Twi Pharms Company Profile

What is the competitive landscape for TWI PHARMS, and what generic alternatives to TWI PHARMS drugs are available?

TWI PHARMS has twenty-nine approved drugs.

There is one US patent protecting TWI PHARMS drugs. There is one tentative approval on TWI PHARMS drugs.

There is one patent family member on TWI PHARMS drugs in one country and one hundred and twenty-eight supplementary protection certificates in sixteen countries.

Summary for Twi Pharms

International Patents:	1
US Patents:	1
Tradenames:	26
Ingredients:	23
NDAs:	29

Drugs and US Patents for Twi Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Twi Pharms	FLUPHENAZINE HYDROCHLORIDE	fluphenazine hydrochloride	TABLET;ORAL	215848-004	Dec 14, 2022	AB	RX	No	No
Twi Pharms	FORFIVO XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022497-001	Nov 10, 2011		RX	Yes	Yes	7,674,479		Y
Twi Pharms	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION;TOPICAL	202393-001	Nov 24, 2014		DISCN	No	No
Twi Pharms	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	CAPSULE;ORAL	217054-001	Dec 27, 2022	AB	RX	No	No
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Twi Pharms	ATENOLOL	atenolol	TABLET;ORAL	072304-003	Jul 18, 1988	AB	RX	No	No
Twi Pharms	DILTIAZEM HYDROCHLORIDE	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	217377-001	Mar 1, 2023	AB1	RX	No	No

Expired US Patents for Twi Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Twi Pharms	ZESTRIL	lisinopril	TABLET;ORAL	019777-004	May 19, 1988	4,374,829*PED
Twi Pharms	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	3,934,032
Twi Pharms	TENORETIC 50	atenolol; chlorthalidone	TABLET;ORAL	018760-002	Jun 8, 1984	3,663,607
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-003	Jan 5, 1996	5,637,320
Twi Pharms	TENORMIN	atenolol	TABLET;ORAL	018240-002	Approved Prior to Jan 1, 1982	3,663,607
Twi Pharms	TENORETIC 100	atenolol; chlorthalidone	TABLET;ORAL	018760-001	Jun 8, 1984	3,663,607
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-001	Jan 5, 1996	5,637,320

Paragraph IV (Patent) Challenges for TWI PHARMS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	450 mg		2013-02-28

International Patents for Twi Pharms Drugs

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008038155

Supplementary Protection Certificates for Twi Pharms Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1261586	12C0028	France		PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
1532149	CA 2013 00001	Denmark		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
1441735	SPC/GB08/020	United Kingdom		PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102
2316456	C201730057	Spain		PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
1412357	77 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
2498758	LUC00152	Luxembourg		PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
3141251	301099	Netherlands		PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Twi Pharms
• Twi Pharms Inc