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Serving 500+ biopharmaceutical companies globally:

Chubb
Cipla
Dow
Covington
Mallinckrodt
Queensland Health
Harvard Business School
Teva
Chinese Patent Office
US Army

Generated: August 19, 2017

DrugPatentWatch Database Preview

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 seven approved drugs.

There are two US patents protecting OSMOTICA drugs.

There are eighty-seven patent family members on OSMOTICA drugs in forty-four countries.

Summary for Applicant: Osmotica

Patents:2
Tradenames:6
Ingredients:6
NDAs:7
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Osmotica Pharm Us
NIFEDIPINE
nifedipine
TABLET, EXTENDED RELEASE;ORAL077127-001Nov 21, 2005AB2RXNoNo► Subscribe► Subscribe► Subscribe
Osmotica Pharm Corp
KHEDEZLA
desvenlafaxine
TABLET, EXTENDED RELEASE;ORAL204683-002Jul 10, 2013BCRXNoNo► Subscribe► Subscribe► Subscribe
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-002May 20, 2008ABRXYesNo► Subscribe► Subscribe ► Subscribe
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-003May 20, 2008ABRXYesYes► Subscribe► Subscribe ► Subscribe
Osmotica Pharm Corp
KHEDEZLA
desvenlafaxine
TABLET, EXTENDED RELEASE;ORAL204683-001Jul 10, 2013BCRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Osmotica

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-004May 20, 2008► Subscribe► Subscribe
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-001May 20, 2008► Subscribe► Subscribe
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-002May 20, 2008► Subscribe► Subscribe
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-003May 20, 2008► Subscribe► Subscribe
Osmotica Pharm
VENLAFAXINE HYDROCHLORIDE
venlafaxine hydrochloride
TABLET, EXTENDED RELEASE;ORAL022104-004May 20, 2008► Subscribe► Subscribe
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Non-Orange Book 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
6,274,171 Extended release formulation of venlafaxine hydrochloride► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Osmotica Drugs

Country Document Number Estimated Expiration
Hungary224617► Subscribe
Denmark1028718► Subscribe
Hungary9700589► Subscribe
South Africa9702403► Subscribe
European Patent Office2881110► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Osmotica Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1998Austria► SubscribePRODUCT 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/GB97/023United Kingdom► SubscribePRODUCT 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
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Cerilliant
Cipla
Harvard Business School
Chinese Patent Office
Covington
Citi
QuintilesIMS
Teva
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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