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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Merck
Harvard Business School
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Medtronic
Boehringer Ingelheim
Colorcon
Daiichi Sankyo

Generated: October 22, 2018

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Mylan Speciality Lp Company Profile

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

MYLAN SPECIALITY LP has thirty-five approved drugs.

There are twenty-one US patents protecting MYLAN SPECIALITY LP drugs.

Summary for Mylan Speciality Lp
US Patents:21
Tradenames:37
Ingredients:27
NDAs:35

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 7,449,012 ➤ Try a Free Trial Y ➤ Try a Free Trial
Mylan Speciality Lp EPIPEN JR. epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-002 Dec 22, 1987 AB RX Yes Yes 9,586,010 ➤ Try a Free Trial Y ➤ Try a Free Trial
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009 AB RX Yes Yes 8,512,747 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Speciality Lp SFROWASA mesalamine ENEMA;RECTAL 019618-002 Jun 20, 2008 AB RX Yes No 7,645,801 ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-001 Oct 15, 2008 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Speciality Lp LUFYLLIN dyphylline TABLET;ORAL 084566-001 Approved Prior to Jan 1, 1982 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 MUSE alprostadil SUPPOSITORY;URETHRAL 020700-002 Nov 19, 1996 4,801,587 ➤ Try a Free Trial
Mylan Speciality Lp FELBATOL felbamate SUSPENSION;ORAL 020189-003 Jul 29, 1993 4,978,680 ➤ Try a Free Trial
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-004 Nov 19, 1996 4,801,587 ➤ Try a Free Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-004 Aug 23, 1993 4,018,929 ➤ Try a Free Trial
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-001 Nov 19, 1996 5,474,535 ➤ Try a Free Trial
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-003 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 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 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 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

Supplementary Protection Certificates for Mylan Speciality Lp Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0005 Belgium ➤ Try a Free Trial PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
2009 Austria ➤ Try a Free Trial PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
269 Luxembourg ➤ Try a Free Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
C0067 France ➤ Try a Free Trial PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
4 Finland ➤ Try a Free Trial
C0004 Belgium ➤ Try a Free Trial PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
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:

Healthtrust
Merck
Baxter
Farmers Insurance
US Army
Boehringer Ingelheim
AstraZeneca
Daiichi Sankyo
Johnson and Johnson

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