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BALCOLTRA Drug Patent Profile

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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-eight 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
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
Germany	112005000909		⤷ Sign Up
United Kingdom	0403792		⤷ Sign Up
World Intellectual Property Organization (WIPO)	03016332		⤷ Sign Up
Brazil	0212399		⤷ Sign Up
China	1555228		⤷ Sign Up
South Africa	200401218	Enhancing solubility of iron amino acid chelates and iron proteinates.	⤷ 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	2009C/007	Belgium	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	93156	Luxembourg	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	39/2015	Austria	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1214076	49/2008	Austria	⤷ Sign Up	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	CA 2016 00016	Denmark	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0398460	C300221	Netherlands	⤷ Sign Up	PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description