Details for New Drug Application (NDA): 205649
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NDA 205649 describes XIGDUO XR, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and two Paragraph IV challenges. Additional details are available on the XIGDUO XR profile page.
The generic ingredient in XIGDUO XR is dapagliflozin; metformin hydrochloride. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride profile page.
The generic ingredient in XIGDUO XR is dapagliflozin; metformin hydrochloride. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride profile page.
Summary for 205649
| Tradename: | XIGDUO XR |
| Applicant: | Astrazeneca Ab |
| Ingredient: | dapagliflozin; metformin hydrochloride |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205649
Generic Entry Date for 205649*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 205649
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 205649
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6225 | 0310-6225-60 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6225-60) |
| XIGDUO XR | dapagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205649 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6250 | 0310-6250-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6250-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG;500MG | ||||
| Approval Date: | Oct 29, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 12, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Dec 12, 2027 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | 6,515,117*PED | Patent Expiration: | Apr 4, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 205649
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