AVANAFIL - Generic Drug Details

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What are the generic drug sources for avanafil and what is the scope of freedom to operate?

Avanafil is the generic ingredient in two branded drugs marketed by Hetero Labs Ltd V and Metuchen Pharms, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Avanafil has forty-one patent family members in twenty-five countries.

There are five drug master file entries for avanafil. Two suppliers are listed for this compound.

Summary for AVANAFIL

International Patents:	41
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	24
Patent Applications:	2,646
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVANAFIL
What excipients (inactive ingredients) are in AVANAFIL?	AVANAFIL excipients list
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
Astellas Pharma US, Inc.	Phase 1/Phase 2
Johns Hopkins University	Phase 1/Phase 2

See all AVANAFIL clinical trials

Pharmacology for AVANAFIL

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AVANAFIL

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for AVANAFIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STENDRA	Tablets	avanafil	50 mg, 100 mg and 200 mg	202276	1	2016-04-27

US Patents and Regulatory Information for AVANAFIL

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Glossary

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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	202276-003	Apr 27, 2012	AB	RX	Yes	Yes	⤷ 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	Y	Y		⤷ 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
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-001	Apr 27, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Hetero Labs Ltd V	AVANAFIL	avanafil	TABLET;ORAL	209266-001	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

Expired US Patents for AVANAFIL

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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 AVANAFIL

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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 AVANAFIL

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Country	Patent Number	Title	Estimated Expiration
Norway	2013018		⤷ Sign Up
Brazil	0014526	compostos cíclicos de seis elementos contendo nitrogênio aromático, composição farmacêutica e uso do mesmo	⤷ Sign Up
Norway	322038		⤷ Sign Up
Australia	767558		⤷ Sign Up
Bulgaria	65453		⤷ Sign Up
Austria	358670		⤷ Sign Up
Germany	60034239		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for AVANAFIL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1219609	2013C/051	Belgium	⤷ Sign Up	PRODUCT NAME: AVANAFIL; AUTHORISATION NUMBER AND DATE: EU/1/13/841 20130624
1219609	C01219609/01	Switzerland	⤷ Sign Up	PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: SWISSMEDIC 65275 22.01.2016
1219609	2013/041	Ireland	⤷ Sign Up	PRODUCT NAME: AVANAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/841 20130613
1219609	476	Finland	⤷ Sign Up
1219609	CA 2013 00040	Denmark	⤷ Sign Up
1219609	C300618	Netherlands	⤷ Sign Up	PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609	13C0050	France	⤷ Sign Up	PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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