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Last Updated: December 23, 2024

MYLAN SPECIALITY LP Company Profile


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Summary for MYLAN SPECIALITY LP
International Patents:181
US Patents:20
Tradenames:22
Ingredients:16
NDAs:19

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 ROWASA mesalamine ENEMA;RECTAL 019618-001 Dec 24, 1987 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe
Mylan Speciality Lp EPIPEN epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-001 Dec 22, 1987 AB RX Yes Yes 9,586,010 ⤷  Subscribe Y ⤷  Subscribe
Mylan Speciality Lp EPIPEN JR. epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-002 Dec 22, 1987 AB RX Yes Yes 8,048,035 ⤷  Subscribe Y ⤷  Subscribe
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-001 Oct 15, 2008 DISCN Yes No 8,071,073 ⤷  Subscribe Y ⤷  Subscribe
Mylan Speciality Lp EPIPEN epinephrine INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS 019430-001 Dec 22, 1987 AB RX Yes Yes 8,870,827 ⤷  Subscribe Y ⤷  Subscribe
Mylan Speciality Lp ASTEPRO azelastine hydrochloride SPRAY, METERED;NASAL 022203-001 Oct 15, 2008 DISCN Yes No 8,518,919 ⤷  Subscribe ⤷  Subscribe
>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 020700-003 Nov 19, 1996 5,242,391 ⤷  Subscribe
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-004 Nov 19, 1996 5,773,020 ⤷  Subscribe
Mylan Speciality Lp TOBI PODHALER tobramycin POWDER;INHALATION 201688-001 Mar 22, 2013 11,484,671 ⤷  Subscribe
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-004 Nov 19, 1996 5,474,535 ⤷  Subscribe
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-003 Nov 19, 1996 5,773,020 ⤷  Subscribe
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-003 Nov 19, 1996 4,801,587 ⤷  Subscribe
>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
0584952 99C0004 Belgium ⤷  Subscribe PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
1519731 PA2013023 Lithuania ⤷  Subscribe PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004
1280520 C300722 Netherlands ⤷  Subscribe PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
0770388 2009/012 Ireland ⤷  Subscribe PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
1519731 1390033-7 Sweden ⤷  Subscribe 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
0770388 9/2009 Austria ⤷  Subscribe PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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