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McKesson
Medtronic
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Express Scripts
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Last Updated: October 15, 2019

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Mylan Speciality Lp Company Profile

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Summary for Mylan Speciality Lp
International Patents:486
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 SOMA carisoprodol TABLET;ORAL 011792-001 Approved Prior to Jan 1, 1982 AA RX Yes No   See Pricing   See Pricing
Mylan Speciality Lp EPIPEN epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-001 Dec 22, 1987 AB RX Yes Yes 7,449,012   See Pricing Y   See Pricing
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-001 Oct 15, 2008 DISCN No No 8,071,073   See Pricing Y   See Pricing
Mylan Speciality Lp EPIFOAM hydrocortisone acetate; pramoxine hydrochloride AEROSOL, METERED;TOPICAL 086457-001 Approved Prior to Jan 1, 1982 BX RX No No   See Pricing   See Pricing
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 RX Yes Yes 7,442,388   See Pricing Y   See Pricing
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-002 Aug 31, 2009 AB RX Yes Yes 9,919,050   See Pricing Y   See Pricing
>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 RE30633   See Pricing
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-001 Nov 19, 1996 5,242,391   See Pricing
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-002 Aug 23, 1993 RE34672   See Pricing
Mylan Speciality Lp CESAMET nabilone CAPSULE;ORAL 018677-001 Dec 26, 1985 4,087,545   See Pricing
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009 6,761,910   See Pricing
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-001 Nov 19, 1996 5,886,039   See Pricing
>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 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
2236132 CA 2015 00004 Denmark   See Pricing 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
0136011 99C0003 Belgium   See Pricing PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
1519731 13C0067 France   See Pricing 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
1519731 1390033-7 Sweden   See Pricing PRODUCT NAME: AZELASTIN, ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV, OCH EN FARMACEUTISKT GODTAGBAR ESTER AV FLUTIKASON; NAT. REG. NO/DATE: MTNR 47084 20130221; FIRST REG.: SK 24/0055/13-S 20130215
0771217 07C0001 France   See Pricing PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1519731 175 5006-2013 Slovakia   See Pricing PRODUCT NAME: AZELASTIN ALEBO JEHO FARMACEUTICKY PRIJATE LNE SOLI A FARMACEUTICKY PRIJATEL NY ESTER FLUTIKAZONU; REGISTRATION NO/DATE: 24/0055/13-S 20130215
>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:

Boehringer Ingelheim
McKesson
Mallinckrodt
Johnson and Johnson
Baxter
McKinsey

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