NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 45 pharmaceutical companies such as MYLAN PHARMS INC, AUROBINDO PHARMA, CHARTWELL RX and others. It is marketed under 5 brand names, including VALACYCLOVIR HYDROCHLORIDE, ACYCLOVIR, SITAVIG and others. Available in 12 different strengths, such as EQ 500MG BASE, EQ 1GM BASE, 5% and others, and administered through 8 routes including TABLET;ORAL, OINTMENT;TOPICAL, TABLET;BUCCAL and others.
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Licensing: 45 potential partnersUS Launch window: Loading launch window...
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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":"88930","ingredient":"ACYCLOVIR","trade_name":"SITAVIG","family_id":"6094f7c9744d42a1b2c1","publication_number":"US8791127B2","cleaned_patent_number":"8791127","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-03-23","publication_date":"2014-07-29","legal_status":"Granted"} | US8791127B2 Formulation | 29 Jul, 2014 | Granted | 23 Mar, 2027 | |
| {"application_id":"88901","ingredient":"ACYCLOVIR","trade_name":"SITAVIG","family_id":"6094f7c9744d42a1b2c1","publication_number":"US8747896B2","cleaned_patent_number":"8747896","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-03","publication_date":"2014-06-10","legal_status":"Granted"} | US8747896B2 Formulation | 10 Jun, 2014 | Granted | 03 Jun, 2027 | |
| {"application_id":"88937","ingredient":"ACYCLOVIR","trade_name":"SITAVIG","family_id":"1b42ce7c58a24b008a66","publication_number":"US8592434B2","cleaned_patent_number":"8592434","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-06-16","publication_date":"2013-11-26","legal_status":"Granted"} | US8592434B2 Formulation | 26 Nov, 2013 | Granted | 16 Jun, 2030 |
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.