ACROTECH Company Profile

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ACROTECH has six approved drugs.

There are twelve US patents protecting ACROTECH drugs.

There are one hundred and seventy-nine patent family members on ACROTECH drugs in thirty-four countries and five supplementary protection certificates in four 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
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009		RX	Yes	No	8,299,078	⤷ Sign Up				⤷ Sign Up
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-002	Sep 24, 2009		RX	Yes	Yes	7,622,470	⤷ Sign Up				⤷ Sign Up
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes	9,493,582	⤷ Sign Up	Y			⤷ Sign Up
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	POWDER;INTRAVENOUS	020140-001	Mar 7, 2008		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Acrotech Biopharma	KHAPZORY	levoleucovorin	POWDER;INTRAVENOUS	211226-002	Oct 19, 2018		DISCN	Yes	No	11,541,012	⤷ Sign Up	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	6,723,338	⤷ Sign Up
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-002	Apr 29, 2011	6,500,829	⤷ Sign Up
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	5,543,152	⤷ Sign Up
Acrotech Biopharma	FUSILEV	levoleucovorin calcium	SOLUTION;INTRAVENOUS	020140-003	Apr 29, 2011	6,500,829	⤷ Sign Up
Acrotech Biopharma	FOLOTYN	pralatrexate	SOLUTION;INTRAVENOUS	022468-001	Sep 24, 2009	6,028,071	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Injection	20 mg/mL and 40 mg/2 mL	➤ Subscribe	2013-09-24
➤ Subscribe	Injection	50 mg/vial	➤ Subscribe	2017-09-08
➤ Subscribe	Injection	50 mg/vial	➤ Subscribe	2013-12-19
➤ Subscribe	Injection	500 mg/vial	➤ Subscribe	2018-07-03
➤ Subscribe	Injection	10 mg/mL, 17.5 mL vial and 25 mL vial	➤ Subscribe	2011-10-26

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	3/2023	Austria	⤷ Sign Up	PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818
2701720	122023000007	Germany	⤷ Sign Up	PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817
2701720	CA 2022 00054	Denmark	⤷ Sign Up	PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720	23C1000	France	⤷ Sign Up	PRODUCT NAME: MELPHALAN FLUFENAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/22/1669 20220818
2701720	CR 2022 00054	Denmark	⤷ Sign Up	PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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