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Serving leading biopharmaceutical companies globally:

Accenture
Express Scripts
QuintilesIMS
Medtronic
Daiichi Sankyo
Federal Trade Commission
Cerilliant
Fuji
Citi
US Department of Justice

Generated: January 16, 2018

DrugPatentWatch Database Preview

Mylan Speciality Lp Company Profile

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Summary for Mylan Speciality Lp
International Patents:258
US Patents:19
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 EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-001 Mar 13, 2009 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 075552-001 Mar 31, 2003 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-004 Nov 19, 1996 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp SOMA carisoprodol CAPSULE;ORAL 011792-003 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp COLYTE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SOLUTION;ORAL 018983-006 Oct 26, 1984 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp BUTISOL SODIUM butabarbital sodium TABLET;ORAL 000793-005 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-002 Aug 23, 1993 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp FELBATOL felbamate TABLET;ORAL 020189-001 Jul 29, 1993 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp AVC sulfanilamide CREAM;VAGINAL 006530-003 Jan 27, 1987 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-002 Mar 13, 2009 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 FELBATOL felbamate SUSPENSION;ORAL 020189-003 Jul 29, 1993 ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp CESAMET nabilone CAPSULE;ORAL 018677-001 Dec 26, 1985 ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp ROWASA mesalamine ENEMA;RECTAL 019618-001 Dec 24, 1987 ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-001 Nov 19, 1996 ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp AEROSPAN HFA flunisolide AEROSOL, METERED;INHALATION 021247-001 Jan 27, 2006 ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-002 Nov 19, 1996 ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp MUSE alprostadil SUPPOSITORY;URETHRAL 020700-002 Nov 19, 1996 ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-004 Aug 23, 1993 ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp GASTROCROM cromolyn sodium CONCENTRATE;ORAL 020479-001 Feb 29, 1996 ➤ Subscribe ➤ Subscribe
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-003 Aug 23, 1993 ➤ Subscribe ➤ Subscribe
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 Nasal Spray 137 mcg/50 mcg per spray ➤ Subscribe 6/13/2014
➤ Subscribe Nasal Spray 205.5 mcg/spray ➤ Subscribe 12/15/2011
➤ Subscribe Sublingual Tablets 5 mg and 10 mg ➤ Subscribe 4/29/2010
➤ Subscribe Injection (Auto-injector) 0.15 mg/0.3 mL and 0.3 mg/0.3 mL ➤ Subscribe 11/21/2008
➤ Subscribe Injection (Auto-injector) 0.15 mg/0.3 mL and 0.3 mg/0.3 mL ➤ Subscribe 11/21/2008
➤ Subscribe Ophthalmic Solution 0.05% ➤ Subscribe 12/13/2006
➤ Subscribe Nasal Spray 0.125 mg base/spray ➤ Subscribe 11/14/2005
➤ Subscribe Inhalation Solution 0.021% and 0.042% ➤ Subscribe 10/19/2005

Non-Orange Book US Patents for Mylan Speciality Lp

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,335,379 Transdermal pharmaceutical formulation for minimizing skin residues ➤ Subscribe
8,758,816 Compositions comprising azelastine and methods of use thereof ➤ Subscribe
8,084,461 Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease ➤ Subscribe
8,933,060 Combination of azelastine and ciclesonide for nasal administration ➤ Subscribe
8,304,405 Combination of azelastine and ciclesonide for nasal administration ➤ Subscribe
8,652,491 Transdermal compositions for anticholinergic agents ➤ Subscribe
8,937,057 Combination of azelastine and mometasone for nasal administration ➤ Subscribe
7,910,132 Pharmaceutical composition for the treatment of acute disorders ➤ Subscribe
7,387,788 Pharmaceutical compositions of nicotine and methods of use thereof ➤ Subscribe
7,214,381 Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for Mylan Speciality Lp Drugs

Supplementary Protection Certificates for Mylan Speciality Lp Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022 France ➤ Subscribe PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
00740 Netherlands ➤ Subscribe PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
C0002 Belgium ➤ Subscribe PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
2016 00016 Denmark ➤ Subscribe PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
2006 00038 Denmark ➤ Subscribe PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
2015000093 Germany ➤ Subscribe PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
C0003 Belgium ➤ Subscribe PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
156 Luxembourg ➤ Subscribe PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
C0001 France ➤ Subscribe PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
269 Luxembourg ➤ Subscribe PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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 leading biopharmaceutical companies globally:

Chinese Patent Office
Moodys
Express Scripts
Citi
Cantor Fitzgerald
Harvard Business School
Boehringer Ingelheim
Daiichi Sankyo
UBS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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