ZIPSOR Drug Patent Profile
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When do Zipsor patents expire, and when can generic versions of Zipsor launch?
Zipsor is a drug marketed by Assertio and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in ZIPSOR is diclofenac potassium. There are forty-seven drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zipsor
A generic version of ZIPSOR was approved as diclofenac potassium by TEVA on August 6th, 1998.
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Questions you can ask:
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Summary for ZIPSOR
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 57 |
| Clinical Trials: | 3 |
| Patent Applications: | 4,575 |
| Drug Prices: | Drug price information for ZIPSOR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ZIPSOR |
| What excipients (inactive ingredients) are in ZIPSOR? | ZIPSOR excipients list |
| DailyMed Link: | ZIPSOR at DailyMed |
Recent Clinical Trials for ZIPSOR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Depomed | Phase 4 |
| Hospira, now a wholly owned subsidiary of Pfizer | Phase 1 |
| Hospira, Inc. | Phase 1 |
Pharmacology for ZIPSOR
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
Paragraph IV (Patent) Challenges for ZIPSOR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ZIPSOR | Capsules | diclofenac potassium | 25 mg | 022202 | 1 | 2012-11-14 |
US Patents and Regulatory Information for ZIPSOR
ZIPSOR is protected by six US patents and one FDA Regulatory Exclusivity.
Patents protecting ZIPSOR
Method of treating post-surgical acute pain
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
Method of treating post-surgical acute pain
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
Method of treating post-surgical acute pain
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
Method of treating post-surgical acute pain
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
Method of treating post-surgical acute pain
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
Method of treating post-surgical acute pain
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
FDA Regulatory Exclusivity protecting ZIPSOR
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | 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 ZIPSOR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ZIPSOR
See the table below for patents covering ZIPSOR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 69940769 | ⤷ Sign Up | |
| Ukraine | 80085 | ORAL LIQUID COMPOSITIONS | ⤷ Sign Up |
| Slovakia | 572002 | PHARMACEUTICAL COMPOSITION, METHOD FOR THE PREPARATION THEREOF AND ITS USE | ⤷ Sign Up |
| Slovenia | 20849 | Tekoči sestavki za oralno uporabo (ORAL LIQUID COMPOSITIONS) | ⤷ Sign Up |
| Croatia | P20020045 | ⤷ Sign Up | |
| Japan | 2002509103 | ⤷ Sign Up | |
| Australia | 770772 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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