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Osmotica Pharm Company Profile

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OSMOTICA PHARM has six approved drugs.

There are eight US patents protecting OSMOTICA PHARM drugs.

There are eleven patent family members on OSMOTICA PHARM drugs in nine countries and two supplementary protection certificates in two countries.

International Patents:	11
US Patents:	8
Tradenames:	6
Ingredients:	6
NDAs:	6
Patent Litigation for Osmotica Pharm:	See patent lawsuits for Osmotica Pharm

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Osmotica Pharm Corp	KHEDEZLA	desvenlafaxine	TABLET, EXTENDED RELEASE;ORAL	204683-001	Jul 10, 2013		DISCN	No	No		Start Trial				Start Trial
Osmotica Pharm Us	OXYBUTYNIN CHLORIDE	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	078503-001	Feb 4, 2009	AB	RX	No	No		Start Trial				Start Trial
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		RX	Yes	No	8,574,626	Start Trial	Y			Start Trial
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		RX	Yes	No	10,500,172	Start Trial				Start Trial
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		RX	Yes	Yes	8,574,626	Start Trial	Y			Start Trial
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		RX	Yes	No	8,252,331	Start Trial	Y			Start Trial
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		RX	Yes	No	10,500,172	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018	RE39069	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	022104-004	May 20, 2008	6,419,958	Start Trial
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-004	May 20, 2008	6,403,120	Start Trial
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-001	May 20, 2008	6,419,958	Start Trial
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-003	May 20, 2008	6,419,958	Start Trial
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-001	May 20, 2008	6,403,120	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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

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