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Serving 500+ biopharmaceutical companies globally:

McKinsey
Covington
Mallinckrodt
Cipla
US Department of Justice
Chubb
Healthtrust
Express Scripts
Baxter
Queensland Health

Generated: August 19, 2017

DrugPatentWatch Database Preview

Sebela Ireland Ltd Company Profile

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

SEBELA IRELAND LTD has twenty approved drugs.

There are eleven US patents protecting SEBELA IRELAND LTD drugs.

There are one hundred and thirteen patent family members on SEBELA IRELAND LTD drugs in thirty-nine countries.

Summary for Applicant: Sebela Ireland Ltd

Patents:11
Tradenames:14
Ingredients:13
NDAs:20
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sebela Ireland Ltd
IMURAN
azathioprine sodium
INJECTABLE;INJECTION017391-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Sebela Ireland Ltd
ONMEL
itraconazole
TABLET;ORAL022484-001Apr 29, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Sebela Ireland Ltd
TRANDATE
labetalol hydrochloride
INJECTABLE;INJECTION019425-001Dec 31, 1985DISCNYesNo► Subscribe► Subscribe► Subscribe
Sebela Ireland Ltd
MOTOFEN HALF-STRENGTH
atropine sulfate; difenoxin hydrochloride
TABLET;ORAL017744-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Sebela Ireland Ltd
NAFTIN
naftifine hydrochloride
CREAM;TOPICAL019599-002Jan 13, 2012ABRXYesYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Sebela Ireland Ltd

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd
RIDAURA
auranofin
CAPSULE;ORAL018689-001May 24, 1985► Subscribe► Subscribe
Sebela Ireland Ltd
RIDAURA
auranofin
CAPSULE;ORAL018689-001May 24, 1985► Subscribe► Subscribe
Sebela Ireland Ltd
NAFTIN
naftifine hydrochloride
GEL;TOPICAL019356-001Jun 18, 1990► Subscribe► Subscribe
Sebela Ireland Ltd
LOTRONEX
alosetron hydrochloride
TABLET;ORAL021107-002Dec 23, 2003► Subscribe► Subscribe
Sebela Ireland Ltd
NAFTIN
naftifine hydrochloride
GEL;TOPICAL019356-001Jun 18, 1990► Subscribe► Subscribe
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Paragraph IV activity for SEBELA IRELAND LTD drugs

Drugname Dosage Strength Tradename Submissiondate
paroxetine
Capsules7.5 mg
BRISDELLE
4/7/2014
alosetron hydrochloride
Tablets0.5 mg and 1 mg
LOTRONEX
12/2/2010

Non-Orange Book Patents for Sebela Ireland Ltd

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
9,446,131Topical compositions and methods for making and using same► Subscribe
6,900,327 4-phenylpiperidine compounds► Subscribe
9,452,173Topical compositions and methods for making and using same► Subscribe
9,149,431Itraconazole compositions with improved bioavailability► Subscribe
8,859,576Method of treating thermoregulatory dysfunction with paroxetine► 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 Sebela Ireland Ltd Drugs

Country Document Number Estimated Expiration
Australia2007282065► Subscribe
European Patent Office2068881► Subscribe
Australia2956297► Subscribe
Estonia9800304► Subscribe
CroatiaP970270► 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 Sebela Ireland Ltd Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB10/012United Kingdom► SubscribePRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
C0038France► SubscribePRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
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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:

Queensland Health
Medtronic
Fish and Richardson
Deloitte
Farmers Insurance
Cantor Fitzgerald
McKesson
Chubb
US Army
Covington

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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