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-nine 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 STRIDES PHARMA on June 30th, 2006.
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Summary for ZOLOFT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 147 |
| Clinical Trials: | 143 |
| Patent Applications: | 5,076 |
| Drug Prices: | Drug price information for ZOLOFT |
| Drug Sales Revenues: | Drug sales revenues 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 |
|---|---|
| Anagnostou, Evdokia, M.D. | Phase 2 |
| Ontario Brain Institute | Phase 2 |
| University of Alberta | Phase 2 |
Pharmacology for ZOLOFT
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Serotonin Uptake Inhibitors |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-002 | Dec 30, 1991 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-005 | Mar 6, 1996 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-001 | Dec 30, 1991 | AB | RX | Yes | No | ⤷ 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 ZOLOFT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-001 | Dec 30, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-001 | Dec 30, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Viatris | ZOLOFT | sertraline hydrochloride | TABLET;ORAL | 019839-005 | Mar 6, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Viatris | ZOLOFT | sertraline hydrochloride | CONCENTRATE;ORAL | 020990-001 | Dec 7, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Iceland | 5906 | ⤷ Sign Up | |
| Israel | 96146 | Use of sertraline for the preparation of medicaments for treating anxiety-related disorders | ⤷ Sign Up |
| European Patent Office | 1125581 | ⤷ Sign Up | |
| Czechoslovakia | 238618 | PRODUCTION METHOD OF NEW DERIVATIVES OF CIS-4-PHENYL-1,2,3,4-TETRAHYDRO-1-NAPHTALENAMINES | ⤷ Sign Up |
| >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 | ⤷ Sign Up | SPC/GB93/048, EXPIRES: 20051027 |
| 0030081 | 93C0073 | Belgium | ⤷ Sign Up | 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.
ISSN: 2162-2639
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