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Osmotica Company Profile

OSMOTICA has ten approved drugs.

There are three US patents protecting OSMOTICA drugs.

There are twenty-nine patent family members on OSMOTICA drugs in fourteen countries and two supplementary protection certificates in two countries.

International Patents:	29
US Patents:	3
Tradenames:	9
Ingredients:	9
NDAs:	10
Patent Litigation for Osmotica:	See patent lawsuits for Osmotica

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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	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205327-002	Jul 28, 2017	AB	RX	No	No		➤ Sign Up				➤ Sign Up
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018		RX	Yes	No	8,574,626	➤ Sign Up	Y			➤ Sign Up
Osmotica	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205327-004	Jul 28, 2017	AB	RX	No	No		➤ Sign Up				➤ Sign Up
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-001	May 20, 2008	AB	RX	Yes	No		➤ Sign Up				➤ Sign Up
Osmotica	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205629-002	Jul 7, 2016	AB	RX	No	No		➤ Sign Up				➤ Sign Up
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018		RX	Yes	No	8,252,331	➤ Sign Up	Y			➤ Sign Up
Osmotica	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205629-004	Jul 7, 2016	AB	RX	No	No		➤ Sign Up				➤ 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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-001	May 20, 2008	6,419,958	➤ Sign Up
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018	RE39069	➤ Sign Up
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-003	May 20, 2008	6,419,958	➤ Sign Up
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-003	May 20, 2008	6,403,120	➤ Sign Up
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-002	May 20, 2008	6,403,120	➤ Sign Up
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-002	May 20, 2008	6,419,958	➤ Sign Up
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-004	May 20, 2008	6,403,120	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1998	Austria	➤ Sign Up	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
C/GB97/023	United Kingdom	➤ Sign Up	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
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

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