ACTIVELLA Drug Patent Profile
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Which patents cover Activella, and when can generic versions of Activella launch?
Activella is a drug marketed by Amneal and is included in one NDA.
The generic ingredient in ACTIVELLA is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Activella
A generic version of ACTIVELLA was approved as estradiol; norethindrone acetate by BRECKENRIDGE PHARM on April 17th, 2008.
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Summary for ACTIVELLA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 76 |
| Clinical Trials: | 6 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ACTIVELLA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACTIVELLA |
| What excipients (inactive ingredients) are in ACTIVELLA? | ACTIVELLA excipients list |
| DailyMed Link: | ACTIVELLA at DailyMed |
Recent Clinical Trials for ACTIVELLA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AbbVie | Phase 3 |
| Gretchen Wells | Phase 4 |
| AbbVie | Phase 2 |
Pharmacology for ACTIVELLA
| Drug Class | Estrogen Progestin |
| Mechanism of Action | Estrogen Receptor Agonists |
US Patents and Regulatory Information for ACTIVELLA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-002 | Dec 28, 2006 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 ACTIVELLA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Amneal | ACTIVELLA | estradiol; norethindrone acetate | TABLET;ORAL | 020907-001 | Nov 18, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACTIVELLA
See the table below for patents covering ACTIVELLA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 3140584 | ⤷ Sign Up | |
| Luxembourg | 91096 | ⤷ Sign Up | |
| Luxembourg | 90697 | ⤷ Sign Up | |
| Germany | 19775086 | ⤷ Sign Up | |
| Denmark | 200400365 | ⤷ Sign Up | |
| Germany | 10199001 | ⤷ Sign Up | |
| Netherlands | 980038 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACTIVELLA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0136011 | SPC/GB00/025 | United Kingdom | ⤷ Sign Up | SPC/GB00/025: 20040802, EXPIRES: 20090801 |
| 0136011 | 99C0003 | Belgium | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306 |
| 1453521 | 93156 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 0136011 | 91096 | Luxembourg | ⤷ Sign Up | 91096, EXPIRES: 20090802 |
| 0136011 | SPC/GB98/034 | United Kingdom | ⤷ Sign Up | SPC/GB98/034: 20040802, EXPIRES: 20090801 |
| 1453521 | 300814 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 0136011 | SPC/GB00/028 | United Kingdom | ⤷ Sign Up | SPC/GB00/028: 20040802, EXPIRES: 20090801 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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