STENDRA Drug Patent Profile
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Which patents cover Stendra, and what generic alternatives are available?
Stendra is a drug marketed by Metuchen Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has forty-one patent family members in twenty-five countries.
The generic ingredient in STENDRA 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 Stendra
A generic version of STENDRA was approved as avanafil by HETERO LABS LTD V on June 14th, 2024.
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Summary for STENDRA
| International Patents: | 41 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 84 |
| Clinical Trials: | 6 |
| Patent Applications: | 1,696 |
| Drug Prices: | Drug price information for STENDRA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for STENDRA |
| What excipients (inactive ingredients) are in STENDRA? | STENDRA excipients list |
| DailyMed Link: | STENDRA at DailyMed |
Recent Clinical Trials for STENDRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| VIVUS, Inc. | Phase 4 |
| VIVUS, Inc. | Phase 3 |
Pharmacology for STENDRA
| Drug Class | Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
US Patents and Regulatory Information for STENDRA
STENDRA is protected by one US patents and one FDA Regulatory Exclusivity.
Patents protecting STENDRA
Aromatic nitrogen-containing 6-membered cyclic compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ERECTILE DYSFUNCTION
FDA Regulatory Exclusivity protecting STENDRA
REVISIONS TO THE LABELING TO ADD THE RESULTS OF A CLINICAL STUDY (TA-303) IN PATIENTS WITH ED FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Metuchen Pharms | STENDRA | avanafil | TABLET;ORAL | 202276-001 | Apr 27, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | |
| Metuchen Pharms | STENDRA | avanafil | TABLET;ORAL | 202276-002 | Apr 27, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Metuchen Pharms | STENDRA | avanafil | TABLET;ORAL | 202276-001 | Apr 27, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Metuchen Pharms | STENDRA | avanafil | TABLET;ORAL | 202276-002 | Apr 27, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | |
| Metuchen Pharms | STENDRA | avanafil | TABLET;ORAL | 202276-003 | Apr 27, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Metuchen Pharms | STENDRA | avanafil | TABLET;ORAL | 202276-003 | Apr 27, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for STENDRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Metuchen Pharms | STENDRA | avanafil | TABLET;ORAL | 202276-001 | Apr 27, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Metuchen Pharms | STENDRA | avanafil | TABLET;ORAL | 202276-003 | Apr 27, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Metuchen Pharms | STENDRA | avanafil | TABLET;ORAL | 202276-002 | Apr 27, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for STENDRA
| 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 |
International Patents for STENDRA
See the table below for patents covering STENDRA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 552013 | ⤷ Sign Up | |
| Spain | 2283315 | ⤷ Sign Up | |
| Russian Federation | 2233273 | АРОМАТИЧЕСКИЕ АЗОТСОДЕРЖАЩИЕ 6-ЧЛЕННЫЕ ЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ | ⤷ Sign Up |
| Bulgaria | 106566 | ⤷ Sign Up | |
| China | 1440393 | ⤷ Sign Up | |
| European Patent Office | 1219609 | COMPOSES CYCLIQUES AROMATIQUES AZOTES A SIX ELEMENTS (AROMATIC NITROGENOUS SIX-MEMBERED RING COMPOUNDS) | ⤷ Sign Up |
| Australia | 2001241142 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for STENDRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1219609 | 122013000096 | Germany | ⤷ Sign Up | PRODUCT NAME: AVANAFIL UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/841 20130621 |
| 1219609 | C300618 | Netherlands | ⤷ Sign Up | PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621 |
| 1219609 | C01219609/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: SWISSMEDIC 65275 22.01.2016 |
| 1219609 | 1390047-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: AVANAFIL; REG. NO/DATE: EU/1/13/841 20130621 |
| 1219609 | 2013C/051 | Belgium | ⤷ Sign Up | PRODUCT NAME: AVANAFIL; AUTHORISATION NUMBER AND DATE: EU/1/13/841 20130624 |
| 1219609 | 476 | Finland | ⤷ Sign Up | |
| 1219609 | CA 2013 00040 | Denmark | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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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