DICLEGIS Drug Patent Profile
✉ Email this page to a colleague
When do Diclegis patents expire, and when can generic versions of Diclegis launch?
Diclegis is a drug marketed by Duchesnay and is included in one NDA.
The generic ingredient in DICLEGIS is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Diclegis
A generic version of DICLEGIS was approved as doxylamine succinate; pyridoxine hydrochloride by ACTAVIS LABS FL INC on August 19th, 2016.
Summary for DICLEGIS
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Clinical Trials: | 2 |
Patent Applications: | 8 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for DICLEGIS |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DICLEGIS |
What excipients (inactive ingredients) are in DICLEGIS? | DICLEGIS excipients list |
DailyMed Link: | DICLEGIS at DailyMed |



Recent Clinical Trials for DICLEGIS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Grünenthal GmbH | Phase 1 |
Grünenthal, S.A. | Phase 1 |
Premier Research Group plc | Phase 4 |
Pharmacology for DICLEGIS
Ingredient-type | Analogs/Derivatives Vitamin B 6 |
Drug Class | Antihistamine Vitamin B6 Analog |
Mechanism of Action | Histamine Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for DICLEGIS
Paragraph IV (Patent) Challenges for DICLEGIS
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
DICLEGIS | Delayed-release Tablets | doxylamine succinate; pyridoxine hydrochloride | 10 mg/10 mg | 021876 | 1 | 2013-08-01 |
US Patents and Regulatory Information for DICLEGIS
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876-001 | Apr 8, 2013 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 DICLEGIS
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876-001 | Apr 8, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876-001 | Apr 8, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DICLEGIS
See the table below for patents covering DICLEGIS around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Luxembourg | 90934 | Formulation à délai d'action rapide | ⤷ Try a Trial |
Israel | 150349 | ⤷ Try a Trial | |
Denmark | 200200947 | ⤷ Try a Trial | |
Uruguay | 27352 | FORMULACION DE INICIACION RÁPIDA | ⤷ Try a Trial |
Denmark | 1397133 | ⤷ Try a Trial | |
Iceland | 2225 | ⤷ Try a Trial | |
Taiwan | 200400835 | Pharmaceutical dosage form bearing pregnancy-friendly indicia | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |