DrugPatentWatch Database Preview
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 | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | RX | Yes | No | 8,574,626 | ➤ Sign Up | Y | ➤ 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 | HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205629-001 | 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 | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104-001 | May 20, 2008 | 6,419,958 | ➤ Sign Up |
| Osmotica Pharm | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104-002 | May 20, 2008 | 6,403,120 | ➤ Sign Up |
| Osmotica Pharm | VENLAFAXINE HYDROCHLORIDE | venlafaxine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022104-004 | May 20, 2008 | 6,403,120 | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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 | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Osmotica Drugs
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
Here is a list of applicants with similar names.
