BALCOLTRA Drug Patent Profile

Which patents cover Balcoltra, and when can generic versions of Balcoltra launch?

Balcoltra is a drug marketed by Avion Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has three patent family members in three countries.

The generic ingredient in BALCOLTRA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

DrugPatentWatch^® Generic Entry Outlook for Balcoltra

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for BALCOLTRA

International Patents:	3
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BALCOLTRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BALCOLTRA
What excipients (inactive ingredients) are in BALCOLTRA?	BALCOLTRA excipients list
DailyMed Link:	BALCOLTRA at DailyMed

See drug prices for BALCOLTRA

Anatomical Therapeutic Chemical (ATC) Classes for BALCOLTRA

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

G03AD	Emergency contraceptives
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for BALCOLTRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BALCOLTRA	Tablets	ethinyl estradiol; levonorgestrel	0.1 mg/0.02 mg	208612	1	2020-07-14

US Patents and Regulatory Information for BALCOLTRA

BALCOLTRA is protected by one US patents.

Patents protecting BALCOLTRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612-001	Jan 9, 2018		RX	Yes	Yes				Y

Expired US Patents for BALCOLTRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612-001	Jan 9, 2018

International Patents for BALCOLTRA

See the table below for patents covering BALCOLTRA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2457584	AMELIORATION DE LA SOLUBILITE DES CHELATES D'ACIDES AMINES DE FER ET DES PROTEINATES DE FER (ENHANCING SOLUBILITY OF IRON AMINO ACID CHELATES AND IRON PROTEINATES)
Australia	2002331603
Mexico	PA04001475	MEJORAMIENTO DE LA SOLUBILIDAD DE QUELATOS DE AMINOACIDOS DE HIERRO Y DE PROTEINATOS DE HIERRO. (ENHANCING SOLUBILITY OF IRON AMINO ACID CHELATES AND IRON PROTEINATES.)

Supplementary Protection Certificates for BALCOLTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124