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Serving leading biopharmaceutical companies globally:

Dow
Accenture
Queensland Health
Federal Trade Commission
UBS
QuintilesIMS
Mallinckrodt
Fish and Richardson
Farmers Insurance
Citi

Generated: November 20, 2017

DrugPatentWatch Database Preview

Mylan Speciality Lp Company Profile

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What is the competitive landscape for MYLAN SPECIALITY LP, and when can generic versions of MYLAN SPECIALITY LP drugs launch?

MYLAN SPECIALITY LP has thirty-five approved drugs.

There are nineteen US patents protecting MYLAN SPECIALITY LP drugs.

There are two hundred and sixty-two patent family members on MYLAN SPECIALITY LP drugs in forty countries and forty-five supplementary protection certificates in fifteen countries.

Summary for Mylan Speciality Lp

International Patents:262
US Patents:19
Tradenames:37
Ingredients:27
NDAs:35
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
ASTELIN
azelastine hydrochloride
SPRAY, METERED;NASAL020114-001Nov 1, 1996ABRXYesYes► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
ROWASA
mesalamine
ENEMA;RECTAL019618-001Dec 24, 1987ABRXYesYes► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
CESAMET
nabilone
CAPSULE;ORAL018677-001Dec 26, 1985RXYesYes► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-002Nov 19, 1996RXYesYes► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
CORTIFOAM
hydrocortisone acetate
AEROSOL, METERED;RECTAL017351-001Feb 10, 1982RXYesYes► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
ELESTRIN
estradiol
GEL, METERED;TRANSDERMAL021813-001Dec 15, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
DEPEN
penicillamine
TABLET;ORAL019854-001Approved Prior to Jan 1, 1982RXYesYes► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
ASTEPRO
azelastine hydrochloride
SPRAY, METERED;NASAL022203-002Aug 31, 2009ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
EDLUAR
zolpidem tartrate
TABLET;SUBLINGUAL021997-001Mar 13, 2009ABRXYesNo► Subscribe► Subscribe ► Subscribe
Mylan Speciality Lp
LEVALBUTEROL HYDROCHLORIDE
levalbuterol hydrochloride
SOLUTION;INHALATION077800-003Mar 15, 2013ANRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Mylan Speciality Lp

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp
FELBATOL
felbamate
TABLET;ORAL020189-001Jul 29, 1993► Subscribe► Subscribe
Mylan Speciality Lp
DEMADEX
torsemide
TABLET;ORAL020136-004Aug 23, 1993► Subscribe► Subscribe
Mylan Speciality Lp
FELBATOL
felbamate
SUSPENSION;ORAL020189-003Jul 29, 1993► Subscribe► Subscribe
Mylan Speciality Lp
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-004Nov 19, 1996► Subscribe► Subscribe
Mylan Speciality Lp
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-003Nov 19, 1996► Subscribe► Subscribe
Mylan Speciality Lp
CESAMET
nabilone
CAPSULE;ORAL018677-001Dec 26, 1985► Subscribe► Subscribe
Mylan Speciality Lp
GASTROCROM
cromolyn sodium
CONCENTRATE;ORAL020479-001Feb 29, 1996► Subscribe► Subscribe
Mylan Speciality Lp
DEMADEX
torsemide
TABLET;ORAL020136-003Aug 23, 1993► Subscribe► Subscribe
Mylan Speciality Lp
AEROSPAN HFA
flunisolide
AEROSOL, METERED;INHALATION021247-001Jan 27, 2006► Subscribe► Subscribe
Mylan Speciality Lp
CESAMET
nabilone
CAPSULE;ORAL018677-001Dec 26, 1985► Subscribe► Subscribe
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Paragraph IV activity for MYLAN SPECIALITY LP drugs

Drugname Dosage Strength Tradename Submissiondate
azelastine hydrochloride and fluticasone propionate
Nasal Spray137 mcg/50 mcg per spray
DYMISTA
6/13/2014
azelastine hydrochloride
Nasal Spray205.5 mcg/spray
ASTEPRO
12/15/2011
zolpidem tartrate
Sublingual Tablets5 mg and 10 mg
EDLUAR
4/29/2010
epinephrine
Injection (Auto-injector)0.15 mg/0.3 mL and 0.3 mg/0.3 mL
EPIPEN
11/21/2008
epinephrine
Injection (Auto-injector)0.15 mg/0.3 mL and 0.3 mg/0.3 mL
EPIPEN JR.
11/21/2008
azelastine hydrochloride
Ophthalmic Solution0.05%
OPTIVAR
12/13/2006
azelastine hydrochloride
Nasal Spray0.125 mg base/spray
ASTELIN
11/14/2005
albuterol sulfate
Inhalation Solution0.021% and 0.042%
ACCUNEB
10/19/2005

Non-Orange Book 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
8,084,461Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease► Subscribe
8,304,405Combination of azelastine and ciclesonide for nasal administration► Subscribe
7,214,381Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► Subscribe
7,335,379Transdermal pharmaceutical formulation for minimizing skin residues► Subscribe
8,758,816Compositions comprising azelastine and methods of use thereof► Subscribe
8,318,709Combination of azelastine and mometasone for nasal administration► Subscribe
8,652,491Transdermal compositions for anticholinergic agents► Subscribe
7,404,965Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► Subscribe
8,980,290Transdermal compositions for anticholinergic agents► Subscribe
8,937,057Combination of azelastine and mometasone for nasal administration► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Mylan Speciality Lp Drugs

Country Document Number Estimated Expiration
Spain2545205► Subscribe
Israel203925► Subscribe
World Intellectual Property Organization (WIPO)2005039531► Subscribe
Poland1807156► Subscribe
South Korea20110113782► Subscribe
European Patent Office1323431► Subscribe
Canada2464660► Subscribe
Slovenia1519731► Subscribe
BrazilPI0414551► Subscribe
Estonia05023► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Mylan Speciality Lp Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
636Luxembourg► SubscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
C0004Belgium► SubscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
C/GB10/012United Kingdom► SubscribePRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
5 5006-2013Slovakia► SubscribePRODUCT NAME: AZELASTIN ALEBO JEHO FARMACEUTICKY PRIJATE LNE SOLI A FARMACEUTICKY PRIJATEL NY ESTER FLUTIKAZONU; REGISTRATION NO/DATE: 24/0055/13-S 20130215
C0003Belgium► SubscribePRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
C0005Belgium► SubscribePRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

US Army
Federal Trade Commission
Merck
McKesson
Chubb
Boehringer Ingelheim
Farmers Insurance
Cerilliant
Teva
Citi

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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