Details for New Drug Application (NDA): 202813
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NDA 202813 describes QNASL, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the QNASL profile page.
The generic ingredient in QNASL is beclomethasone dipropionate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the beclomethasone dipropionate profile page.
The generic ingredient in QNASL is beclomethasone dipropionate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the beclomethasone dipropionate profile page.
Summary for 202813
| Tradename: | QNASL |
| Applicant: | Teva Branded Pharm |
| Ingredient: | beclomethasone dipropionate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202813
Generic Entry Date for 202813*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, METERED;NASAL |
*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: 202813
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 202813
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QNASL | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 202813 | NDA | Teva Respiratory, LLC | 59310-406 | 59310-406-06 | 1 INHALER in 1 CARTON (59310-406-06) / 60 AEROSOL, METERED in 1 INHALER |
| QNASL | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 202813 | NDA | Teva Respiratory, LLC | 59310-406 | 59310-406-08 | 1 INHALER in 1 CARTON (59310-406-08) / 60 AEROSOL, METERED in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;NASAL | Strength | 0.08MG/ACTUATION | ||||
| Approval Date: | Mar 23, 2012 | TE: | RLD: | Yes | |||||
| Patent: | 10,188,811 | Patent Expiration: | Oct 21, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 7,780,038 | Patent Expiration: | Jan 24, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;NASAL | Strength | 0.04MG/ACTUATION | ||||
| Approval Date: | Dec 17, 2014 | TE: | RLD: | Yes | |||||
| Patent: | 10,188,811 | Patent Expiration: | Oct 21, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 202813
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | QNASL | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 202813-001 | Mar 23, 2012 | 5,776,432 | ⤷ Subscribe |
| Teva Branded Pharm | QNASL | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 202813-002 | Dec 17, 2014 | 5,776,432 | ⤷ Subscribe |
| Teva Branded Pharm | QNASL | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 202813-001 | Mar 23, 2012 | 5,683,677 | ⤷ Subscribe |
| Teva Branded Pharm | QNASL | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 202813-001 | Mar 23, 2012 | 5,605,674 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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