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Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
US Army
McKinsey
Healthtrust
Fuji
McKesson
AstraZeneca
Deloitte
Accenture

Generated: December 17, 2017

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Luitpold Company Profile

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What is the competitive landscape for LUITPOLD, and what generic alternatives to LUITPOLD drugs are available?

LUITPOLD has ninety-five approved drugs.

There are four US patents protecting LUITPOLD drugs.

There are fifty-six patent family members on LUITPOLD drugs in thirty countries and ninety-three supplementary protection certificates in eleven countries.

Summary for Luitpold

International Patents:56
US Patents:4
Tradenames:76
Ingredients:73
NDAs:95
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Luitpold Pharms IncINJECTAFERferric carboxymaltoseINJECTABLE;INTRAVENOUS203565-001Jul 25, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
LuitpoldMETHYLERGONOVINE MALEATEmethylergonovine maleateINJECTABLE;INJECTION090193-001Nov 24, 2008APRXNoNo► Subscribe► Subscribe► Subscribe
LuitpoldNITROGLYCERINnitroglycerinINJECTABLE;INJECTION072034-001May 24, 1988RXNoYes► Subscribe► Subscribe► Subscribe
LuitpoldACETYLCYSTEINEacetylcysteineSOLUTION;INHALATION, ORAL072547-001Jul 28, 1995ANRXNoYes► Subscribe► Subscribe► Subscribe
Luitpold Pharms IncGEMCITABINE HYDROCHLORIDEgemcitabine hydrochlorideINJECTABLE;INJECTION202031-002May 7, 2013APRXNoNo► Subscribe► Subscribe► Subscribe
LuitpoldLIDOCAINE HYDROCHLORIDElidocaine hydrochlorideINJECTABLE;INJECTION083198-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
LuitpoldCAFFEINE CITRATEcaffeine citrateSOLUTION;ORAL090064-001Nov 20, 2009AARXNoNo► Subscribe► Subscribe► Subscribe
LuitpoldVENOFERiron sucroseINJECTABLE;INTRAVENOUS021135-001Nov 6, 2000RXYesYes► Subscribe► Subscribe► Subscribe
LuitpoldDORZOLAMIDE HYDROCHLORIDEdorzolamide hydrochlorideSOLUTION/DROPS;OPHTHALMIC079186-001Nov 18, 2009ATRXNoNo► Subscribe► Subscribe► Subscribe
LuitpoldHYDRALAZINE HYDROCHLORIDEhydralazine hydrochlorideINJECTABLE;INJECTION040136-001Jun 30, 1997APRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Luitpold

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
LuitpoldDEXFERRUMiron dextranINJECTABLE;INJECTION040024-001Feb 23, 1996► Subscribe► Subscribe
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Non-Orange Book Patents for Luitpold

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
8,431,549Methods and compositions for administration of iron► 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 Luitpold Drugs

Country Document Number Estimated Expiration
Taiwan200420289► Subscribe
South Africa200504174► Subscribe
Saudi Arabia2095► Subscribe
Norway20110654► Subscribe
South Korea100992178► Subscribe
Slovenia2287204► Subscribe
South Korea20140117678► Subscribe
Japan4777653► Subscribe
European Patent Office1973549► Subscribe
Denmark1973549► 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 Luitpold Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009Austria► SubscribePRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
2008006,C0933372Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
/2015Austria► SubscribePRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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
2015000111Germany► SubscribePRODUCT NAME: OKULARE IRRIGATIONSLOESUNG, WELCHE PHENYLEPHRIN ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UND KETOROLAC ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UMFASST; REGISTRATION NO/DATE: EU/1/15/1018 20150728
/2008Austria► SubscribePRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
C/GB09/024United Kingdom► SubscribePRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4
C/GB98/019United Kingdom► SubscribePRODUCT NAME: A COMBINATION COMPRISING LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND ZIDOVUDINE; REGISTERED: UK EU/1/98/058/001 19980318; UK EU/1/98/058/002 19980318
C/GB09/026United Kingdom► SubscribePRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
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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 plans and pricing

Serving leading biopharmaceutical companies globally:

Covington
UBS
Queensland Health
Julphar
Teva
Baxter
Cipla
Chubb
US Army
Cantor Fitzgerald

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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