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. Two 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: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DICLEGIS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DICLEGIS |
| DailyMed Link: | DICLEGIS at DailyMed |
Pharmacology for DICLEGIS
| Ingredient-type | Vitamin B 6 Analogs/Derivatives |
| Drug Class | Antihistamine Vitamin B6 Analog |
| Mechanism of Action | Histamine Receptor Antagonists |
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 | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876-001 | Apr 8, 2013 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ 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 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 | ➤ Sign Up | ➤ Sign Up |
| 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 | ➤ Sign Up |
International Patents for DICLEGIS
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Hungary | 0301950 | ➤ Sign Up |
| Uruguay | 27352 | ➤ Sign Up |
| Brazil | 0107371 | ➤ Sign Up |
| Monaco | 200059 | ➤ Sign Up |
| Greece | 20020100280 | ➤ Sign Up |
| South Korea | 20030023612 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
