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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Citi
Baxter
Deloitte
QuintilesIMS
Johnson and Johnson

Generated: April 21, 2019

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Mylan Speciality Lp Company Profile

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Summary for Mylan Speciality Lp
International Patents:446
US Patents:28
Tradenames:39
Ingredients:28
NDAs:37

Drugs and US Patents for Mylan Speciality Lp

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality Lp EPIPEN JR. epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-002 Dec 22, 1987 AB RX Yes Yes 8,048,035 ➤ Try a Free Trial Y ➤ Try a Free Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-001 Aug 23, 1993 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Speciality Lp IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 075553-001 Mar 31, 2003 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Speciality Lp EPIPEN epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-001 Dec 22, 1987 AB RX Yes Yes 9,586,010 ➤ Try a Free Trial Y ➤ Try a Free Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes 8,069,851 ➤ Try a Free Trial Y ➤ Try a Free Trial
Mylan Speciality Lp COLYTE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SOLUTION;ORAL 018983-007 Jun 12, 1987 DISCN 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 Speciality Lp

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-003 Aug 23, 1993 4,018,929 ➤ Try a Free Trial
Mylan Speciality Lp CESAMET nabilone CAPSULE;ORAL 018677-001 Dec 26, 1985 3,920,809 ➤ Try a Free Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-002 Aug 23, 1993 4,018,929 ➤ Try a Free Trial
Mylan Speciality Lp CESAMET nabilone CAPSULE;ORAL 018677-001 Dec 26, 1985 3,928,598 ➤ Try a Free Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-004 Aug 23, 1993 RE34672 ➤ Try a Free Trial
Mylan Speciality Lp CESAMET nabilone CAPSULE;ORAL 018677-001 Dec 26, 1985 4,087,545 ➤ 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 SPECIALITY LP drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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 205.5 mcg/spray ➤ Subscribe 2011-12-15
➤ Subscribe Sublingual Tablets 5 mg and 10 mg ➤ Subscribe 2010-04-29
➤ 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 0.125 mg base/spray ➤ Subscribe 2005-11-14
➤ Subscribe Nasal Spray 137 mcg/50 mcg per spray ➤ Subscribe 2014-06-13

Supplementary Protection Certificates for Mylan Speciality Lp Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 2009/012 Ireland ➤ Try a Free Trial PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
0809498 SPC/GB10/012 United Kingdom ➤ Try a Free Trial PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0398460 12/2004 Austria ➤ Try a Free Trial PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
1519731 C20130025 00090 Estonia ➤ Try a Free Trial PRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013
1380301 2009C/007 Belgium ➤ Try a Free Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1280520 14/2015 Austria ➤ Try a Free Trial PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
Patent Number 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.

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
McKesson
UBS
Covington
McKinsey
AstraZeneca

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