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DICLEGIS Drug Profile
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Which patents cover Diclegis, and when can generic versions of Diclegis launch?
Diclegis is a drug marketed by Duchesnay and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-two patent family members in thirty-seven countries.
The generic ingredient in DICLEGIS is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Diclegis
Diclegis was eligible for patent challenges on December 31st, 1968.
Annual sales in 2017 were $269mm indicating the motivation for generic entry.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Summary for DICLEGIS
| International Patents: | 62 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 2 |
| Clinical Trials: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DICLEGIS |
| Drug Sales Revenues: | Drug sales revenues for DICLEGIS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DICLEGIS |
| DailyMed Link: | DICLEGIS at DailyMed |
Recent Clinical Trials for DICLEGIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Grünenthal, S.A. | Phase 1 |
| Grünenthal GmbH | Phase 1 |
| Premier Research Group plc | Phase 4 |
Recent Litigation for DICLEGIS
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Duchesnay Inc. v. Mylan Pharmaceuticals Inc. | 2015-05-13 |
| Duchesnay Inc. v. Actavis Inc. |
Pharmacology for DICLEGIS
| Ingredient-type | Vitamin B 6 Analogs/Derivatives |
| Drug Class | Antihistamine Vitamin B6 Analog |
| Mechanism of Action | Histamine Receptor Antagonists |
Synonyms for DICLEGIS
| 4,5-bis(hydroxymethyl)-2-methylpyridin-3-ol; butanedioic acid; N,N-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine; hydrochloride |
| 99007-20-2 |
| AC1L4TES |
| Butanedioic acid, compd. with N,N-dimethyl-2-(1-phenyl-1-(2-pyridinyl)ethoxy)ethanamine (1:1), mixt. with 5-hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride |
| Butanedioic acid, compd. with N,N-dimethyl-2-(1-phenyl-1-(2-pyridinyl)ethoxy)ethanamine (1:1),mixt. with 5-hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride |
| Diclectin |
| Doxylamine / pyridoxine |
| Doxylamine mixture with pyridoxine |
| Doxylamine succinate / pyridoxine hydrochloride |
| Doxylamine succinate mixture with pyridoxine hydrochloride |
| LS-45739 |
Paragraph IV (Patent) Challenges for DICLEGIS
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| DICLEGIS | TABLET, DELAYED RELEASE;ORAL | doxylamine succinate; pyridoxine hydrochloride | 021876 | 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 | Start Trial | Start Trial | Y | Start Trial | ||
| Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876-001 | Apr 8, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DICLEGIS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Ireland | 20020488 | Start Trial |
| Japan | 4242763 | Start Trial |
| Norway | 20022982 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
