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Osmotica Company Profile

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

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.

Summary for Osmotica

International Patents:	29
US Patents:	3
Tradenames:	9
Ingredients:	9
NDAs:	10

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	METHYLPHENIDATE HYDROCHLORIDE	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205327-003	Jul 28, 2017	AB	RX	No	No
Osmotica Pharm Corp	KHEDEZLA	desvenlafaxine	TABLET, EXTENDED RELEASE;ORAL	204683-002	Jul 10, 2013	BC	RX	No	No
Osmotica	OMTRYG	omega-3-acid ethyl esters type a	CAPSULE;ORAL	204977-001	Apr 23, 2014		DISCN	Yes	No
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-002	May 20, 2008	AB	RX	Yes	No

Expired US Patents for Osmotica

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	022104-002	May 20, 2008	6,419,958
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-003	May 20, 2008	6,403,120
Osmotica Pharm	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-001	May 20, 2008	6,403,120

Non-Orange Book US Patents for Osmotica

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 Drugs

Country	Document Number	Estimated Expiration
China	1228020
Israel	128043
Brazil	9802144
Argentina	053986

Supplementary Protection Certificates for Osmotica 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