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balcoltra Drug Patent Profile

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When do Balcoltra patents expire, and what generic alternatives are available?

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-six 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.

There are two tentative approvals for the generic drug (ethinyl estradiol; levonorgestrel), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for balcoltra

International Patents:	3
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
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

Drug patent expirations by year for balcoltra

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

Hypoallergenic metal amino acid chelates and metal amino acid chelate-containing compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ADMINISTRATION OF FERROUS BISGLYCINATE TABLETS

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Glossary

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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
Avion Pharms	BALCOLTRA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	208612-001	Jan 9, 2018	AB3	RX	Yes	Yes	⤷ Sign Up	⤷ 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

Expired US Patents for balcoltra

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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	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for balcoltra

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

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Country	Patent Number	Title	Estimated Expiration
United Kingdom	0403792		⤷ Sign Up
China	1555228		⤷ Sign Up
European Patent Office	1737470	CHELATES D'ACIDES AMINES METALLIQUES HYPOALLERGENIQUES ET COMPOSITIONS A BASE DE CHELATES D'ACIDES AMINES METALLIQUES (HYPOALLERGENIC METAL AMINO ACID CHELATES AND METAL AMINO ACID CHELATE-CONTAINING COMPOSITIONS)	⤷ Sign Up
Australia	2002331603		⤷ Sign Up
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)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2005105112		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for balcoltra

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	CA 2009 00017	Denmark	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521	93156	Luxembourg	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0771217	CA 2006 00038	Denmark	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0136011	2000C/027	Belgium	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1214076	C01214076/01	Switzerland	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	300814	Netherlands	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description