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Last Updated: February 17, 2020

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Mylan Speciality Lp Company Profile


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Summary for Mylan Speciality Lp
International Patents:492
US Patents:32
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 DEMADEX torsemide TABLET;ORAL 020136-003 Aug 23, 1993 AB RX Yes Yes   Start Trial   Start Trial
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes 8,715,623   Start Trial Y   Start Trial
Mylan Speciality Lp EPIPEN JR. epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-002 Dec 22, 1987 AB RX Yes Yes 9,586,010   Start Trial Y   Start Trial
Mylan Speciality Lp LEVALBUTEROL HYDROCHLORIDE levalbuterol hydrochloride SOLUTION;INHALATION 078309-001 Mar 20, 2009 AN RX 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 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 RE34672   Start Trial
Mylan Speciality Lp ASTELIN azelastine hydrochloride SPRAY, METERED;NASAL 020114-001 Nov 1, 1996 5,164,194*PED   Start Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-002 Aug 23, 1993 4,822,807   Start Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-004 Aug 23, 1993 4,822,807   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for MYLAN SPECIALITY LP drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ 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

Supplementary Protection Certificates for Mylan Speciality Lp Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 09C0018 France   Start Trial PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0770388 PA2009004 Lithuania   Start Trial PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
1453521 15C0050 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
0398460 SPC/GB04/032 United Kingdom   Start Trial PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Serving leading biopharmaceutical companies globally:

Harvard Business School
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Dow
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