NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 44 pharmaceutical companies such as SUN PHARM INDS LTD, IMPAX LABS INC, RISING and others. It is marketed under 8 brand names, including DOXYCYCLINE, DOXYCYCLINE HYCLATE, DORYX and others. Available in 13 different strengths, such as EQ 150MG BASE, EQ 75MG BASE, EQ 100MG BASE and others, and administered through 5 routes including TABLET;ORAL, TABLET, DELAYED RELEASE;ORAL, CAPSULE;ORAL and others. The latest reported annual revenue is $61,625 in 2024.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"49986","ingredient":"DOXYCYCLINE","trade_name":"ORACEA","family_id":"38e7a67f2aff47c0b7b7","publication_number":"US8206740B2","cleaned_patent_number":"8206740","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-12-24","publication_date":"2012-06-26","legal_status":"Expired"} | US8206740B2 Formulation | 26 Jun, 2012 | Expired | 24 Dec, 2025 | |
| {"application_id":"50002","ingredient":"DOXYCYCLINE","trade_name":"ORACEA","family_id":"38e7a67f2aff47c0b7b7","publication_number":"US7749532B2","cleaned_patent_number":"7749532","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-19","publication_date":"2010-07-06","legal_status":"Granted"} | US7749532B2 Formulation | 06 Jul, 2010 | Granted | 19 Dec, 2027 | |
| {"application_id":"84189","ingredient":"DOXYCYCLINE HYCLATE","trade_name":"DORYX","family_id":"00eb0f2e4e2048d6b213","publication_number":"US8715724B2","cleaned_patent_number":"8715724","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-02-03","publication_date":"2014-05-06","legal_status":"Granted"} | US8715724B2 Formulation | 06 May, 2014 | Granted | 03 Feb, 2028 | |
| {"application_id":"84181","ingredient":"DOXYCYCLINE HYCLATE","trade_name":"DORYX MPC","family_id":"","publication_number":"US9295652B2","cleaned_patent_number":"9295652","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-23","publication_date":"2016-03-29","legal_status":"Granted"} | US9295652B2 Formulation | 29 Mar, 2016 | Granted | 23 Oct, 2034 | |
| {"application_id":"84184","ingredient":"DOXYCYCLINE HYCLATE","trade_name":"DORYX MPC","family_id":"320fe81ac46647bba61e","publication_number":"US9511031B2","cleaned_patent_number":"9511031","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-23","publication_date":"2016-12-06","legal_status":"Granted"} | US9511031B2 Formulation | 06 Dec, 2016 | Granted | 23 Oct, 2034 | |
| {"application_id":"84183","ingredient":"DOXYCYCLINE HYCLATE","trade_name":"DORYX MPC","family_id":"320fe81ac46647bba61e","publication_number":"US9446057B2","cleaned_patent_number":"9446057","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-12-23","publication_date":"2016-09-20","legal_status":"Granted"} | US9446057B2 Formulation | 20 Sep, 2016 | Granted | 23 Dec, 2034 |
Country wise drug prices over the years
Country wise drug revenue over the years
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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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.