DrugPatentWatch Database Preview
DICLEGIS Drug Profile
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.
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 GmbH | Phase 1 |
| Grünenthal, S.A. | Phase 1 |
| Duchesnay Inc. | 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 |
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 Pricing | See Pricing | Y | See Pricing | ||
| Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876-001 | Apr 8, 2013 | AB | RX | Yes | Yes | See Pricing | See Pricing | Y | See 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 Pricing | See Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for DICLEGIS
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Delayed-release Tablets | 10 mg/10 mg | ➤ Subscribe | See Pricing |
International Patents for DICLEGIS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Belgium | 1016043 | See Pricing |
| Monaco | 200066 | See Pricing |
| Canada | 2392486 | See Pricing |
| Greece | 1004371 | See Pricing |
| Japan | 2004521146 | See Pricing |
| Denmark | 1397133 | See Pricing |
| Uruguay | 27352 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
