Details for New Drug Application (NDA): 202276
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NDA 202276 describes STENDRA, which is a drug marketed by Metuchen Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the STENDRA profile page.
The generic ingredient in STENDRA is avanafil. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the avanafil profile page.
The generic ingredient in STENDRA is avanafil. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the avanafil profile page.
Summary for 202276
| Tradename: | STENDRA |
| Applicant: | Metuchen Pharms |
| Ingredient: | avanafil |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202276
Generic Entry Date for 202276*:
Constraining patent/regulatory exclusivity:
REVISIONS TO THE LABELING TO ADD THE RESULTS OF A CLINICAL STUDY (TA-303) IN PATIENTS WITH ED FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY Dosage:
TABLET;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: 202276
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Suppliers and Packaging for NDA: 202276
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| STENDRA | avanafil | TABLET;ORAL | 202276 | NDA | Metuchen Pharmaceuticals, LLC | 72384-751 | 72384-751-30 | 30 TABLET in 1 BOTTLE (72384-751-30) |
| STENDRA | avanafil | TABLET;ORAL | 202276 | NDA | Metuchen Pharmaceuticals, LLC | 72384-752 | 72384-752-30 | 30 TABLET in 1 BOTTLE (72384-752-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Apr 27, 2012 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 18, 2025 | ||||||||
| Regulatory Exclusivity Use: | REVISIONS TO THE LABELING TO ADD THE RESULTS OF A CLINICAL STUDY (TA-303) IN PATIENTS WITH ED FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 27, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF ERECTILE DYSFUNCTION | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Apr 27, 2012 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 18, 2025 | ||||||||
| Regulatory Exclusivity Use: | REVISIONS TO THE LABELING TO ADD THE RESULTS OF A CLINICAL STUDY (TA-303) IN PATIENTS WITH ED FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY | ||||||||
Expired US Patents for NDA 202276
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Metuchen Pharms | STENDRA | avanafil | TABLET;ORAL | 202276-003 | Apr 27, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Metuchen Pharms | STENDRA | avanafil | TABLET;ORAL | 202276-002 | Apr 27, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| Metuchen Pharms | STENDRA | avanafil | TABLET;ORAL | 202276-001 | Apr 27, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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