PITOCIN Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Pitocin, and what generic alternatives are available?
Pitocin is a drug marketed by Par Sterile Products and is included in one NDA.
The generic ingredient in PITOCIN is oxytocin. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the oxytocin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pitocin
A generic version of PITOCIN was approved as oxytocin by HIKMA on January 10th, 2007.
Summary for PITOCIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 59 |
| Clinical Trials: | 103 |
| Patent Applications: | 3,936 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PITOCIN |
| What excipients (inactive ingredients) are in PITOCIN? | PITOCIN excipients list |
| DailyMed Link: | PITOCIN at DailyMed |
Recent Clinical Trials for PITOCIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | Phase 1 |
| Wake Forest University Health Sciences | Phase 1 |
| Beth Israel Deaconess Medical Center | Phase 4 |
Pharmacology for PITOCIN
| Drug Class | Oxytocic |
| Physiological Effect | Increased Uterine Smooth Muscle Contraction or Tone |
Anatomical Therapeutic Chemical (ATC) Classes for PITOCIN
US Patents and Regulatory Information for PITOCIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Sterile Products | PITOCIN | oxytocin | INJECTABLE;INJECTION | 018261-001 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Par Sterile Products | PITOCIN | oxytocin | INJECTABLE;INJECTION | 018261-002 | Jul 27, 2007 | AP | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Par Sterile Products | PITOCIN | oxytocin | INJECTABLE;INJECTION | 018261-003 | Sep 5, 2012 | 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 |
