Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 20, 2019

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Osmotica Company Profile

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Summary for Osmotica
International Patents:11
US Patents:4
Tradenames:9
Ingredients:9
NDAs:9
Patent Litigation for Osmotica: See patent lawsuits for Osmotica

Drugs and US Patents for Osmotica

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 RX Yes No 10,213,393   Start Trial   Start Trial
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-001 Feb 16, 2018 RX Yes No 10,213,394   Start Trial   Start Trial
Osmotica METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 205327-002 Jul 28, 2017 AB RX No No   Start Trial   Start Trial
Osmotica METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 205327-005 Jul 28, 2017 RX No Yes   Start Trial   Start Trial
Osmotica OMTRYG omega-3-acid ethyl esters type a CAPSULE;ORAL 204977-001 Apr 23, 2014 DISCN Yes No   Start Trial   Start Trial
Osmotica HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205629-003 Jul 7, 2016 AB RX No No   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 Osmotica

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 RE39069   Start Trial
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-003 May 20, 2008 6,403,120   Start Trial
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-002 May 20, 2008 6,403,120   Start Trial
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-001 May 20, 2008 6,403,120   Start Trial
Osmotica Pharm VENLAFAXINE HYDROCHLORIDE venlafaxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 022104-004 May 20, 2008 6,403,120   Start Trial
Osmotica Pharm OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-001 Feb 16, 2018 RE39069   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for Osmotica Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0296560 SPC/GB97/023 United Kingdom   Start Trial PRODUCT NAME: DONEPEZIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE HYDROCHLORIDE; REGISTERED: UK PL 10555/0006 19970214; UK PL 10555/0007 19970214
0296560 2/1998 Austria   Start Trial PRODUCT NAME: DONEPEZIL UND SEINE PHARMAKOLOGISCH ANNEHMBAREN SALZE, INSBESONDERE DONEPEZIL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-22056, 1-22057 19970728; FIRST REGISTRATION: GB PL105550006, PL105550007 19970214
>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:

Dow
Moodys
AstraZeneca
McKesson
Johnson and Johnson
McKinsey

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