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Generated: October 18, 2017
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.| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Clinical Trials: see list | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | DICLEGIS at DailyMed |
| Ingredient-type | Vitamin B 6 Analogs/Derivatives |
| Drug Class | Antihistamine Vitamin B6 Analog |
| Mechanism of Action | Histamine Receptor Antagonists |
| 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 | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||
Duchesnay | DICLEGIS | doxylamine succinate; pyridoxine hydrochloride | TABLET, DELAYED RELEASE;ORAL | 021876-001 | Apr 8, 2013 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| doxylamine succinate and pyridoxine hydrochloride | Delayed-release Tablets | 10 mg/10 mg | Diclegis | 8/1/2013 |
| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sweden | 526307 | ► Subscribe | |||||||||||||
| Denmark | 200200947 | ► Subscribe | |||||||||||||
| Ukraine | 74807 | ► Subscribe | |||||||||||||
| Japan | 4242763 | ► Subscribe | |||||||||||||
| South Korea | 100527985 | ► Subscribe | |||||||||||||
| Belgium | 1016043 | ► Subscribe | |||||||||||||
| Italy | UD20030145 | ► Subscribe | |||||||||||||
| Argentina | 034380 | ► Subscribe | |||||||||||||
| Spain | 2251494 | ► Subscribe | |||||||||||||
| Iceland | 6412 | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Serving leading biopharmaceutical companies globally:
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 verifification 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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