AVANAFIL Drug Patent Profile
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When do Avanafil patents expire, and when can generic versions of Avanafil launch?
Avanafil is a drug marketed by Hetero Labs Ltd V and is included in one NDA.
The generic ingredient in AVANAFIL is avanafil. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the avanafil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Avanafil
A generic version of AVANAFIL was approved as avanafil by HETERO LABS LTD V on June 14th, 2024.
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Questions you can ask:
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Summary for AVANAFIL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 85 |
| Clinical Trials: | 24 |
| Patent Applications: | 1,696 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AVANAFIL |
| DailyMed Link: | AVANAFIL at DailyMed |
Recent Clinical Trials for AVANAFIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alexandria | Phase 4 |
| Johns Hopkins University | Phase 1/Phase 2 |
| Astellas Pharma US, Inc. | Phase 1/Phase 2 |
Pharmacology for AVANAFIL
| Drug Class | Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for AVANAFIL
US Patents and Regulatory Information for AVANAFIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hetero Labs Ltd V | AVANAFIL | avanafil | TABLET;ORAL | 209266-001 | Jun 14, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hetero Labs Ltd V | AVANAFIL | avanafil | TABLET;ORAL | 209266-002 | Jun 14, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hetero Labs Ltd V | AVANAFIL | avanafil | TABLET;ORAL | 209266-003 | Jun 14, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for AVANAFIL
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Menarini International Operations Luxembourg S.A. | Spedra | avanafil | EMEA/H/C/002581 Treatment of erectile dysfunction in adult men.In order for Spedra to be effective, sexual stimulation is required. |
Authorised | no | no | no | 2013-06-21 | 2013-04-26 |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
