Pharsight

1. Androgel patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP06836341A	2013-08-21	Oser, Andreas	Opposition rejected

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9132089	BESINS HLTHCARE	Pharmaceutical composition and method for treating hypogonadism	Aug, 2020 (3 years ago)
US9125816	BESINS HLTHCARE	Pharmaceutical composition and method for treating hypogonadism	Aug, 2020 (3 years ago)
US6503894	BESINS HLTHCARE	Pharmaceutical composition and method for treating hypogonadism	Aug, 2020 (3 years ago)
US6503894 (Pediatric)	BESINS HLTHCARE	Pharmaceutical composition and method for treating hypogonadism	Mar, 2021 (3 years ago)
US9125816 (Pediatric)	BESINS HLTHCARE	Pharmaceutical composition and method for treating hypogonadism	Mar, 2021 (3 years ago)
US9132089 (Pediatric)	BESINS HLTHCARE	Pharmaceutical composition and method for treating hypogonadism	Mar, 2021 (3 years ago)
US8446138	BESINS HLTHCARE	Stability compensation circuit and DC-DC converter including the same	Oct, 2026 (2 years from now)
US8466138	BESINS HLTHCARE	Testosterone gel and method of use	Oct, 2026 (2 years from now)
US8754070	BESINS HLTHCARE	Testosterone gel and method of use	Oct, 2026 (2 years from now)
US8729057	BESINS HLTHCARE	Testosterone gel and method of use	Oct, 2026 (2 years from now)
US8759329	BESINS HLTHCARE	Testosterone gel and method of use	Oct, 2026 (2 years from now)
US8486925	BESINS HLTHCARE	Testosterone gel and method of use	Oct, 2026 (2 years from now)
US8466136	BESINS HLTHCARE	Testosterone gel and method of use	Oct, 2026 (2 years from now)
US8741881	BESINS HLTHCARE	Testosterone gel and method of use	Oct, 2026 (2 years from now)
US8466137	BESINS HLTHCARE	Testosterone gel and method of use	Oct, 2026 (2 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Apr 29, 2014

Market Authorisation Date: 29 April, 2011

Treatment: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

Dosage: GEL, METERED;TRANSDERMAL; GEL;TRANSDERMAL

Strength	Dosage	Availability
1.62% (20.25MG/1.25GM ACTUATION)	GEL, METERED;TRANSDERMAL	Prescription
12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL, METERED;TRANSDERMAL	Discontinued
50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL;TRANSDERMAL	Discontinued
25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL;TRANSDERMAL	Discontinued
1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL;TRANSDERMAL	Discontinued
1.62% (20.25MG/1.25GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL;TRANSDERMAL	Discontinued

ANDROGEL family patents

2. Axiron patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP06741180A	2017-08-09	Müller Fottner Steinecke Rechtsanwalts- und Patentanwaltspartnerschaft mbB	Revoked
EP03729716A	2017-04-26	Müller Fottner Steinecke Rechtsanwalts- und Patentanwaltspartnerschaft mbB	Revoked

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8071075	ELI LILLY AND CO	Dermal penetration enhancers and drug delivery systems involving the same	Feb, 2017 (7 years ago)
US6299900	ELI LILLY AND CO	Dermal penetration enhancers and drug delivery systems involving same	Feb, 2017 (7 years ago)
US6923983	ELI LILLY AND CO	Transdermal delivery of hormones	Feb, 2017 (7 years ago)
US6818226	ELI LILLY AND CO	Dermal penetration enhancers and drug delivery systems involving same	Feb, 2017 (7 years ago)
US8784878	ELI LILLY AND CO	Transdermal delivery rate control using amorphous pharmaceutical compositions	Jul, 2023 (9 months ago)
US8993520	ELI LILLY AND CO	Method and composition for transdermal drug delivery	Jun, 2026 (2 years from now)
US9180194	ELI LILLY AND CO	Method and composition for transdermal drug delivery	Jun, 2026 (2 years from now)
US8807861	ELI LILLY AND CO	Spreading implement	Feb, 2027 (2 years from now)
US9289586	ELI LILLY AND CO	Spreading implement	Feb, 2027 (2 years from now)
US8419307	ELI LILLY AND CO	Spreading implement	Feb, 2027 (2 years from now)
US8435944	ELI LILLY AND CO	Method and composition for transdermal drug delivery	Sep, 2027 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Nov 23, 2013

Market Authorisation Date: 23 November, 2010

Treatment: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone; A method of transdermally delivering testosterone; A method of increasing t...

Dosage: SOLUTION, METERED;TRANSDERMAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
30 mg/1.5 mL	29 Jan, 2013	1	07 Aug, 2017	19 Feb, 2017	Extinguished

Strength	Dosage	Availability
30MG/1.5ML ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION, METERED;TRANSDERMAL	Discontinued

AXIRON family patents

3. Fortesta patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6579865	ENDO PHARMS	Penetration enhancing and irritation reducing systems	Nov, 2018 (5 years ago)
US6319913	ENDO PHARMS	Penetration enhancing and irritation reducing systems	Nov, 2018 (5 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Dec 29, 2013

Market Authorisation Date: 29 December, 2010

Treatment: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

Dosage: GEL, METERED;TRANSDERMAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
10 mg/actuation	14 Aug, 2012	1	05 Aug, 2015	09 Nov, 2018	Deferred

Strength	Dosage	Availability
10MG/0.5GM ACTUATION	GEL, METERED;TRANSDERMAL	Prescription

FORTESTA family patents

4. Natesto patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8784882	ACERUS	Controlled release delivery system for nasal applications and method of treatment	Feb, 2024 (2 months ago)
US8574622	ACERUS	Controlled release delivery system for nasal applications	Feb, 2024 (2 months ago)
US8877230	ACERUS	Controlled release delivery system for nasal applications	Feb, 2024 (2 months ago)
US8784869	ACERUS	Controlled release delivery system for nasal applications and methods of treatment	Feb, 2024 (2 months ago)
US11090312	ACERUS	Methods of treating hypogonadism with transnasal testerosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event	Mar, 2034 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	May 28, 2017

Market Authorisation Date: 28 May, 2014

Treatment: A method of testosterone replacement therapy comprising the step of nasally administering to a patient in need of such treatment an effective amount of testosterone gel formulation.; Nasal administrat...

Dosage: GEL, METERED;NASAL

Strength	Dosage	Availability
5.5MG/0.122GM ACTUATION	GEL, METERED;NASAL	Prescription

NATESTO family patents

5. Striant patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6248358	AUXILIUM PHARMS LLC	Bioadhesive progressive hydration tablets and methods of making and using the same	Aug, 2019 (4 years ago)

Market Authorisation Date: 19 June, 2003

Treatment: Method of delivering an active ingredient using a progressive hydration bioadhesive

Dosage: TABLET, EXTENDED RELEASE;BUCCAL

Strength	Dosage	Availability
30MG	TABLET, EXTENDED RELEASE;BUCCAL	Discontinued

STRIANT family patents

6. Testim patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8178518	AUXILIUM PHARMS LLC	Pharmaceutical composition	Apr, 2023 (1 year, 5 days ago)
US7608608	AUXILIUM PHARMS LLC	Pharmaceutical composition	Apr, 2023 (1 year, 5 days ago)
US7608610	AUXILIUM PHARMS LLC	Pharmaceutical composition	Apr, 2023 (1 year, 5 days ago)
US7608606	AUXILIUM PHARMS LLC	Pharmaceutical composition	Apr, 2023 (1 year, 5 days ago)
US8063029	AUXILIUM PHARMS LLC	Pharmaceutical composition	Apr, 2023 (1 year, 5 days ago)
US7608605	AUXILIUM PHARMS LLC	Pharmaceutical composition	Apr, 2023 (1 year, 5 days ago)
US7608607	AUXILIUM PHARMS LLC	Pharmaceutical composition	Apr, 2023 (1 year, 5 days ago)
US7608609	AUXILIUM PHARMS LLC	Pharmaceutical composition	Apr, 2023 (1 year, 5 days ago)
US7935690	AUXILIUM PHARMS LLC	Pharmaceutical composition	Apr, 2023 (1 year, 5 days ago)
US7320968	AUXILIUM PHARMS LLC	Pharmaceutical composition	Jan, 2025 (8 months from now)

Market Authorisation Date: 31 October, 2002

Treatment: Method for administration of testosterone

Dosage: GEL;TRANSDERMAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.01	21 Aug, 2008	1		11 Jun, 2008	Extinguished

Strength	Dosage	Availability
50MG/5GM PACKET	GEL;TRANSDERMAL	Prescription

TESTIM family patents

7. Testoderm patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5840327	ALZA	Transdermal drug delivery device having enhanced adhesion	Aug, 2016 (7 years ago)

Market Authorisation Date: 12 October, 1993

Treatment: NA

Dosage: FILM, EXTENDED RELEASE;TRANSDERMAL

Strength	Dosage	Availability
6MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued
4MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Discontinued

TESTODERM family patents

8. Testoderm Tts patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6348210	ALZA	Methods for transdermal drug administration	Nov, 2019 (4 years ago)

Market Authorisation Date: 18 December, 1997

Treatment: Method for transdermal administration of a drug through non-scrotal skin using a transdermal drug delivery device containing the drug and having an adhesive surface