Testosterone Enanthate Global Patent Coverage & Expiry Overview

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It is formulated by 3 pharmaceutical companies such as HIKMA FARMACEUTICA, ANTARES PHARMA INC, EUGIA PHARMA. It is marketed under 2 brand names, including TESTOSTERONE ENANTHATE, XYOSTED (AUTOINJECTOR). Available in 4 different strengths, such as 200MG/ML, 50MG/0.5ML (50MG/0.5ML), 75MG/0.5ML (75MG/0.5ML) and others, and administered through 2 routes including INJECTABLE;INJECTION, SOLUTION;SUBCUTANEOUS.

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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":"71479","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"277272c15e8842a9bcdd","publication_number":"US9533102B2","cleaned_patent_number":"9533102","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-24","publication_date":"2017-01-03","legal_status":"Granted"} US9533102B2 Formulation 03 Jan, 2017 Granted 24 Jan, 2026
{"application_id":"71494","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"277272c15e8842a9bcdd","publication_number":"US8562564B2","cleaned_patent_number":"8562564","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-24","publication_date":"2013-10-22","legal_status":"Granted"} US8562564B2 Formulation 22 Oct, 2013 Granted 24 Jan, 2026
{"application_id":"71495","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"277272c15e8842a9bcdd","publication_number":"US9180259B2","cleaned_patent_number":"9180259","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-24","publication_date":"2015-11-10","legal_status":"Granted"} US9180259B2 Formulation 10 Nov, 2015 Granted 24 Jan, 2026
{"application_id":"71497","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"277272c15e8842a9bcdd","publication_number":"US10478560B2","cleaned_patent_number":"10478560","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-24","publication_date":"2019-11-19","legal_status":"Granted"} US10478560B2 Formulation 19 Nov, 2019 Granted 24 Jan, 2026
{"application_id":"71496","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"277272c15e8842a9bcdd","publication_number":"US9629959B2","cleaned_patent_number":"9629959","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-24","publication_date":"2017-04-25","legal_status":"Granted"} US9629959B2 Formulation 25 Apr, 2017 Granted 24 Jan, 2026
{"application_id":"71499","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"2dc48a0f7fc946c5af58","publication_number":"US11446441B2","cleaned_patent_number":"11446441","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-24","publication_date":"2022-09-20","legal_status":"Granted"} US11446441B2 Formulation 20 Sep, 2022 Granted 24 Jan, 2026
{"application_id":"71493","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"277272c15e8842a9bcdd","publication_number":"US8021335B2","cleaned_patent_number":"8021335","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-10-04","publication_date":"2011-09-20","legal_status":"Granted"} US8021335B2 Formulation 20 Sep, 2011 Granted 04 Oct, 2026
{"application_id":"79479","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"c339f12d052b4dafa53f","publication_number":"US11497753B2","cleaned_patent_number":"11497753","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-03-19","publication_date":"2022-11-15","legal_status":"Granted"} US11497753B2 Formulation 15 Nov, 2022 Granted 19 Mar, 2030
{"application_id":"71529","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"b7881c3340204d44aa15","publication_number":"US10279131B2","cleaned_patent_number":"10279131","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-07-31","publication_date":"2019-05-07","legal_status":"Granted"} US10279131B2 Formulation 07 May, 2019 Granted 31 Jul, 2031
{"application_id":"71530","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"b7881c3340204d44aa15","publication_number":"US10357609B2","cleaned_patent_number":"10357609","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-21","publication_date":"2019-07-23","legal_status":"Granted"} US10357609B2 Formulation 23 Jul, 2019 Granted 21 Aug, 2031
{"application_id":"71533","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"b7881c3340204d44aa15","publication_number":"US10905827B2","cleaned_patent_number":"10905827","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-21","publication_date":"2021-02-02","legal_status":"Granted"} US10905827B2 Formulation 02 Feb, 2021 Granted 21 Aug, 2031
{"application_id":"71536","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"4c73b92d2c45454a85a2","publication_number":"US11446440B2","cleaned_patent_number":"11446440","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-21","publication_date":"2022-09-20","legal_status":"Granted"} US11446440B2 Formulation 20 Sep, 2022 Granted 21 Aug, 2031
{"application_id":"80362","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"ed1efe55eeb2480c8f41","publication_number":"US11844804B2","cleaned_patent_number":"11844804","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-06-04","publication_date":"2023-12-19","legal_status":"Granted"} US11844804B2 19 Dec, 2023 Granted 04 Jun, 2033
{"application_id":"71531","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"b7881c3340204d44aa15","publication_number":"US10821072B2","cleaned_patent_number":"10821072","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-06-04","publication_date":"2020-11-03","legal_status":"Granted"} US10821072B2 Formulation 03 Nov, 2020 Granted 04 Jun, 2033
{"application_id":"71532","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"b7881c3340204d44aa15","publication_number":"US10881798B2","cleaned_patent_number":"10881798","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-02-11","publication_date":"2021-01-05","legal_status":"Granted"} US10881798B2 Formulation 05 Jan, 2021 Granted 11 Feb, 2034
{"application_id":"80366","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"664bdb44bf5a4ee18829","publication_number":"US11160751B2","cleaned_patent_number":"11160751","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-07","publication_date":"2021-11-02","legal_status":"Granted"} US11160751B2 Formulation 02 Nov, 2021 Granted 07 Oct, 2034
{"application_id":"80361","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"ed1efe55eeb2480c8f41","publication_number":"US10238662B2","cleaned_patent_number":"10238662","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-02-19","publication_date":"2019-03-26","legal_status":"Granted"} US10238662B2 Formulation 26 Mar, 2019 Granted 19 Feb, 2035
{"application_id":"80356","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"ed1efe55eeb2480c8f41","publication_number":"US10912782B2","cleaned_patent_number":"10912782","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-02-19","publication_date":"2021-02-09","legal_status":"Granted"} US10912782B2 Formulation 09 Feb, 2021 Granted 19 Feb, 2035
{"application_id":"71538","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"4a343706e157479f8119","publication_number":"US11813435B2","cleaned_patent_number":"11813435","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-02-25","publication_date":"2023-11-14","legal_status":"Granted"} US11813435B2 Formulation 14 Nov, 2023 Granted 25 Feb, 2035
{"application_id":"80376","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"f091767e066d46788ecd","publication_number":"US11191908B2","cleaned_patent_number":"11191908","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-18","publication_date":"2021-12-07","legal_status":"Granted"} US11191908B2 Formulation 07 Dec, 2021 Granted 18 Oct, 2035
{"application_id":"71527","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"b7881c3340204d44aa15","publication_number":"US9744302B2","cleaned_patent_number":"9744302","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-11-19","publication_date":"2017-08-29","legal_status":"Granted"} US9744302B2 Formulation 29 Aug, 2017 Granted 19 Nov, 2035
{"application_id":"71528","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"b7881c3340204d44aa15","publication_number":"US9950125B2","cleaned_patent_number":"9950125","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-09-04","publication_date":"2018-04-24","legal_status":"Granted"} US9950125B2 Formulation 24 Apr, 2018 Granted 04 Sep, 2036
{"application_id":"80388","ingredient":"TESTOSTERONE ENANTHATE","trade_name":"XYOSTED (AUTOINJECTOR)","family_id":"8717823215dd42b9a05f","publication_number":"US10646495B2","cleaned_patent_number":"10646495","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-08-30","publication_date":"2020-05-12","legal_status":"Granted"} US10646495B2 Formulation 12 May, 2020 Granted 30 Aug, 2038

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