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Osmotica Company Profile
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.
Summary for Osmotica
| US Patents: | 3 |
| Tradenames: | 9 |
| Ingredients: | 9 |
| NDAs: | 10 |
| Patent Litigation for Osmotica: | See patent lawsuits for Osmotica |
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 Corp | KHEDEZLA | desvenlafaxine | TABLET, EXTENDED RELEASE;ORAL | 204683-001 | Jul 10, 2013 | BC | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Osmotica | HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205629-001 | Jul 7, 2016 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-003 | Feb 16, 2018 | RX | Yes | Yes | RE39069 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Osmotica Pharm Us | NIFEDIPINE | nifedipine | TABLET, EXTENDED RELEASE;ORAL | 077410-001 | Oct 3, 2007 | AB2 | RX | No | No | ➤ Sign Up | ➤ Sign Up | ||||
| Osmotica | METHYLPHENIDATE HYDROCHLORIDE | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205327-001 | Jul 28, 2017 | AB | RX | No | 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 | ||||
| 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 | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-003 | Feb 16, 2018 | RE39069 | ➤ Sign Up |
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | RE39069 | ➤ Sign Up |
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | RE39069 | ➤ Sign Up |
| Osmotica Pharm | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104-004 | May 20, 2008 | 6,403,120 | ➤ Sign Up |
| Osmotica Pharm | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104-001 | 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 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for Osmotica Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Canada | 2261787 | ➤ Sign Up |
| Australia | 2005328058 | ➤ Sign Up |
| Australia | 7706598 | ➤ Sign Up |
| China | 1158071 | ➤ Sign Up |
| Japan | 2009517332 | ➤ Sign Up |
| Canada | 2589479 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Osmotica Drugs
| 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 |
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.
