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Last Updated: February 29, 2020

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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 seventeen approved drugs.

There are nine US patents protecting SEBELA IRELAND LTD drugs.

There are eighty-three patent family members on SEBELA IRELAND LTD drugs in thirty-six countries and two supplementary protection certificates in two countries.

Summary for Sebela Ireland Ltd
International Patents:83
US Patents:9
Tradenames:12
Ingredients:10
NDAs:17

Drugs and US Patents for Sebela Ireland Ltd

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 PRAMOSONE hydrocortisone acetate; pramoxine hydrochloride LOTION;TOPICAL 085980-001 Approved Prior to Jan 1, 1982 RX No No   Start Trial   Start Trial
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-002 Jul 3, 2003 RX Yes No 7,598,271   Start Trial Y   Start Trial
Sebela Ireland Ltd TRANDATE labetalol hydrochloride INJECTABLE;INJECTION 019425-001 Dec 31, 1985 DISCN Yes No   Start Trial   Start Trial
Sebela Ireland Ltd NAFTIN naftifine hydrochloride GEL;TOPICAL 204286-001 Jun 27, 2013 AB RX Yes Yes 8,778,365   Start Trial Y   Start Trial
Sebela Ireland Ltd NAFTIN naftifine hydrochloride GEL;TOPICAL 204286-001 Jun 27, 2013 AB RX Yes Yes 10,166,205   Start Trial Y   Start Trial
Sebela Ireland Ltd NAFTIN naftifine hydrochloride CREAM;TOPICAL 019599-002 Jan 13, 2012 AB RX Yes Yes   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Sebela Ireland Ltd

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 8,591,948   Start Trial
Sebela Ireland Ltd LOTRONEX alosetron hydrochloride TABLET;ORAL 021107-001 Feb 9, 2000 6,284,770   Start Trial
Sebela Ireland Ltd LOTRONEX alosetron hydrochloride TABLET;ORAL 021107-002 Dec 23, 2003 5,360,800   Start Trial
Sebela Ireland Ltd RIDAURA auranofin CAPSULE;ORAL 018689-001 May 24, 1985 4,364,923   Start Trial
Sebela Ireland Ltd BRISDELLE paroxetine mesylate CAPSULE;ORAL 204516-001 Jun 28, 2013 5,874,447   Start Trial
Sebela Ireland Ltd PEXEVA paroxetine mesylate TABLET;ORAL 021299-002 Jul 3, 2003 5,874,447   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for SEBELA IRELAND LTD drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 0.5 mg and 1 mg ➤ Subscribe 2010-12-02
➤ Subscribe Capsules 7.5 mg ➤ Subscribe 2014-04-07

Supplementary Protection Certificates for Sebela Ireland Ltd Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0809498 SPC/GB10/012 United Kingdom   Start Trial PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0809498 10C0038 France   Start Trial PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Boehringer Ingelheim
Dow
Medtronic
Baxter

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