ARTHROTEC Drug Patent Profile
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When do Arthrotec patents expire, and when can generic versions of Arthrotec launch?
Arthrotec is a drug marketed by Pfizer and is included in one NDA.
The generic ingredient in ARTHROTEC is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Arthrotec
A generic version of ARTHROTEC was approved as diclofenac sodium; misoprostol by ACTAVIS LABS FL INC on July 9th, 2012.
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Questions you can ask:
- What is the 5 year forecast for ARTHROTEC?
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- What is Average Wholesale Price for ARTHROTEC?
Summary for ARTHROTEC
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 17 |
| Clinical Trials: | 1 |
| Drug Prices: | Drug price information for ARTHROTEC |
| What excipients (inactive ingredients) are in ARTHROTEC? | ARTHROTEC excipients list |
| DailyMed Link: | ARTHROTEC at DailyMed |
Recent Clinical Trials for ARTHROTEC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| POZEN | Phase 3 |
Pharmacology for ARTHROTEC
| Drug Class | Nonsteroidal Anti-inflammatory Drug Prostaglandin E1 Analog |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
Paragraph IV (Patent) Challenges for ARTHROTEC
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ARTHROTEC | Delayed-release Tablets | diclofenac sodium; misoprostol | 50 mg/0.2 mg | 020607 | 1 | 2009-06-29 |
| ARTHROTEC | Delayed-release Tablets | diclofenac sodium; misoprostol | 75 mg/0.2 mg | 020607 | 1 | 2008-11-28 |
US Patents and Regulatory Information for ARTHROTEC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-001 | Dec 24, 1997 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-002 | Dec 24, 1997 | 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 ARTHROTEC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-001 | Dec 24, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-002 | Dec 24, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-002 | Dec 24, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-002 | Dec 24, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-001 | Dec 24, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| Pfizer | ARTHROTEC | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 020607-001 | Dec 24, 1997 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ARTHROTEC
See the table below for patents covering ARTHROTEC around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2071312 | ⤷ Sign Up | |
| European Patent Office | 0527887 | COMPOSITION PHARMACEUTIQUE. (PHARMACEUTICAL COMPOSITION.) | ⤷ Sign Up |
| Australia | 7876491 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 9116895 | ⤷ Sign Up | |
| Canada | 2082944 | COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS) | ⤷ Sign Up |
| New Zealand | 238024 | PHARMACEUTICAL COMPOSITIONS COMPRISING A CORE OF DICLOFENAC OR PIROXICAM AND A MANTLE COATING OF A PROSTAGLANDIN | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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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