Levonorgestrel Global Patent Coverage & Expiry Overview

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It is formulated by 27 pharmaceutical companies such as XIROMED, NOVAST LABS LTD, L PERRIGO CO and others. It is marketed under 39 brand names, including ALTAVERA, INTROVALE, LEVONEST and others. Available in 13 different strengths, such as 0.03MG;0.15MG, 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG, 0.75MG and others, and administered through 4 routes including TABLET;ORAL-28, TABLET;ORAL, SYSTEM;INTRAUTERINE and others.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

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US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

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Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength Route of Administration Companies Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

Patent Number Publication Date Legal Status Patent Expiry Date
{"application_id":"98191","ingredient":"ETHINYL ESTRADIOL; LEVONORGESTREL","trade_name":"QUARTETTE","family_id":"1c3076b211724a449c33","publication_number":"US8450299B2","cleaned_patent_number":"8450299","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-10-07","publication_date":"2013-05-28","legal_status":"Granted"} US8450299B2 28 May, 2013 Granted 07 Oct, 2025
{"application_id":"115216","ingredient":"LEVONORGESTREL","trade_name":"KYLEENA","family_id":"b14a08fef0024856ba76","publication_number":"US11628088B2","cleaned_patent_number":"11628088","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-02-07","publication_date":"2023-04-18","legal_status":"Granted"} US11628088B2 Formulation 18 Apr, 2023 Granted 07 Feb, 2027
{"application_id":"90642","ingredient":"ETHINYL ESTRADIOL; LEVONORGESTREL","trade_name":"BALCOLTRA","family_id":"1b1ab4391c6148309686","publication_number":"US7838042B2","cleaned_patent_number":"7838042","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-01","publication_date":"2010-11-23","legal_status":"Granted"} US7838042B2 Molecular 23 Nov, 2010 Granted 01 Jun, 2027
{"application_id":"83759","ingredient":"ETHINYL ESTRADIOL; LEVONORGESTREL","trade_name":"TWIRLA","family_id":"e2cd1a204bba44ad9489","publication_number":"US9050348B2","cleaned_patent_number":"9050348","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-07-10","publication_date":"2015-06-09","legal_status":"Granted"} US9050348B2 Formulation 09 Jun, 2015 Granted 10 Jul, 2028
{"application_id":"83758","ingredient":"ETHINYL ESTRADIOL; LEVONORGESTREL","trade_name":"TWIRLA","family_id":"e2cd1a204bba44ad9489","publication_number":"US8747888B2","cleaned_patent_number":"8747888","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-07-10","publication_date":"2014-06-10","legal_status":"Granted"} US8747888B2 Formulation 10 Jun, 2014 Granted 10 Jul, 2028
{"application_id":"83744","ingredient":"ETHINYL ESTRADIOL; LEVONORGESTREL","trade_name":"TWIRLA","family_id":"e2cd1a204bba44ad9489","publication_number":"US8246978B2","cleaned_patent_number":"8246978","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-26","publication_date":"2012-08-21","legal_status":"Granted"} US8246978B2 Formulation 21 Aug, 2012 Granted 26 Aug, 2028
{"application_id":"96084","ingredient":"ETHINYL ESTRADIOL; LEVONORGESTREL","trade_name":"LOSEASONIQUE","family_id":"89712ea5d3524e72a32a","publication_number":"US7855190B2","cleaned_patent_number":"7855190","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-05","publication_date":"2010-12-21","legal_status":"Expired"} US7855190B2 21 Dec, 2010 Expired 05 Dec, 2028
{"application_id":"98214","ingredient":"ETHINYL ESTRADIOL; LEVONORGESTREL","trade_name":"QUARTETTE","family_id":"1c3076b211724a449c33","publication_number":"US8415332B2","cleaned_patent_number":"8415332","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-11","publication_date":"2013-04-09","legal_status":"Granted"} US8415332B2 Formulation 09 Apr, 2013 Granted 11 Mar, 2029
{"application_id":"122897","ingredient":"LEVONORGESTREL","trade_name":"KYLEENA","family_id":"","publication_number":"US11850182B2","cleaned_patent_number":"11850182","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-14","publication_date":"2023-12-26","legal_status":"Granted"} US11850182B2 Formulation 26 Dec, 2023 Granted 14 Sep, 2029
{"application_id":"63176","ingredient":"LEVONORGESTREL","trade_name":"KYLEENA","family_id":"40f50199b5b045c39d77","publication_number":"US10561524B2","cleaned_patent_number":"10561524","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-16","publication_date":"2020-02-18","legal_status":"Granted"} US10561524B2 18 Feb, 2020 Granted 16 Sep, 2029
{"application_id":"63265","ingredient":"LEVONORGESTREL","trade_name":"LILETTA","family_id":"a64b0f72a2ec49c2b1dc","publication_number":"US12004992B2","cleaned_patent_number":"12004992","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-10-06","publication_date":"2024-06-11","legal_status":"Granted"} US12004992B2 Molecular 11 Jun, 2024 Granted 06 Oct, 2033
{"application_id":"63264","ingredient":"LEVONORGESTREL","trade_name":"LILETTA","family_id":"a64b0f72a2ec49c2b1dc","publication_number":"US11090186B2","cleaned_patent_number":"11090186","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-10-24","publication_date":"2021-08-17","legal_status":"Granted"} US11090186B2 17 Aug, 2021 Granted 24 Oct, 2033
{"application_id":"63243","ingredient":"LEVONORGESTREL","trade_name":"LILETTA","family_id":"a64b0f72a2ec49c2b1dc","publication_number":"US10028858B2","cleaned_patent_number":"10028858","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-22","publication_date":"2018-07-24","legal_status":"Granted"} US10028858B2 Formulation 24 Jul, 2018 Granted 22 Mar, 2034
{"application_id":"111313","ingredient":"LEVONORGESTREL","trade_name":"LILETTA","family_id":"","publication_number":"US11571328B2","cleaned_patent_number":"11571328","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-09-07","publication_date":"2023-02-07","legal_status":"Granted"} US11571328B2 Formulation 07 Feb, 2023 Granted 07 Sep, 2040

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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API Suppliers/Manufacturer (Branded/Generic companies)

Manufacturing Locations

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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.

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