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DASETTA 7/7/7 Drug Patent Profile
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When do Dasetta 7/7/7 patents expire, and when can generic versions of Dasetta 7/7/7 launch?
Dasetta 7/7/7 is a drug marketed by Novast Labs Ltd and is included in one NDA.
The generic ingredient in DASETTA 7/7/7 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
US Patents and Regulatory Information for DASETTA 7/7/7
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novast Labs Ltd | DASETTA 7/7/7 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 090946-001 | Dec 22, 2011 | AB | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
DASETTA 7/7/7 investment fundamentals: IP, exclusivity, FDA/regulatory status, competitive risk, and revenue outlook
Executive summary: DASETTA 7/7/7 (an oral contraceptive regimen: 7 active tablets then 7 active tablets then 7 inert/placebo tablets) is an older, established prescription product with a high likelihood of generic competition and limited near-term patent-driven upside. The investment case is driven mainly by (1) whether the product is still protected by listed Orange Book patents, (2) whether any method-of-use or formulation patents extend exclusivity, and (3) the pace of generic erosion by dosage form strength, labeling, and generic substitution rates. Without authenticated FDA Orange Book, patent, and litigation data for DASETTA 7/7/7 in the United States, a complete, decision-grade investment and fundamentals analysis cannot be produced.
What patents protect DASETTA 7/7/7 and what is the current Orange Book status?
Featured snippet: A decision-grade patent and exclusivity map requires the drug’s Orange Book listing(s) (application numbers, listed patents, expiration dates, and exclusivity codes). Those records are not available in the provided prompt.
Which Orange Book-listed patents typically matter for oral contraceptives
For oral contraceptives, the most investment-relevant layers usually include:
- Active ingredient and dosage form patents (composition of matter; formulation/solid-state or stability)
- Method-of-use or therapeutic-use patents (less common as defenses against generics unless tied to specific labeling)
- Manufacturing process patents (typically harder to enforce for routine ANDA manufacturing)
- Exclusivity (NCE/NDA exclusivity is usually long expired for legacy products; what matters is patent listing and any remaining periods)
What to pull from the Orange Book for DASETTA 7/7/7
A complete estate usually includes:
- Proprietary name and strength(s)
- Applicant/holder (NDA/ANDA sponsor)
- Orange Book application number(s) and submission history
- Patent numbers and expiration dates
- Exclusivity flags (e.g., 30-month stay triggers are litigation-specific; orphan status may not apply)
- Carve-outs by dosage form (tablets), route (oral), and strength
When does DASETTA 7/7/7 lose exclusivity and what are the practical generic entry timelines?
Featured snippet: Generic entry timing depends on the latest expiration among Orange Book listed patents plus any 180-day exclusivity triggered by first ANDA filer(s), and any 30-month litigation stay. Without verified Orange Book expiration dates and litigation records, the timeline cannot be quantified.
How to translate patent expiration into ANDA launch risk
For an oral contraceptive:
- If no listed patents remain, ANDA approval can proceed promptly after regulatory review.
- If listed patents remain, ANDA holders may launch “at risk” post-expiration if patent challenges succeed or if a settlement permits.
- If multiple patents exist (composition + method + formulation), the “last to expire” often governs.
What drives speed of substitution post-launch
- Bioequivalence and labeling parity (same dosing days and regimen semantics)
- Pharmacy formulary placement and automatic substitution rules
- Patient switching tolerance and prescriber comfort
- Distribution strength of the brand versus early generic entrants
How many patents cover DASETTA 7/7/7 and how strong is the patent estate?
Featured snippet: Strength is judged by (1) count of listed patents by type, (2) remaining time to expiration, (3) whether claims cover the marketed regimen as written in labeling, and (4) whether any patents are successfully invalidated or design-around.
Patent estate scoring inputs (required for DASETTA 7/7/7)
A complete scoring model requires:
- Patent count and category (composition vs formulation vs method)
- Remaining terms by jurisdiction (US) and by dosage form
- Known claim construction or invalidation outcomes
- Settlement terms tied to launch dates
Without Orange Book and litigation data, a numerical “how strong” answer cannot be supported.
What generic entry risks exist for DASETTA 7/7/7 (ANDAs, 180-day exclusivity, and Paragraph IV)?
Featured snippet: The key risk is whether generic applicants have current ANDA opportunities and whether any Paragraph IV challenges are pending or settled.
Paragraph IV and 180-day exclusivity mechanics
Generic entry risk typically accelerates when:
- A first-filer Paragraph IV ANDA is awarded 180-day exclusivity
- Litigation is settled with an agreed launch date before the last patent expiration
- Remaining patents are narrow enough for design-around (e.g., regimen instruction language, formulation details)
A complete risk view requires:
- ANDA listing history (application numbers, applicant companies)
- Paragraph IV certifications (IVA/IVB/IVC/IVD)
- Patent-specific stays and their settlement status
What patent litigation affects DASETTA 7/7/7 and what settlements control launch dates?
Featured snippet: For litigation-driven timing, the controlling items are case captions, filing dates, jurisdictions, asserted patents, and the final settlement that fixes permitted launch dates.
Litigation elements that move investment returns
- Court and venue (ED/SD vs DDel, etc.)
- Asserted patent numbers (must map to Orange Book)
- Whether injunctions were granted or stayed
- Settlement:
- “launch before/after” dates
- product-specific carve-outs by strength, NDC, and labeling
- market allocation or supply terms in some agreements
No litigation records were provided, so no accurate timeline can be built.
What is the FDA regulatory status of DASETTA 7/7/7 (NDA, labeling, approvals, and REMS)?
Featured snippet: Regulatory status is defined by NDA approval(s), label revisions, discontinuation status, and any risk management obligations. Those facts are not present in the prompt.
Key FDA items to evaluate for oral contraceptives
- NDA holder and current label wording
- Whether the product is still marketed (drug shortage/discontinuation signals)
- Any pregnancy prevention communications updates
- Any REMS program requirements (often not the main driver for classic OCPs, but must be verified)
How does DASETTA 7/7/7 compare with other 7-day and 28-day oral contraceptive regimens on patent and market share risk?
Featured snippet: In investment terms, comparison should be made by (1) whether competitors are protected by different expiration schedules, and (2) whether competitors have newer formulations or abbreviated labeling updates that keep them substitutable on formularies.
What comparative analysis requires
A credible comparison requires:
- Identifying the same hormone combination across competitor regimens
- Checking each product’s Orange Book listing and patent expirations
- Mapping ANDA filings and market entries against NDCs and strengths
No competitor list and no active ingredient mapping were provided, so a compliant comparison cannot be produced.
What formulations are protected for DASETTA 7/7/7 and what manufacturing/IP barriers exist?
Featured snippet: For generics, formulation and manufacturing patents only matter if they are still listed and still enforceable against the ANDA pathway.
Typical IP barriers for oral contraceptive tablets
- Stability-driven formulation patents (if still protected)
- Coating or excipient process improvements tied to dissolution and bioavailability
- Manufacturing process steps that are claimed and not generic-equivalent
A formulation barrier analysis requires:
- Specific listed formulation/manufacturing patent claims and expiration
- Whether generics can design around without breaking bioequivalence
No such patent identifiers were supplied.
Commercial fundamentals: what revenue and demand drivers matter most for DASETTA 7/7/7?
Featured snippet: For an established oral contraceptive regimen, commercial fundamentals typically hinge on prescription volume stability, generic share capture, and channel stocking.
Demand drivers
- Contraception category resilience versus demographic shifts
- Switching behavior from brand to generic (often rapid once generics are available)
- Managed care formularies and rebate structures
- Compliance factors tied to regimen clarity
Supply and channel constraints
- Whether multiple generic NDCs exist and whether shortages trigger brand resurgence
- Distributor relationships and tender schedules (not disclosed in prompt)
Investment implication without monetization inputs
Without verified sales, NDC-level shipment trends, and pricing history, a quantified revenue outlook cannot be produced.
Geographic coverage: is DASETTA 7/7/7 protected or sold outside the US in ways that change the investment thesis?
Featured snippet: Cross-border protection can extend exclusivity in jurisdictions outside the US, but the investment thesis usually relies on US regulatory and market access first for ANDA-driven competition.
No international approvals, patent filings, or marketing authorizations were provided.
Key Takeaways
- A complete investment-grade fundamentals analysis for DASETTA 7/7/7 requires US Orange Book patent listing data (NDA application number, listed patents, expiration dates) and, where relevant, ANDA Paragraph IV and litigation outcomes.
- The investment case for a legacy oral contraceptive product typically hinges on whether any Orange Book patents remain and whether generics are already positioned to enter.
- No patent, FDA, litigation, settlement, or commercial data were provided in the prompt, so a decision-grade analysis cannot be produced.
FAQs
- How do Orange Book listed patents determine generic launch timing for an oral contraceptive regimen like DASETTA 7/7/7?
- What is the role of Paragraph IV certifications and 30-month stays in ANDA entry for older prescription contraceptives?
- Which Orange Book patent categories (composition, formulation, method-of-use) most often block generic substitution?
- How do NDC-level availability and generic plurality affect brand pricing and prescription switching for contraceptives?
- What settlement terms most commonly govern launch dates in US oral contraceptive patent disputes?
References (APA)
(No sources were provided or cited in the prompt.)
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