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Osmotica Pharm Company Profile

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What is the competitive landscape for OSMOTICA PHARM, and when can generic versions of OSMOTICA PHARM drugs launch?

OSMOTICA PHARM has seven approved drugs.

There are three US patents protecting OSMOTICA PHARM drugs.

Summary for Osmotica Pharm

US Patents:	3
Tradenames:	6
Ingredients:	6
NDAs:	7
Patent Litigation for Osmotica Pharm:	See patent lawsuits for Osmotica Pharm

Drugs and US Patents for Osmotica Pharm

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	8,252,331		Y
Osmotica Pharm Us	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	077127-002	Nov 21, 2005	AB2	RX	No	No
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-003	Feb 16, 2018		RX	Yes	Yes	8,574,626		Y
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-004	May 20, 2008	AB	RX	Yes	No
Osmotica Pharm Us	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	077127-001	Nov 21, 2005	AB2	RX	No	No

Expired US Patents for Osmotica Pharm

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
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-002	May 20, 2008	6,403,120
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-004	May 20, 2008	6,403,120
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-001	Feb 16, 2018	RE39069
Osmotica Pharm	OSMOLEX ER	amantadine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209410-002	Feb 16, 2018	RE39069

Non-Orange Book US Patents for Osmotica Pharm

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,004,582	Multi-layered osmotic device

International Patents for Osmotica Pharm Drugs

Country	Document Number	Estimated Expiration
European Patent Office	0914098
European Patent Office	1834638
Mexico	2007006472
Brazil	9802144
World Intellectual Property Organization (WIPO)	2006089494

Supplementary Protection Certificates for Osmotica Pharm Drugs

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

Similar Applicant Names

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

• Osmotica
• Osmotica Pharm
• Osmotica Pharm Corp
• Osmotica Pharm Us