PROMETRIUM Drug Patent Profile
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When do Prometrium patents expire, and what generic alternatives are available?
Prometrium is a drug marketed by Virtus and is included in one NDA.
The generic ingredient in PROMETRIUM is progesterone. There are fifty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the progesterone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Prometrium
A generic version of PROMETRIUM was approved as progesterone by FRESENIUS KABI USA on April 25th, 2001.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for PROMETRIUM?
- What are the global sales for PROMETRIUM?
- What is Average Wholesale Price for PROMETRIUM?
Summary for PROMETRIUM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 116 |
| Clinical Trials: | 43 |
| Patent Applications: | 5,138 |
| Drug Prices: | Drug price information for PROMETRIUM |
| What excipients (inactive ingredients) are in PROMETRIUM? | PROMETRIUM excipients list |
| DailyMed Link: | PROMETRIUM at DailyMed |
Recent Clinical Trials for PROMETRIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Cystic Fibrosis Foundation | Phase 4 |
| Johns Hopkins University | Phase 4 |
| Wake Forest University Health Sciences | Phase 2 |
Pharmacology for PROMETRIUM
| Drug Class | Progesterone |
US Patents and Regulatory Information for PROMETRIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Virtus | PROMETRIUM | progesterone | CAPSULE;ORAL | 019781-001 | May 14, 1998 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Virtus | PROMETRIUM | progesterone | CAPSULE;ORAL | 019781-002 | Oct 15, 1999 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Virtus | PROMETRIUM | progesterone | CAPSULE;ORAL | 019781-003 | Oct 15, 1999 | DISCN | No | 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 |
