ZOLOFT Drug Patent Profile
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Which patents cover Zoloft, and what generic alternatives are available?
Zoloft is a drug marketed by Viatris and is included in two NDAs.
The generic ingredient in ZOLOFT is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zoloft
A generic version of ZOLOFT was approved as sertraline hydrochloride by ACI on June 30th, 2006.
Summary for ZOLOFT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 145 |
| Clinical Trials: | 141 |
| Patent Applications: | 4,266 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ZOLOFT |
| What excipients (inactive ingredients) are in ZOLOFT? | ZOLOFT excipients list |
| DailyMed Link: | ZOLOFT at DailyMed |
Recent Clinical Trials for ZOLOFT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mclean Hospital | Phase 4 |
| The Medical Research Network | Phase 4 |
| AbbVie | Phase 4 |
Pharmacology for ZOLOFT
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Serotonin Uptake Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ZOLOFT
Paragraph IV (Patent) Challenges for ZOLOFT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ZOLOFT | Tablets | sertraline hydrochloride | 150 mg and 200 mg | 019839 | 1 | 2005-11-09 |
| ZOLOFT | Oral Concentrate | sertraline hydrochloride | 20 mg/mL | 020990 | 1 | 2003-12-09 |
US Patents and Regulatory Information for ZOLOFT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Viatris | ZOLOFT | sertraline hydrochloride | CONCENTRATE;ORAL | 020990-001 | Dec 7, 1999 | AA | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-002 | Dec 30, 1991 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-005 | Mar 6, 1996 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-001 | Dec 30, 1991 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 ZOLOFT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-005 | Mar 6, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-002 | Dec 30, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viatris | ZOLOFT | sertraline hydrochloride | CONCENTRATE;ORAL | 020990-001 | Dec 7, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viatris | ZOLOFT | sertraline hydrochloride | CONCENTRATE;ORAL | 020990-001 | Dec 7, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZOLOFT
See the table below for patents covering ZOLOFT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 0021521 | ⤷ Try a Trial | |
| Japan | H06199743 | NEW SERUTRARIN CRYSTALLINE POLYMORPHISM AND PREPARATION THEREOF | ⤷ Try a Trial |
| Slovenia | 8012798 | ANTIDEPRESANT CIS-4-PHENYL-1,2,3,4-TETRAHYDRO-1-NAPHTHYLAMIN DERIVATIVES | ⤷ Try a Trial |
| Algeria | 2913 | Composition pharmaceutique concentrée liquide de sertraline et procédé pour sa préparation. | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZOLOFT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0030081 | SPC/GB93/048 | United Kingdom | ⤷ Try a Trial | SPC/GB93/048, EXPIRES: 20051027 |
| 0030081 | 93C0073 | Belgium | ⤷ Try a Trial | PRODUCT NAME: SERTRALINI HYDROCHLORID; NAT. REG.: 241 IS 30 F 19901119; FIRST REG.: GB PL 0057/03 19901119 |
| >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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