PREMPHASE (PREMARIN;CYCRIN 14/14) Drug Patent Profile

When do Premphase (premarin;cycrin 14/14) patents expire, and what generic alternatives are available?

Premphase (premarin;cycrin 14/14) is a drug marketed by Wyeth Pharms Inc and is included in one NDA.

The generic ingredient in PREMPHASE (PREMARIN;CYCRIN 14/14) is estrogens, conjugated; medroxyprogesterone acetate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estrogens, conjugated; medroxyprogesterone acetate profile page.

Summary for PREMPHASE (PREMARIN;CYCRIN 14/14)

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	71
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PREMPHASE (PREMARIN;CYCRIN 14/14)
DailyMed Link:	PREMPHASE (PREMARIN;CYCRIN 14/14) at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for PREMPHASE (PREMARIN;CYCRIN 14/14)

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03DA	Pregnen (4) derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03DA	Pregnen (4) derivatives
G03D	PROGESTOGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

L02AB	Progestogens
L02A	HORMONES AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for PREMPHASE (PREMARIN;CYCRIN 14/14)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms Inc	PREMPHASE (PREMARIN;CYCRIN 14/14)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-002	Dec 30, 1994		DISCN	No	No

Expired US Patents for PREMPHASE (PREMARIN;CYCRIN 14/14)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	PREMPHASE (PREMARIN;CYCRIN 14/14)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-002	Dec 30, 1994

International Patents for PREMPHASE (PREMARIN;CYCRIN 14/14)

See the table below for patents covering PREMPHASE (PREMARIN;CYCRIN 14/14) around the world.

Country	Patent Number	Title	Estimated Expiration
Philippines	24052	A METHOD OF HORMONAL TREATMENT OF PERIMENOPAUSAL,MENOPAUSAL AND POST-MENOPAUSAL DISORDERS
Denmark	200400365
Canada	2089707
Greece	3029620
Germany	10075037
Luxembourg	90697
Canada	1240927	METHODE DE TRAITEMENT DES TROUBLES DE LA PRE-MENOPAUSE, DE LA MENOPAUSE ET DE LA PORT-MENOPAUSE, COMPOSES ET CONDITIONNEMENT DES COMPOSES (METHOD OF TREATMENT OF PERIMENOPAUSAL, MENOPAUSAL AND POST-MENOPAUSAL DISORDER, COMPOSITIONS AND MULTI- PREPARATION PACK THEREFOR)

Supplementary Protection Certificates for PREMPHASE (PREMARIN;CYCRIN 14/14)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	SPC/GB98/034	United Kingdom		SPC/GB98/034: 20040802, EXPIRES: 20090801
0136011	SPC/GB97/032	United Kingdom		SPC/GB97/032: 20040802, EXPIRES: 20090801
0136011	97C0056	Belgium		PRODUCT NAME: OESTROGENES CONJUGUES + MEDROXYPROGESTERONACETAS; NAT. REGISTRATION NO/DATE: 428 IS 194 F 3 19970520; FIRST REGISTRATION: CH 52649 19940826
0136011	SPC/GB00/028	United Kingdom		SPC/GB00/028: 20040802, EXPIRES: 20090801
0136011	91096	Luxembourg		91096, EXPIRES: 20090802
0136011	SPC/GB00/025	United Kingdom		SPC/GB00/025: 20040802, EXPIRES: 20090801
0136011	SPC/GB02/008	United Kingdom		SPC/GB02/008: 20040802, EXPIRES: 20090801