DICLEGIS Drug Patent Profile
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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: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 4 |
| Clinical Trials: | 2 |
| Patent Applications: | 10 |
| 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 |
| Duchesnay Inc. | Phase 4 |
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| >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 | See Plans and Pricing | See Plans and Pricing |
| Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876-001 | Apr 8, 2013 | See Plans and Pricing | See Plans and Pricing |
| >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 |
|---|---|---|---|
| Belgium | 1014929 | FORMULATION A DELAI D'ACTION RAPIDE. | See Plans and Pricing |
| Finland | 20021708 | See Plans and Pricing | |
| Monaco | 200066 | Forme posologique pharmaceutique portant une signalétique indiquant une parfaite innocuité en cas degrossesse | See Plans and Pricing |
| Norway | 332190 | See Plans and Pricing | |
| European Patent Office | 1397133 | FORME GALENIQUE A COURT DELAI D'ACTION (RAPID ONSET FORMULATION) | See Plans and Pricing |
| Taiwan | 200400835 | Pharmaceutical dosage form bearing pregnancy-friendly indicia | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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