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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Julphar
Queensland Health
McKinsey
Accenture
Healthtrust
Harvard Business School
Baxter
Chinese Patent Office

Generated: October 21, 2018

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Egalet Company Profile

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

EGALET has three approved drugs.

There are nine US patents protecting EGALET drugs.

Summary for Egalet
US Patents:9
Tradenames:3
Ingredients:3
NDAs:3

Drugs and US Patents for Egalet

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Egalet ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-002 Jan 9, 2017 DISCN Yes No 9,549,899 ➤ Sign Up Y ➤ Sign Up
Egalet ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-001 Jan 9, 2017 DISCN Yes No 9,044,402 ➤ Sign Up Y ➤ Sign Up
Egalet Us Inc OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-002 Jun 17, 2011 RX No No 7,201,920 ➤ Sign Up Y ➤ Sign Up
Egalet ARYMO ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 208603-003 Jan 9, 2017 DISCN Yes No 9,044,402 ➤ Sign Up Y ➤ Sign Up
Egalet Us Inc OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-002 Jun 17, 2011 RX No No 7,981,439 ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for EGALET drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 15 mg, 30 mg and 60 mg ➤ Subscribe 2017-12-29
➤ Subscribe Nasal Spray 15.75 mg/spray ➤ Subscribe 2012-03-12

Supplementary Protection Certificates for Egalet Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
923 Luxembourg ➤ Sign Up PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
2015 00072 Denmark ➤ Sign Up PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
2015000111 Germany ➤ Sign Up PRODUCT 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
/2015 Austria ➤ Sign Up PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730
292 Luxembourg ➤ Sign Up PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Farmers Insurance
US Army
Moodys
Medtronic
Deloitte
Dow
Cipla

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