DORAL Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Doral, and when can generic versions of Doral launch?
Doral is a drug marketed by Galt Pharms and is included in one NDA. There is one patent protecting this drug.
The generic ingredient in DORAL is quazepam. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the quazepam profile page.
DrugPatentWatch® Generic Entry Outlook for Doral
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 3, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
US Patents and Regulatory Information for DORAL
DORAL is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of DORAL is ⤷ Start Trial.
This potential generic entry date is based on patent 7,608,616.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-003 | Feb 26, 1987 | DISCN | No | No | 7,608,616 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | RX | Yes | Yes | 7,608,616 | ⤷ 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 |
International Patents for DORAL
See the table below for patents covering DORAL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 375931 | ⤷ Start Trial | |
| Austria | 381937 | ⤷ Start Trial | |
| Austria | A322880 | ⤷ Start Trial | |
| Austria | A574077 | ⤷ Start Trial | |
| Australia | 2751977 | ⤷ Start Trial | |
| Australia | 515628 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
