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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 nine approved drugs.
There are eight US patents protecting OSMOTICA drugs.
There are eleven patent family members on OSMOTICA drugs in nine countries and two supplementary protection certificates in two countries.
Summary for Osmotica
| International Patents: | 11 |
| US Patents: | 8 |
| Tradenames: | 9 |
| Ingredients: | 9 |
| NDAs: | 9 |
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 Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-003 | Feb 16, 2018 | RX | Yes | Yes | 10,500,171 | Start Trial | 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 | 209410-002 | Feb 16, 2018 | RX | Yes | No | 8,252,331 | Start Trial | Y | Start Trial | |||
| Osmotica Pharm Us | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 077127-001 | Nov 21, 2005 | AB2 | RX | No | No | Start Trial | Start Trial | ||||
| Osmotica Pharm Us | DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 203114-001 | Jan 26, 2016 | DISCN | No | No | 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 |
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 | 022104-001 | May 20, 2008 | 6,419,958 | 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 | 022104-002 | May 20, 2008 | 6,403,120 | Start Trial |
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | RE39069 | Start Trial |
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | RE39069 | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for Osmotica Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2589479 | Start Trial |
| Australia | 2005328058 | Start Trial |
| Spain | 2549581 | Start Trial |
| European Patent Office | 1834638 | Start Trial |
| Mexico | 2007006472 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Osmotica Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
