DORAL Drug Patent Profile
✉ Email this page to a colleague
When do Doral patents expire, 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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for DORAL?
- What are the global sales for DORAL?
- What is Average Wholesale Price for DORAL?
Summary for DORAL
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 22 |
| Patent Applications: | 3,511 |
| What excipients (inactive ingredients) are in DORAL? | DORAL excipients list |
| DailyMed Link: | DORAL at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DORAL
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting DORAL
Methods for reducing the risk of an adverse drug interaction in a patient suffering from insomnia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD FOR TREATING INSOMNIA WHILE REDUCING THE RISK OF AN ADVERSE DRUG INTERACTION
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | RX | Yes | Yes | ⤷ Sign Up | ⤷ 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 DORAL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-003 | Feb 26, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| Galt Pharms | DORAL | quazepam | TABLET;ORAL | 018708-001 | Dec 27, 1985 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DORAL
See the table below for patents covering DORAL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 7595581 | ⤷ Sign Up | |
| New Zealand | 198522 | FORM 2 RANITIDINE HYDROCHLORIDE:THE HYDROCHLORIC SALT OF N-(2-(((5-(DIMETHYLAMINO)METHYL)-2-FURANYL)METHYL)-THIO)ETHYL-N1-METHYL-2-NITRO-1,1-ETHENEDIAMINE | ⤷ Sign Up |
| Finland | 80687 | ⤷ Sign Up | |
| Kenya | 3080 | AMINOALKYL FURAN DERIVATIVES | ⤷ Sign Up |
| Italy | 1214661 | TIOLI COME INTERMEDI NELLE PREPARAZIONE DI AGENTI SELETTIVI SUI RICETTORI ISTAMINICI E PROCEDIMENTO PER LA PRODUZIONE DI DETTI TIOLI | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
