Edenbridge Pharms Company Profile

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EDENBRIDGE PHARMS has thirteen approved drugs.

There are ten US patents protecting EDENBRIDGE PHARMS drugs.

There are forty-nine patent family members on EDENBRIDGE PHARMS drugs in thirty-two countries and thirty-three supplementary protection certificates in fifteen 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
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-003	Dec 11, 2014		RX	Yes	No	8,658,198	⤷ Start Trial	Y			⤷ Start Trial
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015		RX	Yes	No	8,470,361	⤷ Start Trial	Y			⤷ Start Trial
Edenbridge Pharms	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	TABLET;ORAL	211596-001	Nov 18, 2019		DISCN	No	No		⤷ Start Trial				⤷ Start 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
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-003	Dec 11, 2014	8,454,996	⤷ Start Trial
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-006	Oct 4, 2016	8,454,996	⤷ Start Trial
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-001	Jul 3, 2013	8,454,996	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Sublingual Tablets	1.4 mg/0.36 mg and 5.7 mg/1.4 mg	➤ Subscribe	2013-10-22
➤ Subscribe	Sublingual Tablets	2.9 mg/7.1 mg	➤ Subscribe	2015-12-21
➤ Subscribe	Sublingual Tablets	8.6 mg/2.1 mg and 11.4 mg/2.9 mg	➤ Subscribe	2015-07-24
➤ Subscribe	Sublingual tablets	0.7 mg/0.18 mg	➤ Subscribe	2017-05-03

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	2021C/518	Belgium	⤷ Start Trial	PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
2435025	201940030	Slovenia	⤷ Start Trial	PRODUCT NAME: COMBINATION OF GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, ENANTIOMERES) AND FORMOTEROLE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, ENANTIOMERES); NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF NATIONAL AUTHORISATION: 20181218; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2435025	1990034-9	Sweden	⤷ Start Trial	PRODUCT NAME: A COMBINATION OF GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALT OR ESTERS THEREOF AND FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS OR ESTERS THEREOF.; REG. NO/DATE: EU/1/18/1339 20181220
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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