AYTU Company Profile

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AYTU has four approved drugs.

There are three US patents protecting AYTU drugs.

There are one hundred and five patent family members on AYTU drugs in sixteen countries and seven supplementary protection certificates in six countries.

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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
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-006	Feb 19, 2006	AB2	RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556-001	Mar 28, 2013		RX	Yes	Yes	8,062,667	⤷ Try a Trial	Y			⤷ Try a Trial
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-001	Mar 26, 2013		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Aytu	ZOLPIMIST	zolpidem tartrate	SPRAY, METERED;ORAL	022196-001	Dec 19, 2008		DISCN	Yes	No	8,236,285	⤷ Try a Trial	Y	Y		⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aytu	ZOLPIMIST	zolpidem tartrate	SPRAY, METERED;ORAL	022196-001	Dec 19, 2008	7,632,517	⤷ Try a Trial
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-003	May 27, 2003	6,344,215	⤷ Try a Trial
Aytu Biopharma	METADATE CD	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021259-001	Apr 3, 2001	6,344,215	⤷ Try a Trial
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-001	Mar 26, 2013	5,045,552*PED	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Extended-release Capsules	40 mg	➤ Subscribe	2007-03-15
➤ Subscribe	Extended-release Capsules	10 mg, 20 mg and 30 mg	➤ Subscribe	2005-05-13

Patent Number	Expiration Date
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Country	Patent Number	Estimated Expiration
China	102488652	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2004019904	⤷ Try a Trial
New Zealand	539285	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2004019909	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	92636	Luxembourg	⤷ Try a Trial	PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
0268956	SPC/GB98/040	United Kingdom	⤷ Try a Trial	PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508
2236132	C300714	Netherlands	⤷ Try a Trial	PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132	CA 2015 00004	Denmark	⤷ Try a Trial	PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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