugs launch?

MYLAN has eight hundred and ninety-five approved drugs.

There are thirty-nine US patents protecting MYLAN drugs. There are fifty-three tentative approvals on MYLAN drugs.

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 Asi ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 090318-003 Sep 23, 2014 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Labs Ltd MITOMYCIN mitomycin INJECTABLE;INJECTION 202670-001 Oct 13, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Labs Ltd CYANOCOBALAMIN cyanocobalamin INJECTABLE;INJECTION 204829-001 Jun 5, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Ireland Ltd PIROXICAM piroxicam CAPSULE;ORAL 074116-001 Jun 15, 1993 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc RIZATRIPTAN BENZOATE rizatriptan benzoate TABLET, ORALLY DISINTEGRATING;ORAL 078173-002 Dec 31, 2012 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc SUMATRIPTAN AND NAPROXEN SODIUM naproxen sodium; sumatriptan succinate TABLET;ORAL 090872-001 Sep 4, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Mylan CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride CAPSULE;ORAL 074947-001 Apr 30, 1998 AB 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 Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-002 Jul 12, 1996 5,866,591*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 Speciality Lp ROWASA mesalamine ENEMA;RECTAL 019618-001 Dec 24, 1987 4,657,900 ➤ Try a Free Trial
Mylan Ireland Ltd MIACALCIN calcitonin salmon SPRAY, METERED;NASAL 020313-002 Aug 17, 1995 5,759,565 ➤ Try a Free Trial
Mylan Pharms Inc ZOVIRAX acyclovir TABLET;ORAL 020089-001 Apr 30, 1991 4,199,574 ➤ Try a Free Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-002 Aug 23, 1993 4,822,807 ➤ Try a Free Trial
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-004 Nov 19, 1996 5,242,391 ➤ 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 1 mg/vial, 2 mg/vial and 5 mg/vial ➤ Subscribe 2013-12-27
➤ 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 Ophthalmic Solution 0.05% ➤ Subscribe 2006-12-13
➤ Subscribe Nasal Spray 0.125 mg base/spray ➤ Subscribe 2005-11-14
➤ Subscribe Nasal Spray 137 mcg/50 mcg per spray ➤ Subscribe 2014-06-13
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
➤ Subscribe CapsulesInhalation Solution 0.02 mg/2 mL ➤ Subscribe 2009-01-21
➤ Subscribe for Injection 200 mcg/vial ➤ Subscribe 2015-05-01
➤ Subscribe Injection 1 mg/mL, 50 mL vials ➤ Subscribe 2011-12-16
➤ Subscribe Foam 2% ➤ Subscribe 2009-07-30
➤ 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 Inhalation Solution 0.021% and 0.042% ➤ Subscribe 2005-10-19
➤ Subscribe Nasal Spray 205.5 mcg/spray ➤ Subscribe 2011-12-15
➤ Subscribe Sublingual Tablets 5 mg and 10 mg ➤ Subscribe 2010-04-29
➤ 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

International Patents for Mylan Drugs

Supplementary Protection Certificates for Mylan Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0118 France ➤ Try a Free Trial PRODUCT NAME: ATORVASTATINE CALCIQUE TRIHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 21960 DU 19970321; REGISTRATION NO/DATE AT EEC: PL 00018/0240 DU 19961107
00125 Netherlands ➤ Try a Free Trial PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
C/GB12/038 United Kingdom ➤ Try a Free Trial PRODUCT NAME: TRAVOPROST; REGISTERED: UK EU/1/01/199/001-002 20011129
0781 Netherlands ➤ Try a Free Trial PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE, EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
0817637/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
C0003 Belgium ➤ Try a Free Trial PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
90038-5 Sweden ➤ Try a Free Trial PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140203
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:

QuintilesIMS
Moodys
Express Scripts
Argus Health
Federal Trade Commission
Healthtrust
Farmers Insurance
UBS
Cipla

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.