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Serving 500+ biopharmaceutical companies globally:

Medtronic
Moodys
Argus Health
Boehringer Ingelheim
Colorcon
Merck
Deloitte
US Army
Teva
Harvard Business School

Generated: July 23, 2017

DrugPatentWatch Database Preview

Ortho Mcneil Company Profile

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

ORTHO MCNEIL has thirty-eight approved drugs.

There are ten US patents protecting ORTHO MCNEIL drugs.

There are one hundred and fifty-eight patent family members on ORTHO MCNEIL drugs in thirty countries.

Summary for Applicant: Ortho Mcneil

Patents:10
Tradenames:42
Ingredients:22
NDAs:38
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ortho Mcneil Pharm
ORTHO-NOVUM 1/80 28
mestranol; norethindrone
TABLET;ORAL-28016715-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Ortho Mcneil Janssen
ORTHO-NOVUM 10/11-28
ethinyl estradiol; norethindrone
TABLET;ORAL-28018354-002Jan 11, 1982DISCNYesNo► Subscribe► Subscribe
Ortho Mcneil Pharm
TYLOX-325
acetaminophen; oxycodone hydrochloride
CAPSULE;ORAL088246-001Nov 8, 1984DISCNNoNo► Subscribe► Subscribe
Ortho Mcneil Pharm
THEOPHYL
theophylline
TABLET, CHEWABLE;ORAL086506-001Sep 12, 1985DISCNNoNo► Subscribe► Subscribe
Ortho Mcneil Pharm
TYLENOL W/ CODEINE NO. 3
acetaminophen; codeine phosphate
CAPSULE;ORAL087422-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
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Expired Patents for Ortho Mcneil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ortho Mcneil Janssen
VIADUR
leuprolide acetate
IMPLANT;IMPLANTATION021088-001Mar 3, 20005,985,305► Subscribe
Ortho Mcneil
HALDOL
haloperidol
TABLET;ORAL015921-005Approved Prior to Jan 1, 19823,438,991► Subscribe
Ortho Mcneil Pharm
FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ofloxacin
INJECTABLE;INJECTION020087-004Mar 31, 19924,382,892► Subscribe
Ortho Mcneil
HALDOL
haloperidol
TABLET;ORAL015921-006Feb 2, 19823,438,991► Subscribe
Ortho Mcneil Janssen
VIADUR
leuprolide acetate
IMPLANT;IMPLANTATION021088-001Mar 3, 20006,395,292► Subscribe
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Non-Orange Book Patents for Ortho Mcneil

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
8,298,562Sustained delivery of an active agent using an implantable system► Subscribe
8,535,701Sustained delivery of an active agent using an implantable system► Subscribe
6,261,584 Sustained delivery of an active agent using an implantable system► Subscribe
7,655,257Sustained delivery of an active agent using an implantable system► Subscribe
8,080,259Sustained delivery of an active agent using an implantable system► 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 Ortho Mcneil Drugs

Country Document Number Estimated Expiration
Austria537818► Subscribe
Germany69731013► Subscribe
Germany69715639► Subscribe
Poland328202► Subscribe
Taiwan584562► 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 Ortho Mcneil Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0021Belgium► SubscribePRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
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
C0040Belgium► SubscribePRODUCT NAME: ALATROFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/060/001 19980327; FIRST REGISTRATION: CH 54484 19980327
80016Netherlands► SubscribePRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606
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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 500+ biopharmaceutical companies globally:

Express Scripts
Moodys
Farmers Insurance
Queensland Health
Julphar
Medtronic
Daiichi Sankyo
McKesson
UBS
Fish and Richardson

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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