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Last Updated: June 14, 2021

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MYLAN SPECIALITY LP Company Profile


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Summary for MYLAN SPECIALITY LP
International Patents:274
US Patents:29
Tradenames:38
Ingredients:27
NDAs:36

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 DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 AB RX Yes Yes 8,168,620*PED   Get Started Free Y   Get Started Free
Mylan Speciality Lp METAPROTERENOL SULFATE metaproterenol sulfate SOLUTION;INHALATION 071786-001 Aug 5, 1988 DISCN No No   Get Started Free   Get Started Free
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes 7,368,102   Get Started Free Y   Get Started Free
Mylan Speciality Lp BUTISOL SODIUM butabarbital sodium TABLET;ORAL 000793-002 Approved Prior to Jan 1, 1982 DISCN No No   Get Started Free   Get Started Free
Mylan Speciality Lp EPIPEN JR. epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-002 Dec 22, 1987 AB RX Yes Yes 9,586,010   Get Started Free Y   Get Started Free
>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 FELBATOL felbamate TABLET;ORAL 020189-001 Jul 29, 1993 4,978,680   Get Started Free
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-002 Aug 23, 1993 RE34672   Get Started Free
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-004 Nov 19, 1996 5,242,391   Get Started Free
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-004 Nov 19, 1996 4,801,587   Get Started Free
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-004 Nov 19, 1996 5,474,535   Get Started Free
>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 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
➤ 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

Supplementary Protection Certificates for MYLAN SPECIALITY LP Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1380301 2009C/007 Belgium   Get Started Free PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0402407 97C0005 Belgium   Get Started Free PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
2236132 92636 Luxembourg   Get Started Free PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132 CA 2015 00004 Denmark   Get Started Free PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
2236132 C300714 Netherlands   Get Started Free PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
>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:

Express Scripts
McKesson
Dow
Merck
Harvard Business School
Baxter

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