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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Chinese Patent Office
Cantor Fitzgerald
Fish and Richardson
AstraZeneca
Harvard Business School
Accenture
Fuji
McKesson
Daiichi Sankyo

Generated: September 22, 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-one patent family members on MYLAN SPECIALITY LP drugs in forty countries.

Summary for Applicant: Mylan Speciality Lp

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
DEMADEX
torsemide
TABLET;ORAL020136-004Aug 23, 1993ABRXYesNo► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
SFROWASA
mesalamine
ENEMA;RECTAL019618-002Jun 20, 2008ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
Mylan Speciality Lp
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-003Nov 19, 1996RXYesYes► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
EPIPEN
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-001Dec 22, 1987BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
DEMADEX
torsemide
TABLET;ORAL020136-001Aug 23, 1993ABRXYesNo► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
COLYTE
polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous
FOR SOLUTION;ORAL018983-004Oct 26, 1984DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
EPIPEN
epinephrine
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS019430-001Dec 22, 1987BXRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Speciality Lp
ASTELIN
azelastine hydrochloride
SPRAY, METERED;NASAL020114-001Nov 1, 1996ABRXYesYes► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
CROMOLYN SODIUM
cromolyn sodium
SOLUTION;INHALATION074209-001Apr 26, 1994ANRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
OPTIVAR
azelastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021127-001May 22, 2000ATRXYesYes► 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
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-003Nov 19, 1996► Subscribe► Subscribe
Mylan Speciality Lp
FELBATOL
felbamate
SUSPENSION;ORAL020189-003Jul 29, 1993► Subscribe► Subscribe
Mylan Speciality Lp
FELBATOL
felbamate
TABLET;ORAL020189-001Jul 29, 1993► Subscribe► Subscribe
Mylan Speciality Lp
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-004Nov 19, 1996► Subscribe► Subscribe
Mylan Speciality Lp
DEMADEX
torsemide
TABLET;ORAL020136-004Aug 23, 1993► Subscribe► Subscribe
Mylan Speciality Lp
FELBATOL
felbamate
TABLET;ORAL020189-002Jul 29, 1993► Subscribe► Subscribe
Mylan Speciality Lp
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-003Nov 19, 1996► Subscribe► Subscribe
Mylan Speciality Lp
DEMADEX
torsemide
TABLET;ORAL020136-003Aug 23, 1993► Subscribe► Subscribe
Mylan Speciality Lp
DEMADEX
torsemide
TABLET;ORAL020136-001Aug 23, 1993► Subscribe► Subscribe
Mylan Speciality Lp
MUSE
alprostadil
SUPPOSITORY;URETHRAL020700-004Nov 19, 1996► 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
8,217,082Reduced irritant enema for the treatment of inflammatory bowel disease (IBD)► Subscribe
8,084,461Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease► Subscribe
7,335,379Transdermal pharmaceutical formulation for minimizing skin residues► Subscribe
8,937,057Combination of azelastine and mometasone for nasal administration► Subscribe
8,758,816Compositions comprising azelastine and methods of use thereof► Subscribe
8,318,709Combination of azelastine and mometasone for nasal administration► Subscribe
7,214,381Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels► Subscribe
8,933,060Combination of azelastine and ciclesonide for nasal administration► Subscribe
8,454,996Pharmaceutical composition for the treatment of acute disorders► Subscribe
8,980,309Transdermal testosterone formulation for minimizing skin residues► 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
Cyprus1114620► Subscribe
Israel216931► Subscribe
China1607940► Subscribe
New Zealand510284► Subscribe
European Patent Office1323431► Subscribe
MexicoPA04003928► Subscribe
Japan4806712► Subscribe
Canada2418135► Subscribe
Poland1807156► Subscribe
Germany60143360► 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
2009004Lithuania► SubscribePRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
C/GB04/032United Kingdom► SubscribePRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
C0005Belgium► SubscribePRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
00714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2009004,C0770388Lithuania► SubscribePRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
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
0136011/03Switzerland► SubscribePRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
0130025 00090Estonia► SubscribePRODUCT NAME: FLUTIKASOON; ASELASTIIN;REG NO/DATE: EE 808513 04.03.2013
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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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Citi
McKesson
Daiichi Sankyo
Healthtrust
Farmers Insurance
Boehringer Ingelheim
Johnson and Johnson
Covington
Cerilliant
AstraZeneca

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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