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Last Updated: November 21, 2024

Mylan Speciality Lp Company Profile


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Summary for Mylan Speciality Lp
International Patents:181
US Patents:20
Tradenames:23
Ingredients:17
NDAs:20

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 EPI E Z PEN JR epinephrine INJECTABLE;INTRAMUSCULAR 019430-004 Aug 3, 1995 DISCN No No ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-004 Nov 19, 1996 DISCN Yes No ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-003 Nov 19, 1996 DISCN Yes No ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp ELESTRIN estradiol GEL, METERED;TRANSDERMAL 021813-001 Dec 15, 2006 RX Yes Yes ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp SOMA carisoprodol TABLET;ORAL 011792-004 Sep 13, 2007 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp FELBATOL felbamate SUSPENSION;ORAL 020189-003 Jul 29, 1993 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up
>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 MUSE alprostadil SUPPOSITORY;URETHRAL 020700-001 Nov 19, 1996 5,773,020 ⤷  Sign Up
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-001 Nov 19, 1996 5,474,535 ⤷  Sign Up
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 8,715,623 ⤷  Sign Up
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 7,516,741 ⤷  Sign Up
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-001 Mar 13, 2009 6,761,910 ⤷  Sign Up
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-002 Nov 19, 1996 5,242,391 ⤷  Sign Up
>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 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 300 mg/5 mL ➤ Subscribe 2009-06-29
➤ 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
0334429 97C0002 Belgium ⤷  Sign Up PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1280520 300722 Netherlands ⤷  Sign Up PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1453521 CA 2016 00016 Denmark ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1453521 15C0050 France ⤷  Sign Up 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 C300221 Netherlands ⤷  Sign Up PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1280520 122015000021 Germany ⤷  Sign Up 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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