Avanafil - Generic Drug Details

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What are the generic drug sources for avanafil and what is the scope of patent protection?

Avanafil is the generic ingredient in one branded drug marketed by Metuchen Pharms and is included in one NDA. 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. One supplier is listed for this compound.

Summary for avanafil

International Patents:	41
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	24
Patent Applications:	2,839
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for avanafil

Generic Entry Date for avanafil^: ⤷ Sign Up* 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.

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

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		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-001	Apr 27, 2012		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-002	Apr 27, 2012		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-003	Apr 27, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-002	Apr 27, 2012		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-001	Apr 27, 2012		RX	Yes	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	202276-002	Apr 27, 2012	⤷ Sign Up	⤷ Sign Up
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-003	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
World Intellectual Property Organization (WIPO)	0183460		⤷ Sign Up
Canada	2407231		⤷ Sign Up
Canada	2383466	COMPOSES CYCLIQUES AROMATIQUES AZOTES A SIX ELEMENTS (AROMATIC NITROGEN-CONTAINING 6-MEMBERED CYCLIC COMPOUNDS)	⤷ Sign Up
Australia	767558		⤷ Sign Up
Turkey	200200701		⤷ Sign Up
Russian Federation	2233273	АРОМАТИЧЕСКИЕ АЗОТСОДЕРЖАЩИЕ 6-ЧЛЕННЫЕ ЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ	⤷ Sign Up
World Intellectual Property Organization (WIPO)	0119802		⤷ 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	2013/041	Ireland	⤷ Sign Up	PRODUCT NAME: AVANAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/841 20130613
1219609	92249	Luxembourg	⤷ Sign Up	PRODUCT NAME: AVANAFIL
1219609	C300618	Netherlands	⤷ Sign Up	PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609	1390047-7	Sweden	⤷ Sign Up	PRODUCT NAME: AVANAFIL; REG. NO/DATE: EU/1/13/841 20130621
1219609	SPC/GB13/071	United Kingdom	⤷ Sign Up	PRODUCT NAME: AVANAFIL; REGISTERED: UK EU/1/13/841 20130621
1219609	2013C/051	Belgium	⤷ Sign Up	PRODUCT NAME: AVANAFIL; AUTHORISATION NUMBER AND DATE: EU/1/13/841 20130624
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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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.